Highlights of the European Respiratory Society (ERS) 2013

Table of Contents

MRC or CAT: Does the Choice Matter? Is There A Need To Change The Antibiotic Prescribing Practices In Nursing Home Acquired Pneumonia (NHAP)? Never Smokers with COPD Have Milder Disease than Current and Former Smokers Prediction of MDR Bacterial Pneumonia in Patients from the Community Asthma-COPD Overlap: A Subgroup of Severe Asthma with Greater Hospitalization Risk but Lower Lung Function

Decline than COPD? Low Level Laser Therapy Is an Effective Supplementary Treatment Option in Moderate to Severe Persistent Asthmatics High Dose N-Acetylcysteine Prevents COPD Exacerbations Low Sleep Quality in Newly Diagnosed Lung Cancer Patients Long Term Mortality in Patients with CAPCOPD Is Twice as High as in Non-COPD-CAP Add-On Tiotropium Improves Lung Function and Asthma Control in Asthma Respiratory Symptoms Are the Most Common Reason for Doctor Visits amongst Children in India Evaluation of Sleep Related Breathing Disorders in Patients with Interstitial Lung Disease ICS Can be Safely Withdrawn in Patients with Mild-Moderate COPD Patients Sustained Control In Severe Asthmatics: Is It Possible? Platelet Count as a Marker of CAP Outcome Single Agent Gemcitabine or Docetaxel in the Second-Line Therapy for NSCLC Chronic Cough, Asthma-Like Symptoms and Normal Spirometry: Is It Asthma? Non-tuberculous Mycobacterial Lung Disease - Is Low Body Fat The Cause? Altered Respiratory Status Observed In More Than 80% of Females Working In the Manual Brick Making Units in India Similar Systemic Exposure Profile Seen In Two Mometasone Furoate Nasal Spray Formulations Bacteremia in Non-HIV Community Acquired Pneumonia Metabolomic Profile: A New Approach to Tuberculosis Diagnosis Long Acting Bronchodilators Exhibit A Similar Cardiovascular Safety Profile in COPD Spirometry Use has Improved in India Characterizing Asthma-COPD Overlap in the Elderly Acute Infections with M. pneumoniae and Cl. pneumoniae in Children with Uncontrolled Asthma Beware: Even E-Cigarettes are Harmful! Salmeterol Fluticasone BAI as Good as pMDI with High Patient Preference Efficacy of Fluticasone/Formoterol Combination versus Fluticasone Right Middle Lobe Can Be Safely Treated With Bronchial Thermoplasty Linezolid in the Treatment of Patients with MDR TB and XDR TB Bronchoscopic Hot Saline Ablation (BHSA): A Different Approach for Emphysema Pulse Transit Time: An Effective Diagnostic Tool for Paediatric Sleep Disorders Assessment of Severity of ICU-Acquired Pneumonia and Association with Aetiology Real-Life Investigation of Prescriptions Following Initial COPD Diagnosis

MRC or CAT: Does the Choice Matter? Vant Hul A et al. Chronic obstructive pulmonary disease (COPD) severity classification is based on airway obstruction, frequency of exacerbations and disease severity as per the recent Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. Either Modified

Medical Research Council (MRC) dyspnea score or the COPD assessment test (CAT) can be used to classify symptom severity. CAT assessment contains questionnaire on dyspnea along with other parameters, hence a difference in the outcome compared to MRC is possible. The current study evaluated the effect of choice for MRC and CAT on the new GOLD severity classification in 125 patients (age 6410 years) referred to the pulmonologist between April and December 2012. Symptom severity was assessed by using MRC and CAT, to measure airway obstruction spirometry was performed and annual exacerbation rate was recorded. Patients classified based on the airway obstruction were GOLD-I 24%, GOLD-II 43%, GOLD-III 26% and GOLD-IV 7%. The patients classified on MRC score were 0- 3%, I- 22%, II- 25%, III- 25%, IV- 12%, V- 13%. The average CAT score was 17.77.2. The outcomes with respect to GOLD classification based on the MRC or CAT were

GOLD A: MRC- 33%, CAT- 10% GOLD B: MRC- 18%, CAT- 40% GOLD C: MRC- 16%, CAT- 2% GOLD D: MRC- 33%, CAT- 48%

Larger proportion of patients were classified in the severe group (i.e. GOLD B and D) using CAT and using MRC, larger proportion were classified in the GOLD A and C group. In classifying GOLD symptom severity, the choice of MRC and CAT largely affects the outcomes. P5111, presented at European Respiratory Society (ERS) conference 2013 Is There A Need To Change The Antibiotic Prescribing Practices In Nursing Home Acquired Pneumonia (NHAP)? Rother C et al. The microorganism found in the hospital setup differs fairly with that of the community. Hence it has been suggested that pneumonia which is acquired in nursing home (NHAP) should be managed differently to community-acquired pneumonia (CAP) due to a higher frequency of potentially resistant pathogens in nursing homes. Therefore a study was conducted which described two analyses: the first analysis included, a prospective observational study conducted on 1883 patients with CAP. This study compared the microbiology between NHAP and CAP patients. Based on admission residency status, patients were classified as NHAP or CAP patients. The second analysis included the systematic review and meta-analysis from all published comparative studies. This was to compare the microbiology and outcomes of NHAP to CAP. Methicillin resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and enterobactericeae were the potentially resistant organisms. The prospective study included 171 nursing home residents. S. pneumoniae was the most frequent causative organism in both the groups. There was no increased frequency of MRSA (0.6% vs. 0.4%), P. aeruginosa (0.6% vs. 0.5%) or enterobactericeae (2.3% vs. 1.2%) in NHAP compared to CAP. In the second analysis, 6 studies including 6444 patients were identified. There was no significant increase in the frequency of MRSA (OR 0.28) or P. aeruginosa (0.63) but a statistically significant increase in enterobactericeae (1.41) was recognized. Thus the results of the study do not support a change in antibiotic prescribing practices for NHAP patients. P5047, presented at European Respiratory Society (ERS) conference 2013

