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The aim was to compare the effect of diaphragmatic breathing exercise (DBE), flow- (FIS) and volume-oriented incentive spirometry (VIS) on pulmonary function- (PFT), functional capacity-6-Minute Walk Test (6 MWT) and Functional Difficulties Questionnaire (FDQ) in subjects undergoing Coronary Artery Bypass Graft surgery (CABG). The purpose of incorporating pulmonary ventilator regimes is to improve ventilation and avoid post-operative pulmonary complications. CABG patients (n = 72) were allocated to FIS, VIS and DBE groups (n = 24 each) by block randomization. Preoperative and postoperative values for PFT were taken until day 7 for all three groups. On 7th postoperative day, 6 MWT and FDQ was analyzed using ANOVA and post-hoc analysis. PFT values were found to be decreased on postoperative day 1(Forced Vital Capacity (FVC) = FIS group—65%, VIS group—47%, DBE group—68%) compared to preoperative day (p < 0.001). PFT values for all 3 groups recovered until postoperative day 7 (FVC = FIS group—67%, VIS group—95%, DBE group—59%) but was found to reach the baseline in VIS group (p < 0.001). When compared between 3 groups, statistically significant improvement was observed in VIS group (p < 0.001) in 6 MWT and FDQ assessment. In conclusion, VIS was proven to be more beneficial in improving the pulmonary function (FVC), functional capacity and FDQ when compared to FIS and DBE.

The purpose of this study was to assess the accuracy of the Cosmed K5 portable metabolic system dynamic mixing chamber (MC) and breath-by-breath (BxB) modes against the criterion Douglas bag (DB) method. Fifteen participants (mean age±SD, 30.6±7.4 yrs) had their metabolic variables measured at rest and during cycling at 50, 100, 150, 200, and 250W. During each stage, participants were connected to the first respiratory gas collection method (randomized) for the first four minutes to reach steady state, followed by 3-min (or 5-min for DB) collection periods for the resting condition, and 2-min collection periods for all cycling intensities. Collection periods for the second and third methods were preceded by a washout of 1-3 min. Repeated measures ANOVAs were used to compare metabolic variables measured by each method, for seated rest and each cycling work rate. For ventilation (VE) and oxygen uptake (VO2), the K5 MC and BxB modes were within 2.1 l/min (VE) and 0.08 l/min (VO2) of the DB (p≥0.05). Compared to DB values, carbon dioxide production (VCO2) was significantly underestimated by the K5 BxB mode at work rates ≥150W by 0.12-0.31 l/min (p<0.05). K5 MC and BxB respiratory exchange ratio values were significantly lower than DB at cycling work rates ≥100W by 0.03-0.08 (p<0.05). Compared to the DB method, the K5 MC and BxB modes are acceptable for measuring VE and VO2 across a wide range of cycling intensities. Both K5 modes provided comparable values to each other.

Poor adherence to asthma controller medications results in poor treatment outcomes. To compare controller medication adherence and clinical outcomes in 612 adults with poorly controlled asthma randomized to one of two different treatment decision-making models or to usual care. In shared decision making (SDM), nonphysician clinicians and patients negotiated a treatment regimen that accommodated patient goals and preferences. In clinician decision making, treatment was prescribed without specifically eliciting patient goals/preferences. The otherwise identical intervention protocols both provided asthma education and involved two in-person and three brief phone encounters. Refill adherence was measured using continuous medication acquisition (CMA) indices-the total days' supply acquired per year divided by 365 days. Cumulative controller medication dose was measured in beclomethasone canister equivalents. In follow-up Year 1, compared with usual care, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.46; P < 0.0001) and long-acting beta-agonist adherence (CMA, 0.51 vs. 0.40; P = 0.0225); higher cumulative controller medication dose (canister equivalent, 10.9 vs. 5.2; P < 0.0001); significantly better clinical outcomes (asthma-related quality of life, health care use, rescue medication use, asthma control, and lung function). In Year 2, compared with usual care, SDM resulted in significantly lower rescue medication use, the sole clinical outcome available for that year. Compared with clinician decision making, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.59; P = 0.03) and long-acting beta-agonist adherence (CMA, 0.51 vs. 0.41; P = 0.0143); higher cumulative controller dose (CMA, 10.9 vs. 9.1; P = 0.005); and quantitatively, but not significantly, better outcomes on all clinical measures. Negotiating patients' treatment decisions significantly improves adherence to asthma pharmacotherapy and clinical outcomes. Clinical trials registered with www.clinicaltrials.gov (NCT00217945 and NCT00149526).

