Relationship between FEV1 change and patient-reported outcomes in randomised trials of inhaled bronchodilators for stable COPD: a systematic review.

BACKGROUND: Interactions between spirometry and patient-reported outcomes in COPD are not well understood. This systematic review and study-level analysis investigated the relationship between changes in FEV1 and changes in health status with bronchodilator therapy. METHODS: Six databases (to October 2009) were searched to identify studies with long-acting bronchodilator therapy reporting FEV1 and health status, dyspnoea or exacerbations. Mean and standard deviations of treatment effects were extracted for each arm of each study. Relationships between changes in trough FEV1 and outcomes were assessed using correlations and random-effects regression modelling. The primary outcome was St George's Respiratory Questionnaire (SGRQ) total score. RESULTS: Thirty-six studies (≥ 3 months) were included. Twenty-two studies (23,654 patients) with 49 treatment arms each contributing one data point provided SGRQ data. Change in trough FEV1 and change in SGRQ total score were negatively correlated (r = -0.46, p < 0.001); greater increases in FEV1 were associated with greater reductions (improvements) in SGRQ. The correlation strengthened with increasing study duration from 3 to 12 months. Regression modelling indicated that 100 mL increase in FEV1 (change at which patients are more likely to report improvement) was associated with a statistically significant reduction in SGRQ of 2.5 (95% CI 1.9, 3.1), while a clinically relevant SGRQ change (4.0) was associated with 160.6 (95% CI 129.0, 211.6) mL increase in FEV1. The association between change in FEV1 and other patient-reported outcomes was generally weak. CONCLUSIONS: Our analyses indicate, at a study level, that improvement in mean trough FEV1 is associated with proportional improvements in health status

Lung volumes identify an at-risk group in persons with prolonged secondhand tobacco smoke exposure but without overt airflow obstruction.

IntroductionExposure to secondhand smoke (SHS) is associated with occult obstructive lung disease as evident by abnormal airflow indices representing small airway disease despite having preserved spirometry (normal forced expiratory volume in 1 s-to-forced vital capacity ratio, FEV1/FVC). The significance of lung volumes that reflect air trapping in the presence of preserved spirometry is unclear.MethodsTo investigate whether lung volumes representing air trapping could determine susceptibility to respiratory morbidity in people with SHS exposure but without spirometric chronic obstructive pulmonary disease, we examined a cohort of 256 subjects with prolonged occupational SHS exposure and preserved spirometry. We elicited symptom prevalence by structured questionnaires, examined functional capacity (maximum oxygen uptake, VO2max) by exercise testing, and estimated associations of those outcomes with air trapping (plethysmography-measured residual volume-to-total lung capacity ratio, RV/TLC), and progressive air trapping with exertion (increase in fraction of tidal breathing that is flow limited on expiration during exercise (per cent of expiratory flow limitation, %EFL)).ResultsRV/TLC was within the predicted normal limits, but was highly variable spanning 22%±13% and 16%±8% across the increments of FEV1/FVC and FEV1, respectively. Respiratory complaints were prevalent (50.4%) with the most common symptom being ≥2 episodes of cough per year (44.5%). Higher RV/TLC was associated with higher OR of reporting respiratory symptoms (n=256; r2=0.03; p=0.011) and lower VO2max (n=179; r2=0.47; p=0.013), and %EFL was negatively associated with VO2max (n=32; r2=0.40; p=0.017).ConclusionsIn those at risk for obstruction due to SHS exposure but with preserved spirometry, higher RV/TLC identifies a subgroup with increased respiratory symptoms and lower exercise capacity

Screening elite winter athletes for exercise induced asthma: A comparison of three challenge methods

The official published version can be obtained from the link below.Background: The reported prevalence of exercise induced asthma (EIA) in elite winter athletes ranges from 9% to 50%. Many elite winter athletes do not report symptoms of EIA. At present there is no gold standard test for EIA. Objective: To establish the efficacy of screening for EIA and examine the role of the eucapnic voluntary hyperventilation (EVH) challenge and laboratory based and sport specific exercise challenges in the evaluation of elite winter athletes. Methods: 14 athletes (mean (SD) age 22.6 (5.7) years, height 177.2 (7.0) cm, body mass 68.9 (16.9) kg) from the Great Britain short-track speed skating (n=10) and biathlon teams (n=4) were studied. Each athlete completed a laboratory based and sport specific exercise challenge as well as an EVH challenge, in randomised order. Results: All 14 athletes completed each challenge. Two had a previous history of asthma. Ten (including the two with a previous history) had a positive test to at least one of the challenges. Ten athletes had a positive response to EVH; of these, only three also had a positive response to the sport specific challenge. No athletes had a positive response to the laboratory based challenge. Conclusions: Elite athletes should be screened for EIA. EVH is a more sensitive challenge in asymptomatic athletes than sport specific and laboratory based challenges. If sporting governing bodies were to implement screening programmes to test athletes for EIA, EVH is the challenge of choice

Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: A randomized non-inferiority study