Never Smokers with COPD Have Milder Disease than Current and Former Smokers
Lange P et al. It is well-known that apart from smokers, COPD is caused in a substantial number of non-smokers too. However very little is known about the characteristics and consequences of this disease in the non-smokers compared to smokers. Researchers from Denmark, found that the disease was milder in the never smokers as compared to the current and former smokers. They compared 68,501 volunteers from the general population of which 1,476 never smokers, 2,696 former smokers and 2,451 current smokers had spirometry confirmed COPD. This population was compared with 24,529 never smokers without COPD. Though it was seen that the never smokers had milder disease, which was limited to the lungs however incidence of pneumonia, COPD hospitalizations were higher than the non smokers. There were no cases of lung cancer among the never smokers. The risk of CV co-morbidities and all-cause mortality was also not increased in the never smokers. 4867, presented at European Respiratory Society (ERS) conference 2013

Prediction of MDR Bacterial Pneumonia in Patients from the Community

Aliberti S et al. Recent studies suggest that probabilistic scores may identify pneumonia caused by multidrug-resistant (MDR) bacteria. An abstract presented at ERS this year evaluated the prevalence and characteristics of MDR bacterial pneumonia in hospitalized patients from the community. Validated Aliberti and Shorr scores in MDR pneumonia prediction, compared to healthcare associated pneumonia (HCAP) classification were used.

Two independent European cohorts of consecutive hospitalized pneumonia patients were prospectively evaluated in Barcelona, Spain (BC) and Edinburgh, UK (EC). A total of 1,591 patients in the BC and 1,883 patients in the EC were enrolled. Data on admission and during hospitalization were recorded. The predictive value of the three scores was determined for correctly indicating the presence of MDR pneumonia using a receiveroperating characteristic (ROC) curve. The prevalence of patients with MDR pathogen among those with isolated bacteria was 7.6% in the BC and 3.3% in the EC. MRSA was the most common MDR pathogen found in both cohorts, followed by MDR P. aeruginosa. ICU patients had a significantly higher prevalence of MDR bacteria. The two probabilistic scores, and particularly the Aliberti score, showed a higher area under the ROC curve than the HCAP classification in predicting MDR pneumonia, especially in the ICU. Risk scores which can identify MDR pneumonia can help in the development of antimicrobial stewardship strategies. P5049, presented at European Respiratory Society (ERS) conference 2013

Asthma-COPD Overlap: A Subgroup of Severe Asthma with Greater Hospitalization Risk but Lower Lung Function Decline than COPD?
De Marco R et al. It is still unclear whether asthma-chronic obstructive pulmonary disease (COPD) overlap is the consequence of asthma progressed to fixed airflow obstruction or COPD with airway hyperresponsiveness or an independent phenotype. To gain some knowledge in this direction a multicentre, international, 9-year, prospective trial studied subjects with current asthma (n=964), COPD (n=231) or both (n=223) and neither of the three (n=5573). The lung function decline as measured by change in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) and hospitalization for respiratory symptoms in these subjects was analyzed after adjusting for age, sex and height. The subjects with asthma-COPD overlap had the lowest lung function and similar familiarity to asthma and childhood respiratory infections compared to subjects with only asthma, at the baseline. Also, the COPD group subjects had greatest exposure to smoking at baseline. In the follow-up, subjects with COPD had a significantly (p < 0.001) greater decline in lung function (change in FEV1= 37 ml/year, change in FVC= 35 ml/year) as compared to only asthma (change in FEV1= 28 ml/year, change in FVC= 23 ml/year) or asthmaCOPD overlap (change in FEV1= 28 ml/year, change in FVC= 24 ml/year) subjects. However subjects with asthma-COPD overlap had 20% greater risk of hospitalization versus subjects with only asthma and 14% greater risk of hospitalization versus subjects with only COPD (p<0.001 for both). Hence the investigators concluded that individuals with asthma-COPD overlap could be a subgroup of individuals with severe asthma having a greater risk of hospitalization but lower lung function decline as compared to individuals with COPD. 4871, presented at European Respiratory Society (ERS) conference 2013

Low Level Laser Therapy Is an Effective Supplementary Treatment Option in Moderate to Severe Persistent Asthmatics
Kiani A et al. A recent study presented at ERS has shown the effectiveness of low level laser (LLL) therapy, as an add-on therapeutic option along with the convention medications in asthma. Conventional asthma medications do not affect peripheral and smaller airways of the respiratory tract. Hence LLL therapy could be an effective supplementary treatment option in managing the patients with moderate to severe persistent asthma. The present study was a double-blind, placebo controlled trial done on 33 moderate to severe persistent asthmatics. Patients were allocated to two groups; one group received medical treatment plus LLL as an add-on therapy, and the other group was managed with medical therapy with sham-LLL. Mean FEV1 and PEF values differed significantly after LLL therapy between laser and placebo groups (p<0.002, p<0.0001 respectively). There was a significant difference in the mean values of FEV1 (p = 0.001) and PEF (p<0.0001) for pre-radiation and post-radiation values. Further laser radiation caused a statistically significant reduction on asthma severity grade (p=0.004); number of medical visits (p<0.0001); daily symptoms (p<0.001) and nocturnal symptoms (p<0.0001) compared with the placebo group. Thus LLL was found to be effective in the treatment of asthma. Considering the simplicity of use and acceptable efficacy, LLL can be considered as a complementary therapeutic option in combination with conventional asthma treatments in patients with mild to moderate symptoms. P5096, presented at European Respiratory Society (ERS) conference 2013

High Dose N-Acetylcysteine Prevents COPD Exacerbations

Zheng P J et al. A latest study presented at ERS 2013 conference revealed that high dose of N-acetylcysteine (NAC) reduces the exacerbations in COPD patients.