Exposure to biomass smoke has been related to adverse health effects. In Mexico, one household in four still cooks with biomass fuel, but there has been no evaluation of the health impact of reducing indoor air pollution. To evaluate the health impact of the introduction of an improved biomass stove (Patsari; Interdisciplinary Group for Appropriate Rural Technology [GIRA], Patzcuaro, Mexico) in Mexican women. A randomized controlled trial was conducted in the Central Mexican state of Michoacán. Households were randomized to receive the Patsari stove or keep their traditional open fire. A total of 552 women were followed with monthly visits over 10 months to assess stove use, inquire about respiratory and other symptoms, and obtain lung function measurements. Statistical analysis was conducted using longitudinal models. Adherence to the intervention was low (50%). Women who reported using the Patsari stove most of the time compared with those using the open fire had significantly lower risk of respiratory symptoms (relative risk [RR], 0.77; 95% confidence interval [CI], 0.62-0.95 for cough and RR, 0.29; 95% CI, 0.11-0.77 for wheezing) adjusted for confounders. Similar results were found for other respiratory symptoms as well as for eye discomfort, headache, and back pain. Actual use of the Patsari stove was associated with a lower FEV(1) decline (31 ml) compared with the open fire use (62 ml) over 1 year of follow-up (P = 0.012) for women 20 years of age and older, adjusting for confounders. The use of the Patsari stove was significantly associated with a reduction of symptoms and of lung function decline comparable to smoking cessation.

Background Systemic sclerosis (SSc) is a rare connective tissue disease associated with rapidly evolving interstitial lung disease (ILD), driving its mortality. Specific imaging-based biomarkers associated with the evolution of lung disease are needed to help predict and quantify ILD. Methods We evaluated the potential of an automated ILD quantification system (icolung ® ) from chest CT scans, to help in quantification and prediction of ILD progression in SSc-ILD. We used a retrospective cohort of 75 SSc-ILD patients to evaluate the potential of the AI-based quantification tool and to correlate image-based quantification with pulmonary function tests and their evolution over time. Results We evaluated a group of 75 patients suffering from SSc-ILD, either limited or diffuse, of whom 30 presented progressive pulmonary fibrosis (PPF). The patients presenting PPF exhibited more extensive lesions (in % of total lung volume (TLV)) based on image analysis than those without PPF: 3.93 (0.36–8.12)* vs. 0.59 (0.09–3.53) respectively, whereas pulmonary functional test showed a reduction in Force Vital Capacity (FVC)(pred%) in patients with PPF compared to the others : 77 ± 20% vs. 87 ± 19% ( p  < 0.05). Modifications of FVC and diffusing capacity of the lungs for carbon monoxide (DLCO) over time were correlated with longitudinal radiological ILD modifications ( r =-0.40, p  < 0.01; r =-0.40, p  < 0.01 respectively). Conclusion AI-based automatic quantification of lesions from chest-CT images in SSc-ILD is correlated with physiological parameters and can help in disease evaluation. Further clinical multicentric validation is necessary in order to confirm its potential in the prediction of patient’s outcome and in treatment management.