Background: Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg has been shown to improve lung function and health status, and reduce exacerbations, versus budesonide/formoterol in patients with chronic obstructive pulmonary disease (COPD). We evaluated the non-inferiority of single-inhaler FF/UMEC/VI versus FF/VI + UMEC using two inhalers. Methods: Eligible patients with COPD (aged ≥40 years; ≥1 moderate/severe exacerbation in the 12 months before screening) were randomized (1:1; stratified by the number of long-acting bronchodilators [0, 1 or 2] per day during run-in) to receive 24-week FF/UMEC/VI 100/62.5/25 μg and placebo or FF/VI 100/25 μg + UMEC 62.5 μg; all treatments/placebo were delivered using the ELLIPTA inhaler once-daily in the morning. Primary endpoint: change from baseline in trough forced expiratory volume in 1 s (FEV1) at Week 24. The non-inferiority margin for the lower 95% confidence limit was set at − 50 mL. Results: A total of 1055 patients (844 [80%] of whom were enrolled on combination maintenance therapy) were randomized to receive FF/UMEC/VI (n = 527) or FF/VI + UMEC (n = 528). Mean change from baseline in trough FEV1 at Week 24 was 113 mL (95% CI 91, 135) for FF/UMEC/VI and 95 mL (95% CI 72, 117) for FF/VI + UMEC; the between-treatment difference of 18 mL (95% CI -13, 50) confirmed FF/UMEC/VI’s was considered non-inferior to FF/ VI + UMEC. At Week 24, the proportion of responders based on St George’s Respiratory Questionnaire Total score was 50% (FF/UMEC/VI) and 51% (FF/VI + UMEC); the proportion of responders based on the Transitional Dyspnea Index focal score was similar (56% both groups). A similar proportion of patients experienced a moderate/severe exacerbation in the FF/UMEC/VI (24%) and FF/VI + UMEC (27%) groups; the hazard ratio for time to first moderate/ severe exacerbation with FF/UMEC/VI versus FF/VI + UMEC was 0.87 (95% CI 0.68, 1.12). The incidence of adverse events was comparable in both groups (48%); the incidence of serious adverse events was 10% (FF/UMEC/VI) and 11% (FF/VI + UMEC). Conclusions: Single-inhaler triple therapy (FF/UMEC/VI) is non-inferior to two inhalers (FF/VI + UMEC) on trough FEV1 change from baseline at 24 weeks. Results were similar on all other measures of efficacy, health-related quality of life, and safety. Trial registration: GSK study CTT200812; ClinicalTrials.gov NCT02729051 (submitted 31 March 2016)

Flow-volume curve analysis for predicting recurrence after endoscopic dilation of airway stenosis

The flow-volume curve is a simple test for diagnosing upper airway obstruction. We evaluated its use to predict recurrence in patients undergoing endoscopic dilation for treatment of benign upper airway stenosis

Correlation of Lipopolysaccharide Endotoxin Level in Cotton Dust with the Increase of TNFα Level and the Decline of Lung Function in Cotton Spinning Factory Workers

Lipopolysaccharide (LPS) endotoxin contained in cotton dust may cause airway inflammation and decline of lung function when inhaled, which eventually leads to respiratory symptoms. The objective of this research is to analyze the correlation of the exposure of LPS endotoxin in cotton dust with the increase of TNF&alpha; level and the decline of lung function after one day&rsquo;s work. This study applies analytical observation method and prospective cohort approach. Main participants of this study were the workers of a cotton spinning factory located in Tulangan District, Sidoarjo Regency, East Java Province. Sixteen samples from cotton factory were taken as study group, and twenty three samples from village administrators were taken as control group. Data collection involves several techniques: spirometry, laboratory test, and interview. Results showed that concentration of personal dust has a significant relationship with the decline of FVC, %FVC, FEV1, and %FEV1, with Pearson correlation test showing p&lt;0.05. LPS endotoxin in personal dust samples has a significant relationship with the increase of blood serum TNF&alpha; and the decline of FEV1 and %FEV1, with Pearson correlation test showing p&gt;0.05. The research concludes that the level of LPS endotoxin was strongly related to the increase of blood serum TNF&alpha; and the decline of lung function. Development of more effective preventive measures such as stronger enforcement of worker&rsquo;s health maintenance regulations and use of personal protective equipment is needed to ensure the best protection of cotton workers&rsquo; health

LABA/LAMA combinations versus LAMA monotherapy or LABA/ICS in COPD : a systematic review and meta-analysis

Acknowledgments The meta-analysis work was performed by Guruprasad Rao KS and Sharanbasappa Durg of Molecular Connections (P) Ltd, Bangalore, India, under the guidance of the manuscript authors and Novartis Pharma AG (Basel, Switzerland). Medical writing assistance was provided by Colette O’Sullivan, PhD, of Scriva Medical Communications Ltd, a professional medical writer funded by Novartis. Development of the manuscript was supported by Novartis Pharma AG (Basel, Switzerland). The authors received no compensation related to the development of the manuscript.Peer reviewedPublisher PD

Inhaled corticosteroids versus long-acting beta -agonists for chronic obstructive pulmonary disease (Review).

Long-acting beta(2)-agonists and inhaled corticosteroids can be used as maintenance therapy by patients with moderate to severe chronic obstructive pulmonary disease. These interventions are often taken together in a combination inhaler. However, the relative added value of the two individual components is unclear