The aim of the present study was to evaluate the efficacy of long-term, high dose (1200 mg/day) antioxidant N-acetylcysteine (NAC) treatment in reducing exacerbations in COPD patients with and without inhaled corticosteroids (ICS). This was a prospective, stratified, randomized, double-blind, placebo-controlled, parallel-group trial consisting of 1006 COPD patients (post bronchodilator FEV1: 48.95+11.80 of predicted) classified as GOLD II and III in terms of severity. After 2 week run in period, patients were randomly assigned to receive NAC tablets (1200 mg/day) for 1 year. After 1 year of treatment, the results obtained were as follows -

22% reduction in exacerbations (risk ratio 0.78, p=0.001) in the NAC group compared to the placebo group. The reduction of exacerbation appeared regardless of ICS use. NAC 1200mg/day treatment was well tolerated.

Thus it was concluded that NAC 1200mg/day is an effective and safe treatment in preventing acute exacerbations for moderate to severe COPD patients. P3394, presented at European Respiratory Society (ERS) conference 2013

Long Term Mortality in Patients with CAPCOPD Is Twice as High as in Non-COPD-CAP

Braeken D et al. German researchers analyzed 988 patients enrolled with community acquired pneumonia (CAP) to identify the impact of COPD on the outcomes (severity and mortality) of CAP. Patients were followed up for 6 months. CAP COPD patients had higher CURB 65 scores, length of stay, urea levels, glucose levels and leukocytes. No differences were observed in 30 day mortality and cause of death but COPD patients had a higher 180 day mortality rate (p = 0.058, OR = 1.91; 95% CI 0.97 -375), compared to CAP only patients. It was found that the 6 month mortality was associated with increased age and increased CURB-65 score. These findings therefore call for further research in order to improve the management of patients with COPD-CAP. 3321, presented at European Respiratory Society (ERS) conference 2013

Add-On Tiotropium Improves Lung Function and Asthma Control in Asthma

Jorge M and Kerstjens H et al. Previous studies have shown that tiotropium significantly improves lung function and asthma control in asthmatics. A meta-analysis consisting of 19 studies done on a total of 1643 patients, evaluated the efficacy of tiotropium as an add-on therapy to standard controller regimens in uncontrolled asthmatics. Patients in the tiotropium group showed a statistically significant improvement in FEV1 (p<0.00001), morning PEF (p<0.00001), and evening PEF (p<0.00001). Patients taking tiotropium experienced a reduction in rescue medication usage and improvement in quality of life. Another double-blind, double dummy, parallel group study analyzed the asthma control questionnaire (ACQ) data in 2103 asthmatics symptomatic despite on medium dose of inhaled corticosteroid (ICS). These symptomatic asthmatics received a dose of tiotropium along with the regular controller therapy. Tiotropium was found to significantly improve (p=0.03) the ACQ responder rate at 24 weeks compared with placebo. Thus tiotropium was found to be associated with a statistically significant improvement in pulmonary function in uncontrolled asthmatics and also provided a statistically significant improvement in asthma control in asthmatics symptomatic on ICS therapy. P4130 and 3542, presented at European Respiratory Society (ERS) conference 2013

Respiratory Symptoms Are the Most Common Reason for Doctor Visits amongst Children in India
Madas S et al. It has emerged from a large study that over 60% children in India visit their doctor for respiratory symptoms most commonly because of upper and lower respiratory tract infections and asthma. This data is the result of a one day point prevalence study involving 65,979 children from India visiting 7400 primary care physicians. The participating doctors completed a validated questionnaire based on ICD-10 classification. The age, gender, symptoms and diseases of all the patients visiting on the study day was captured and clean data was provided which was analysed by the investigators. Fever was the most common symptom present in 49.1% children where as 61.3% children presented respiratory symptoms such as cough (40.3%),rhinitis (24.5%) sore throat (9.9%), wheeze (11.3%) and breathlessness (6%). The gastrointestinal and skin related symptoms were present in 30% and 9.4% of patients respectively. The most common diagnoses were, upper and lower respiratory tract infections (9.9% and 6.8% respectively), ear ache/infections (5.2%) and asthma (3.9%). Asthma and lower respiratory tract infections were more common in non-metropolitan cities than metropolitan cities (odds ratio (OR): 1.29 p< 0.0001 for asthma and OR: 1.47 p<0.0001 for lower respiratory tract infections). The researchers concluded that other than respiratory symptoms due to respiratory tract infections and asthma being the most common reason for a doctor visit in Indian children and adolescents, asthma and lower respiratory tract infections were reported

more commonly in the non-metropolitan cities in India. P4325, presented at European Respiratory Society (ERS) conference 2013