Background Chronic obstructive pulmonary disease (COPD) is a complex condition with pulmonary and extra-pulmonary manifestations. This study describes the heterogeneity of COPD in a large and well characterised and controlled COPD cohort (ECLIPSE). Methods We studied 2164 clinically stable COPD patients, 337 smokers with normal lung function and 245 never smokers. In these individuals, we measured clinical parameters, nutritional status, spirometry, exercise tolerance, and amount of emphysema by computed tomography. Results COPD patients were slightly older than controls and had more pack years of smoking than smokers with normal lung function. Co-morbidities were more prevalent in COPD patients than in controls, and occurred to the same extent irrespective of the GOLD stage. The severity of airflow limitation in COPD patients was poorly related to the degree of breathlessness, health status, presence of co-morbidity, exercise capacity and number of exacerbations reported in the year before the study. The distribution of these variables within each GOLD stage was wide. Even in subjects with severe airflow obstruction, a substantial proportion did not report symptoms, exacerbations or exercise limitation. The amount of emphysema increased with GOLD severity. The prevalence of bronchiectasis was low (4%) but also increased with GOLD stage. Some gender differences were also identified. Conclusions The clinical manifestations of COPD are highly variable and the degree of airflow limitation does not capture the heterogeneity of the disease.

The effectiveness and safety of aztreonam lysine for inhalation (AZLI) in patients with cystic fibrosis (CF) on maintenance treatment for Pseudomonas aeruginosa (PA) airway infection was evaluated in this randomized, double-blind, placebo-controlled study. To evaluate the safety and efficacy of inhaled aztreonam lysine in controlling PA infection in patients with CF. After randomization and a 28-day course of tobramycin inhalation solution (TIS), patients (n = 211; > or =6 yr; > or =3 TIS courses within previous year; FEV(1) > or = 25% and < or =75% predicted values) were treated with 75 mg AZLI or placebo, twice or three times daily for 28 days, then monitored for 56 days. The primary efficacy endpoint was time to need for additional inhaled or intravenous antipseudomonal antibiotics. Secondary endpoints included changes in respiratory symptoms (CF Questionnaire-Revised [CFQ-R] Respiratory Scale), pulmonary function (FEV(1)), and sputum PA density. Adverse events and minimum inhibitory concentrations of aztreonam for PA were monitored. AZLI treatment increased median time to need for additional antipseudomonal antibiotics for symptoms of pulmonary exacerbation by 21 days, compared with placebo (AZLI, 92 d; placebo, 71 d; P = 0.007). AZLI improved mean CFQ-R respiratory scores (5.01 points, P = 0.02), FEV(1) (6.3%, P = 0.001), and sputum PA density (-0.66 log(10) cfu/g, P = 0.006) compared with placebo; no AZLI dose-response was observed. Adverse events reported for AZLI and placebo were comparable and consistent with CF lung disease. Susceptibility of PA to aztreonam at baseline and end of therapy were similar. AZLI was effective in patients with CF using frequent TIS therapy. AZLI delayed time to need for inhaled or intravenous antipseudomonal antibiotics, improved respiratory symptoms and pulmonary function, and was well tolerated. Clinical trial registered with www.clinicaltrials.gov (NCT 00104520).

Non-invasive ventilation (NIV) is an effective form of treatment in patients with obesity hypoventilation syndrome (OHS) who have concomitant severe obstructive sleep apnoea (OSA). However, there is a paucity of evidence on the efficacy of NIV in patients with OHS without severe OSA. We performed a multicentre randomised clinical trial to determine the comparative efficacy of NIV versus lifestyle modification (control group) using daytime arterial carbon dioxide tension (PaCO2) as the main outcome measure. Between May 2009 and December 2014 we sequentially screened patients with OHS without severe OSA. Participants were randomised to NIV versus lifestyle modification and were followed for 2 months. Arterial blood gas parameters, clinical symptoms, health-related quality of life assessments, polysomnography, spirometry, 6-min walk distance test, blood pressure measurements and healthcare resource utilisation were evaluated. Statistical analysis was performed using intention-to-treat analysis. A total of 365 patients were screened of whom 58 were excluded. Severe OSA was present in 221 and the remaining 86 patients without severe OSA were randomised. NIV led to a significantly larger improvement in PaCO2 of -6 (95% CI -7.7 to -4.2) mm Hg versus -2.8 (95% CI -4.3 to -1.3) mm Hg, (p<0.001) and serum bicarbonate of -3.4 (95% CI -4.5 to -2.3) versus -1 (95% CI -1.7 to -0.2 95% CI)  mmol/L (p<0.001). PaCO2 change adjusted for NIV compliance did not further improve the inter-group statistical significance. Sleepiness, some health-related quality of life assessments and polysomnographic parameters improved significantly more with NIV than with lifestyle modification. Additionally, there was a tendency towards lower healthcare resource utilisation in the NIV group. NIV is more effective than lifestyle modification in improving daytime PaCO2, sleepiness and polysomnographic parameters. Long-term prospective studies are necessary to determine whether NIV reduces healthcare resource utilisation, cardiovascular events and mortality. NCT01405976; results.