Evaluation of Sleep Related Breathing Disorders in Patients with Interstitial Lung Disease
Hanci P et al. Respiratory abnormalities and adverse effects of treatment regimen may put patients with interstitial lung disease (ILD) at a risk of developing sleep disordered breathing. A study was conducted to find out the relationship between the quality of sleep, sleep disordered breathing and incidence of obstructive sleep apnea in patients with ILD. This study involved fifty two patients with ILD. Pittsburg Sleep Quality Index (PSQI) and Epworth Sleepiness Score (ESS) were applied to the study. The patients underwent spirometry and CO diffusion tests. Patients having an ESS score >10 were advised to undergo polysomnography. The results of polysomnography were compared with subjective parameters of sleep and sleep quality. Demographic characteristics, body mass index, immunosuppressive medication, spirometry and diffusion measurements, the subcomponents of PSQI and global score did not differ between the two groups. The results showed that the subjective sleep quality was poor in 44% of the patients. The PSQI and sub-components did not correlate with Apnea- Hypopnea Index (AHI), stage 1 latency, sleep efficiency and nocturnal desaturation. Night time hypoxemia was determined with severity of restriction, arousals and sleep efficiency. From the total study group, 70% of patients were diagnosed with obstructive sleep apnea (OSA). The AHI index showed negative correlation with parameters like the percentage of FEV1- FVC, sleep efficiency; which was observed during REM sleep in the supine position. The authors concluded that though patients with ILD do not suffer from daytime hypoxemia, but nocturnal hypoxemia can be a potential contributor of the apnea-hypoxemia episodes. Thus, daytime sleepiness, sleep quality and sleepiness scales should be considered as an important evaluation parameter in patients with ILD for determining sleep disordered breathing. P4024, presented at European Respiratory Society (ERS) conference 2013

ICS Can be Safely Withdrawn in Patients with Mild-Moderate COPD Patients

Rossi A et al. Inhaled corticosteroids (ICS) are known to be overprescribed in mild-moderate COPD and patients with infrequent exacerbations (< 2/yr). This study from Italy investigated if ICS could be safely withdrawn and continued only on bronchodilators in patients who did not qualify for them as per the guidelines. Based on their clinical judgement clinicians decided to either continue inhaled corticosteroids- long acting beta agonists (ICS/LABA) combinations or to withdraw ICS and continue patients with either the long acting beta agonist and/or long acting antimuscarinc. This was done in 914 patients with mild-moderate COPD and without frequent exacerbations on the first visit for the study. Patients were then evaluated after 6 months. There was no change in FEV1% predicted, exacerbation rate and the COPD Assessment Test scores in the study population after 6 months. These findings therefore prove that ICS can be safely withdrawn in patients with mild-moderate COPD & non-frequent exacerbators if they are maintained on long acting bronchodilators. P4144, presented at European Respiratory Society (ERS) conference 2013

Sustained Control In Severe Asthmatics: Is It Possible?

Bourdin A et al. Sustained control of severe asthma over a one year period even after using the best standard of care including non-pharmacological measures is possible or not, is still unclear. In this 2-year prospective study, 62 severe asthmatics after 1 year run-in period were enrolled. After confirming the asthma severity, systematic attention to psychological and therapeutic adherence questions was optimized through 6 visits, over the second year. For optimal control (ACQ always <2, no exacerbation and FEV1 always >85% best personal values) and acceptable control (ACQ always <3.5, one mild exacerbation tolerated with no hospitalisation and no emergency visit and FEV1 always >85% best personal values) at each visit, a composite control score was used. This control score had integrated the ACQ score, the exacerbation rate and the FEV1 value. Of the 62 asthmatics, 28% had sustained acceptable control whereas, 15% had optimal control. There was a significant reduction in the exacerbations, from 3 per year to 1 or less per year (p<0.001). Female gender and high FEV1 variations were independently associated with annual exacerbations over the year. At each visit, the ACQ score was the best predictor of subsequent exacerbations. Exacerbation rate was decreased efficiently after enrolling the severe asthmatics in the clinical trial but achieving sustained control is still a challenge over 1 year period. P4126, presented at European Respiratory Society (ERS) conference 2013

Platelet Count as a Marker of CAP Outcome

Martnez D et al. Abnormal platelet count (PC) has been associated with complications and increased mortality in hospitalized community-acquired pneumonia (CAP) patients.

The 12 months prospective multicenter and longitudinal study, evaluated the relation of PC at time of hospitalization, thrombocytosis compared with thrombocytopenia and normal platelet count with severity of disease and most frequent complications in hospitalized patients with CAP. The study included 1314 hospitalized adult patients with CAP. Patients with immunosuppression, active tuberculosis or hematological disease were excluded from the study. The groups were compared using 2, T student and logistic regression. 3% of the patients presented thrombocytopenia, 8% presented thrombocytosis and 89% had normal platelet count. The average of PC was 248923 SD 142952. Lower platelet counts were associated with an increase of disease severity by PSI or CURB65 (p=0,014, p=0,004 respectively). Patients with thrombocytopenia were noted to have severe sepsis (p< 0,001) and more frequent ICU admission (p= 0,011), whereas those with thrombocytosis presented more frequent respiratory complications such as empyema (p <0,001). No association was found between abnormal platelet count and increased mortality risk in the multivariable logistic regression model. The findings of the study conclude that an abnormal platelet count is linked with disease severity and more frequent complications in CAP patients. P4377, presented at European Respiratory Society (ERS) conference 2013

Single Agent Gemcitabine or Docetaxel in the Second-Line Therapy for NSCLC

Yurdakul A et al. Medical records of 57 non-small cell lung cancer (NSCLC) patients (55 male and 2 female) of mean age of 56.728.39 years were retrospectively evaluated to compare the efficacy and toxicity of gemcitabine versus docetaxel in the second-line setting. All patients received one prior a platinum-based therapy. 40 patient received docetaxel and 17 of received gemcitabine. The mean number of chemotherapy cycles was 4.63.0 in the docetaxel group and 6.84.0 cycles in the gemcitabine group. There was significant difference is overall response rates i.e. 8% and 12% for gemcitabine and docetaxel, respectively (p=0.02).The median time to progression and survival time were 8 and 22 months for gemcitabine and 5 and 21 months for docetaxel respectively. There was no difference in overall survival and incidence of the adverse effects between two groups. Compared with docetaxel treatment in the second-line setting for patients with NSCLC, treatment with gemcitabine demonstrated clinically equivalent efficacy and safety profile. P4492, presented at European Respiratory Society (ERS) conference 2013

Chronic Cough, Asthma-Like Symptoms and Normal Spirometry: Is It Asthma?

Alisauskas A et al. The most frequent symptom for which patients seek medical attention is cough. The most common causes of chronic cough are asthma, gastroesophageal reflux (GERD) disease and upper airways disease. The present study aimed to evaluate whether patients with chronic cough, normal spirometry and asthma-like symptoms always have asthma. Outpatients (n=111, 37 male and 74 female, aged 48.7214.96) referred for evaluation of asthma were investigated using the medical records. Patients with chronic cough (more than 8 weeks), asthma-like symptoms, normal spirometry and methacholine challenge test for confirming asthma diagnosis were included. 10.2% patients had positive methacholine test, 21.6% doubtful and 67.6% showed negative methacholine challenge test. Only 24.3% patients were diagnosed with asthma. GERD 36.0%, upper airways disease 13.5%, chronic bronchitis 10.8%, post infection cough 3.6% were other diagnosis and 10.8% with no diagnosis. In patients with chronic cough and asthma-like symptoms, only one third had asthma. With these symptoms and negative methacholine challenge test other patients had different diagnosis. This can also be associated with cough hypersensitivity syndrome (a new clinical entity which possibly mimics pulmonary diseases). P4179, presented at European Respiratory Society (ERS) conference 2013

Non-tuberculous Mycobacterial Lung Disease - Is Low Body Fat The Cause?

Lee S et al. In view with the increasing immunocompetent patientswith nontuberculous mycobacterial lung disease (NTMLD), without any other previous lung disease; a study based on the hypotheses that a leaner individual with low body fat is a predisposing factor of NTMLD, was conducted. A total of 148 patients with NTMLD (median age 62 years) were enrolled in this study. The parameter evaluated during the study were, the extent of lung involvement on chest computed tomography (CT) based on the lobar distribution and subcutaneous fat mass (SFM) using cross-sectional CT scans at mid pole level of left kidney. A control group of 142 patients with negative chest CT finding was also studied. The SFM between the control and NTMLD was compared and relationship between SFM and disease severity according to the extent of NTMLD were evaluated. It was found that the NTMLD group had significantly lower SFM (39.3) than the control group (53.0). 70.9% of the patients were classified into nodular bronchiectatic group. In NTMLD, patients with fibrocavitary type showed lower SFM than patient with nodular bronchiectatic type (23.6 vs. 41.9). There was no significant difference in SFM between localized (3 lobes) disease and extensive (>3 lobes) disease (43.5 vs. 35.9). In nodular bronchiectatic type, the difference in SFM according to disease severity was not

shown (localized vs. extensive, 19.3 vs. 26.7). The authors of the study concluded that patients with NTMLD had low body fat, which was measured by SFM in chest CT. Thus, it is shown that low body fat appears to be responsible for host susceptibility to NTMLD. P4368, presented at European Respiratory Society (ERS) conference 2013

Altered Respiratory Status Observed In More Than 80% of Females Working In the Manual Brick Making Units in India
Sett et al. Workers from low socio-economic class are usually employed on a contract basis in brick manufacturing industries. Occupational exposure to dust, from mud, sand, coal dust (used as fuel to bake the bricks) and chimney smoke may predispose them to health hazards. Hence, Sett and Sahu sought to assess the respiratory status of the female brick field workers exposed to the field dust during work. The study population comprised of a test group (216 female workers engaged in manual brick manufacturing units) and a control group (209 female students of the same age group). The parameters assessed included the Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1) and as a percentage of FVC (FEV1%); forced expiratory flows of four intervals (FEF25%, 50%, 75%; 25-75%), maximum voluntary ventilation (MVV) and Peak Expiratory Flow Rate (PEFR). Significant differences in the lung function values were observed among the two groups. Alterations in the respiratory status were seen in more than 80% of the test group compared to 22% of the control group. Age was not a risk factor for the altered lung function as the subjects were young. The study concluded that changes in the lung function in the test group could be accredited to exposure to dusty environment. This exposure was likely to irritate the upper respiratory mucosa and lead to hypertrophy of mucosal cells and form mucus plugs, resulting in airflow obstruction. P990, presented at European Respiratory Society (ERS) conference 2013

Similar Systemic Exposure Profile Seen In Two Mometasone Furoate Nasal Spray Formulations
Phatak M et al. Mometasone furoate (MF) is a topical glucocorticosteroid with local anti-inflammatory properties, withhigh potency, available for the treatment of the nasal symptoms in seasonal and perennial allergic rhinitis. A randomized, open label, crossover study was conducted in 48 healthy adult male subjects, in order to determine the pharmacokinetic profile of two MF nasal spray formulations. The study evaluated the total systemic exposure of MF when administered as a nasal spray between a test product (MF aqueous nasal spray suspension 50 mcg/actuation of Cipla Ltd.) and compared it with the reference product. The subjects received a single-dose of MF, on two treatment days, separated by a washout period of 8 days. They were given a total dose of 400 mcg in each period 8 sprays (4 sprays in each nostril) under fasting conditions. Out of the total 48 subjects, 45 completed the study. The final pharmacokinetic evaluations were interpreted by analysis of plasma samples from these subjects. The 90% confidence intervals for ratios (%) of the least square mean of the test and reference product of log transformed data for Cmax, AUC 0-t and AUC 0- inf for MF were 85.61 to 103.17, 96.17 to 115.87 and 94.12 to 112.18 respectively. The plasma concentration- time profile following administration of the test product was similar to that of the reference product. Thus, the two MF nasal sprays i.e. test and reference product were shown to have similar systemic bioavailablity. No serious adverse events were reported during the study duration and both the products were well tolerated after administration of single dose of 400 mcg. Thus, the test product obtained from Cipla Ltd. was found to have similar systemic exposure to that of the reference product. P913, presented at European Respiratory Society (ERS) conference 2013