Bronchiectasis is a chronic debilitating disease with few evidence-based long-term treatments. A randomized controlled trial assessing the efficacy of nebulized gentamicin therapy over 1 year in patients with non-cystic fibrosis bronchiectasis. Sixty-five patients were randomized to either twice-daily nebulized gentamicin, 80 mg, or nebulized 0.9% saline, for 12 months. All were reviewed at three-monthly intervals during treatment and at 3 months' follow-up. At each review the following were assessed: quantitative and qualitative sputum bacteriology; sputum purulence and 24-hour volume; FEV(1), FVC, and forced expiratory flow, midexpiratory phase; exercise capacity; Leicester Cough Questionnaire and St. George's Respiratory Questionnaire; and exacerbation frequency. Fifty-seven patients completed the study. At the end of 12 months' treatment, compared with the saline group, in the gentamicin group there was reduced sputum bacterial density with 30.8% eradication in those infected with Pseudomonas aeruginosa and 92.8% eradication in those infected with other pathogens; less sputum purulence (8.7% vs. 38.5%; P < 0.0001); greater exercise capacity (510 [350-690] m vs. 415 [267.5-530] m; P = 0.03); and fewer exacerbations (0 [0-1] vs. 1.5 [1-2]; P < 0.0001) with increased time to first exacerbation (120 [87-161.5] d vs. 61.5 [20.7-122.7] d; P = 0.02). The gentamicin group had greater improvements in Leicester Cough Questionnaire (81.4% vs. 20%; P < 0.01) and St. George's Respiratory Questionnaire (87.5% vs. 19.2%; P < 0.004) score. No differences were seen in 24-hour sputum volume, FEV(1), FVC, or forced expiratory flow, midexpiratory phase. No P. aeruginosa isolates developed resistance to gentamicin. At follow-up, all outcome measures were similar to baseline. Regular, long-term nebulized gentamicin is of significant benefit in non-cystic fibrosis bronchiectasis but treatment needs to be continuous for its ongoing efficacy. Clinical trial registered with www.clinicaltrials.gov (NCT 00749866).

Background: Chronic obstructive pulmonary disease (COPD) has become a leading cause of morbidity and mortality in China, with tobacco smoke, air pollution, and occupational biohazards being the major risk factors. Objectives: The REACH trial is a multicenter, prospective, randomized controlled trial undertaken in China to assess the safety and effectiveness of the Spiration® Valve System (SVS) compared to standard medical care in COPD patients with severe emphysema. Methods: Patients with severe airflow obstruction, hyperinflation, and severe dyspnea with interlobar fissure integrity were evaluated for enrollment. A total of 107 subjects were randomized in a 2: 1 allocation ratio to either the treatment group (SVS valves and medical management) or the control group (medical management alone). Results: The 3-month primary endpoint showed statistically significant improvement in forced expiratory volume in 1 s in the treatment group compared to the control group (0.104 ± 0.18 vs. 0.003 ± 0.15 L, p = 0.001), with the difference being durable through 6 months. Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL). Exercise function and quality of life measures improved in the treatment group, but showed a deterioration in the control group. The serious adverse event (SAE) rate was 33% in the treatment group and 24.2% in the control group. The predominance of SAEs were acute exacerbations of COPD in both groups. There was 1 death in the control group and no deaths in the treatment group. Conclusion: The SVS represents a novel approach for the treatment of severe emphysema with a clinically acceptable risk-benefit profile.