Metabolomic Profile: A New Approach to Tuberculosis Diagnosis

M. Serra et al. Metabolomics study by using urine samples has demonstrated to be a promising tool in the diagnosis of several respiratory infections. However, metabolomic studies have not been explored for the diagnosis of tuberculosis (TB) with such samples. The metabolomic profile in urine samples through Nuclear Magnetic Ressonance (NMR) was assessed.In this study, metabolic changes due to tuberculosis were detected along with identification of urine biomarkers helpful in diagnosing tuberculosis. A urine sample was collected from 147 individuals classified in three groups: healthy controls (n=31), latently infected individuals (n=18) and TB patients (n=98). A urine sample was analysed by proton NMR spectroscopy. A one-dimensional spectrum was obtained for each urine sample and data were analysed with MestreNova software Afterwards, Metabonomics was used to perform a statistical multivariate analysis to identify spectrum regions candidates to contain biomarkers for TB. The identification of these metabolites was done with Chenomx software, which requires a two-dimensional NMR analysis from urine.

The results of the study showed that there is a statistical significance between NMR spectrum from TB patients and other studied group. A total of 20 metabolites were identified when analysis of the spectral region was done. Thus, the difference was noticed in the urine metabolic pattern in TB patients from that of the non-TB patients and the results of the study suggested that the metabolomic profile in urine is a potential tool for TB diagnosis. P511, presented at European Respiratory Society (ERS) conference 2013

Long Acting Bronchodilators Exhibit a Similar Cardiovascular Safety Profile in COPD

Vogelmeier et al. Long-acting bronchodilators are recommended by guidelines as the preferred therapeutic options for maintenance treatment of COPD. Consequently, the cardiovascular safety of these treatments is of importance. Hence, Vogelmeier and colleagues assessed the cardiovascular safety of tiotropium and the long-acting 2-agonist salmeterol in a pooled analysis of studies conducted in more than 8000 patients with COPD. This pooled analysis evaluated 4 double-blind, randomized, parallel-group studies comparing the cardiovascular adverse event profile of tiotropium (n=4437) via dry powder inhaler (DPI) and salmeterol (n=4399) by the metered dose inhaler (MDI) in 8836 patients. At baseline, 25.3% had a cardiac disorder and slightly more than 50% were using CV medication. The incidence rates (per 100 patient years) of serious adverse cardiovascular events and mortality events are given in the table. Incidence rates in Tiotropium group (n=4437) All cardiac events Cardiac arrhythmia Other ischemic heart diseases Myocardial infarction Stroke All-cause mortality fatal major adverse cardiac events (MACE) including death unknown 2.65 0.54 0.74 0.67 0.38 1.74 0.72 Incidence rates in Salmeterol group (n=4399) 2.57 0.63 0.63 0.50 0.42 2.08 0.92 Rate ratio (95% CI)

1.03 (0.78, 1.36) 0.85 (0.47, 1.53) 1.18 (0.68, 2.02) 1.33 (0.74, 2.41) 0.91 (0.45, 1.85) 0.84 (0.61, 1.16) 0.78 (0.47, 1.28)

The pooled analysis concluded that tiotropium DPI once daily showed a comparable CV safety profile to salmeterol MDI in patients with COPD. P753, presented at European Respiratory Society (ERS) conference 2013

Spirometry Use has Improved in India

Vanjare N. et al In India, various initiatives have been taken to improve the use of spirometry among physicians. Whether it has been improved over the past 7 years was the aim of our study. A one page questionnaire that captured the details about the spirometry use in their clinic was completed by doctors (chest physicians-CPs, paediatricians- Ps, general practitioners-GPs and physicians- GenPs), randomly selected across the country. The responses were compared with the similar study conducted in the year 2005, in India. Among 4100 randomly selected doctors, 1714 and 2197 physicians had responded in 2005 and 2013. Physicians who used spirometry in 2005 reported were CPs 55%, GenPs 20%, GPs 10%, Ps 5% whereas in the year 2013, the spirometry use reported was CPs 72% (p<0.0001), GenPs 26.3% (p=0.01), GPs 12% (p=0.62), Ps 16.2% (p<0.001). The use of spirometry has been significantly improved in India among chest physicians, general physicians and paediatricians with a small change among general practitioners. P271, presented at European Respiratory Society (ERS) conference 2013

Characterizing Asthma-COPD Overlap in the Elderly

Milanese M et al. Asthma- Chronic Obstructive Pulmonary Disease (COPD) overlap in the elderly is a known entity and yet there is no defined approach to its management. Hence the Milanese et al from Italy performed a 6-month observational study called ELSA (Elderly Subjects with Asthma).

The study included 320 elderly patients ( 65 years of age) with asthma and asthma-COPD overlap. Out of 320, 232 were only asthmatic whereas 88 were with asthma-COPD overlap. Presence chronic bronchitis and/or impaired CO diffusion along with asthma was considered as asthma-COPD overlap. The following were the salient findings from the study. As compared to asthmatic patients with asthma-COPD overlap-

were significantly less controlled as measured by the Asthma Control Test scores (18.44 versus 204, p< 0.05). were significantly more at risk for 2 severe asthma exacerbations (18% versus 6%, p<0.05). used inhaled corticosteroids/long acting beta2 agonist (ICS/LABA) less frequently (58% versus 74%)

Additionally, the asthma-COPD overlap group had significantly more ex-smokers as compared to only asthma group (37% versus 21%, p< 0.05). 355, presented at European Respiratory Society (ERS) conference 2013

Acute Infections with M.pneumoniae and Cl.pneumoniae in Children with Uncontrolled Asthma
Ilyenkova N et al. The role of bacteria like Mycoplasma pneumoniae (M.pneumoniae) and Chlamydia pneumoniae(Cl.pneumoniae) in the progression of asthma is widely explored. This study was conducted with the objective of identifying the important serological markers caused due to infection withM.pneumoniae and Cl.pneumoniae, in children with asthma. The study population included 62 children in the age of 6- 14 years. They were divided into 3 groups as: 32% children with uncontrolled run of asthma, 32% children with controlled run of asthma and the remainder 36% healthy children as control group. Enzyme linked immunosorbent assay (ELISA) tests were used to analyse specific immunoglobulins (IgA, IgM, IgG) againstM.pneumoniae and Cl.pneumoniae from the serum samples of these children. Statistical differences in the quality characteristics were analysed using the Fischer Exact test. On analyzing the results, the ratio of antibodies to M. pneumoniae showed, that in the group of children with uncontrolled run of asthma, the combination of the three specific antibodies; IgM(+), IgA (+/-),IgG (+/-) was observed in 75% (95%CI= 51-91) children, as compared to 25% (95%CI=8-49) of children with a controlled run of asthma, and 13% (95%CI= 3-35) of children in the control group (p1,2= 0.004). Similarly, on analyzing the ratio of antibodies to Cl. pneumoniae, the group of children with uncontrolled run of asthma showed a combination of IgM(+), IgA (+/-), IgG (+/-) in 65% (95%CI= 41-84) children, as compared to 25% (95%CI=0-24) of children with a controlled run of asthma, but was not observed in the children in the control group (p1,2= 0.02). Hence, the study findings suggested that Mycoplasma and Chlamydia are potential organisms causing acute infection in children with uncontrolled bronchial asthma and the frequency of detecting specific serological markers for M.pneumoniae is 75% and that of Cl. pneumoniae is 65%. P1136, presented at European Respiratory Society (ERS) conference 2013

Beware: Even E-Cigarettes are Harmful!

Vakali S et al. Various studies presented at ERS have shown the hazardous effects of an e-cigarette. E-cigarettes are quite popular among the smokers as they are considered a safer alternative to smoking tobacco cigarettes. However there has been a controversy about the safety of these electronic cigarettes. A study was designed to assess the acute effect of smoking an e-cigarette in 62 participants (Mean age 45.43 years). Of these 16 smokers had COPD while 12 smokers were suffering from asthma. The findings of the study were:

Sore throat and cough were reported in 90% asthmatics and 63% COPD patients Significant increase in heart rate (P<0.05) with palpitations Significant decrease in SpO2 (P<0.05) Significant increase in exhaled CO (P<0.05)

Another study was conducted to assess the effect of single e-cigarette use in 54 subjects (21 never smokers and 33 healthy smokers). Subjects receive e-cigarette with or without nicotine. Subjects who received e-cigarette containing nicotine reported more sore throat, cough, palpitations, increase in heart rate and increase in airway temperature (P=0.037) while those who received e-cigarette without any nicotine reported more dizziness and greater decrease in FeNO (P<0.05). All the subjects were detected with an increase in exhaled CO. Thus it can be seen that, e-cigarettes cause harmful health effects in smokers. Even the single use of an e-cigarette increased heart rate, cough, sore throat etc. Hence various claims that electronic cigarettes are safe and help smokers quit need to be backed up by clinical studies and toxicity analyses and should operate within the appropriate regulatory framework. P1053 and P1055, presented at European Respiratory Society (ERS) conference 2013

Salmeterol Fluticasone BAI as Good as pMDI with High Patient Preference

Gogtay et al.

Salmeterol Fluticasone combination (SFC) given through a breath actuated inhaler (BAI) was found to be as good as the SFC given through a pressurized metered dose inhaler (pMDI). The BAI device showed a much higher patient preference as compared to the conventional pMDI. The aim of this study was to compare the efficacy and safety of SFC given through pressurized pMDI with a BAI in 150 moderate to severe asthmatics. This was a double-blind, double-dummy, prospective, active-control, parallel group, 12 weeks study. After the 12 weeks of treatment, morning PEFR improved significantly in both the groups.

Change in evening PEFR at week 2 (26.9 L/min vs. 16.8 L/min) & week 4 (32.87 L/min vs. 21.9 L/min) was greater in the BAI group and difference was statistically significant (p<0.05). FEV1, FVC, day & night time symptoms scores and rescue medication usage were similar in both the groups. There were no differences in frequencies of adverse events. In the usability assessment, around 75% of the participants preferred BAI over pMDI. Thus it was concluded that SFC when given in the BAI device demonstrated non-inferiority in terms of efficacy and safety in comparison to pMDI in moderate-to-severe asthmatics. BAI was also the preferred device as compared to the pMDI. P703, presented at European Respiratory Society (ERS) conference 2013

Efficacy of Fluticasone/Formoterol Combination versus Fluticasone

Papi A et al. For asthma management, combination of fluticasone/formoterol in a single inhaler has been approved as maintenance treatment. In the present study, the efficacy of the combination was assessed versus fluticasone alone in patients previously receiving inhaled corticosteroid therapy. In patients with asthma (aged 12 years), data from 5 randomized studies were pooled. Patients (n=1055) were treated for 8 -12 weeks with fluticasone/formoterol (100/10, 250/10 or 500/20 mcg, b.i.d) or fluticasone alone (100, 250 or 500 mcg, b.i.d). In fluticasone/formoterol group vs fluticasone, the change in the pre-dose FEV1 was 0.205 vs 0.157, 2 hr post-dose FEV1 was 0.377 vs 0.231, percentage asthma control days were 48.6% vs 40.1% and percentage of patients with exacerbations were 29.9 vs 36.6. The combination of fluticasone/formoterol significantly (p<0.05) improved lung function, asthma control days (i.e. no symptoms no rescue medication use and no nocturnal awakenings) with lower incidence of exacerbations compared to fluticasone. P704, presented at European Respiratory Society (ERS) conference 2013

Right Middle Lobe Can Be Safely Treated With Bronchial Thermoplasty

Wiese T et al. A unique poster presented at ERS revealed that the right middle lobe can be safely treated with Bronchial Thermoplastly (BT). BT is a FDA approved method to treat severe asthma in adults. Various research studies have shown that patients who undergo this therapy have improved quality of life, decreased exacerbations, and decreased requirement of medications. However these studies on BT did not included treatment of the right middle lobe. Also there is a concern that BT may cause inflammation, edema, or stenosis of the airway.

Hence, the right middle lobe of the lungs was not treated as it is the most susceptible to damage due to its unique anatomical features. Till date, BT was not done on right middle lobe and this study aimed to perform it. The study consisted of retrospective review of the institutions experience with BT of the right middle lobe. The investigators reviewed the data of 10 BT patients treated over 8 months time period. At the time of the first procedure, the right middle lobe was treated with the right lower lobe. After 6 weeks, direct examination of the right middle lobe showed no airway narrowing by stenosis or bronchomalacia in any of the 10 patients. Further after 6 months, none of the patient experienced problems with stenosis or malacia of the right middle lobe. There was no significant change in FEV1 and patients had similar improvements in quality of life scores as compared to previous studies (1.39 vs 1.35). Thus it can be concluded that the right middle lobe of lung can be safely treated with BT. Follow-up for a longer period is needed to determine if there may be any additional benefits of including the right middle lobe. P2299, presented at European Respiratory Society (ERS) conference 2013

Linezolid in the Treatment of Patients with MDR TB and XDR TB

CherenkoS et al. Linezolid plays an increasingly important role in the treatment of multidrug-resistant tuberculosis (MDR-TB). In one observational study, the efficacy and safety of linezolid treatment regimens for the MDR TB/XDR treatment was analyzed.In this study,30 MDR TB and 27 XDR TB patients were included.There were 24 menand 33 women with the mean age of 34.51.3 years. Depending upon the sputum conversion and adverse effects, linezolid was given at a dose of 0.6 g once daily for 3-6 months and the results of treatment were assessed by the end of the intensive phase of treatment. Sputum conversion (smear and culture) were seen in 91.2% patients during 3.20.2months; 88.9% patients with XDR resistance and in 93.3% patients with advanced MDR without XDR resistance. Adverse reactions were observed in 54.4% patients; in the most cases were dyspeptic adverse reactions (35.1%), neurological (21.1%), hepatotoxicity 12.3% patients. Adverse reactions from linezolid were seen in 7 % patients (hematology, diarrhea). Thus, results of the study concluded that the treatment with linezolid were high and equal for patients with XDR TB and advanced MDR TB (including ofloxacin resistance or aminoglycoside resistance). Linezolid in a dose of 0.6 g per day was found to be efficacious and had good tolerability with adverse reactions occurring in few cases (7%). P2818, presented at European Respiratory Society (ERS) conference 2013

Bronchoscopic Hot Saline Ablation (BHSA): A Different Approach for Emphysema

Stav D et al. Lung volume reduction is a procedure which has been in focus recently for treatment of emphysema. In the present study, a group of researchers from Israel evaluated the feasibility and safety of bronchoscopic lung volume reduction independent of collateral ventilation in six patients (male and female, mean age 61 years) with severe heterogenous emphysema in the upper lobes. These patients underwent unilateral bronchoscopic instillation of 130 ml hot saline (50C) in the upper lobes with an intention to induce an inflammatory airway and parenchymal response which consequently resulted in fibrosis. This consequent fibrosis would result in lung volume reduction. At baseline, the forced expiratory volume in 1 second (FEV1) was 32% of the predicted (0.77 0.17 L), the residual volume was 219% of predicted (4.1 0.9 L) and the gas transfer was 34% of predicted (7.8 2.2) of the patients. After the procedure, there were serious adverse events in 5 out of 6 treated patients. These serious adverse events included probable bacterial pneumonia and in 2 patients there were exacerbations of the airway disease. There were no important changes in FEV1 or residual volume during 6 months of follow up but the gas transfer improved to 38% predicted (from 16% to 9% 2.1%). When analysed for symptoms using the COPD assessment test (CAT), the scores decreased from 22 to 12 indicating improvement in symptoms. The researchers concluded that their preliminary data suggest that BHSA therapy is a feasible and potentially efficacious option with an acceptable safety profile for severe emphysema in the upper lobes. P2280, presented at European Respiratory Society (ERS) conference 2013

Real-Life Investigation of Prescriptions Following Initial COPD Diagnosis

Jones R et al. Chronic obstructive pulmonary disease (COPD) treatment suggested by guidelines is first with bronchodilators and then with inhaled corticosteroids (ICS). However, according to previous research ICS has been overused in the COPD management. This real-life study investigated the prescriptions of COPD therapies using the Optimum Patient Care Research Database (OPCRD). Data of one year pre and 2 years post diagnosis, supportive of COPD was analysed in patients aged 40 years, with severity of lung function defined by FEV1 % predicted. At the initial diagnosis, patients (n=20154) receiving medications were described as ICS, ICS + long acting beta2- agonist (LABA), ICS + LABA + long acting muscarinic antagonist (LAMA), ICS + LAMA, LABA, LABA + LAMA, LAMA, based on lung function severity. Patients with no treatment prior to their initial COPD diagnosis were referred as 'none'.

Regardless of their lung function severity, patients appear to be inappropriately prescribed ICS at their initial COPD diagnosis. Also, a significant percentage of patients despite of severe loss of function were prescribed no treatment. P2391, presented at European Respiratory Society (ERS) conference 2013

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