The European respiratory journal : official journal of the European Society for Clinical Respiratory Physiology
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Randomized Controlled Trial Multicenter Study
A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations.
Combination inhalers containing corticosteroids and long-acting β-agonists are used to reduce exacerbation rates in patients with severe chronic obstructive pulmonary disease (COPD). The FORWARD (Foster 48-week Trial to Reduce Exacerbations in COPD) clinical trial in severe COPD patients is a comparison of extrafine beclomethasone dipropionate and formoterol in a combination inhaler with extrafine formoterol; the co-primary end-points are exacerbation rates over 48 weeks and improvement in forced expiratory volume in 1 s over 12 weeks. ⋯ FORWARD is therefore expected to provide information on the ability of EXACT to detect and measure exacerbations in a large clinical trial setting. The study design of FORWARD is described in this article.
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Randomized Controlled Trial
Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study.
The efficacy and safety of two doses of aclidinium bromide were evaluated in patients with moderate to severe chronic obstructive pulmonary disease (COPD). In this 24-week, double-blind trial, patients were randomised to twice-daily aclidinium (200 μg or 400 μg) or placebo. The primary efficacy end-point was change in trough forced expiratory volume in 1 s (FEV(1)) at week 24. ⋯ Aclidinium 200 μg and 400 μg produced significant improvements over placebo in baseline-adjusted mean SGRQ total score (-3.8 and -4.6 units; p<0.001 and p<0.0001) and TDI focal score (0.6 and 1.0 units; p<0.05 and p<0.001) at week 24. With both aclidinium doses, the incidence of anticholinergic adverse events was low, and similar to placebo. Twice-daily aclidinium significantly improved bronchodilation, health status and dyspnoea, and was well tolerated in patients with COPD.
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Randomized Controlled Trial
24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids.
Current guidelines recommend adding a long-acting inhaled β(2)-agonist (LABA) to inhaled corticosteroids (ICS) in patients with uncontrolled asthma. This study evaluated the novel, once-daily LABA vilanterol trifenatate (VI) in asthma patients who remained symptomatic despite existing ICS therapy. The study involved a randomised, double-blind, placebo-controlled trial of VI (3, 6.25, 12.5, 25 and 50 μg), administered once daily in the evening by dry powder inhaler for 28 days, in asthma patients aged ≥ 12 yrs symptomatic on current ICS therapy. ⋯ All doses of VI were well tolerated with low incidences of recognised LABA-related adverse events (tremor 0-2%; palpitations 0-2%; glucose effects 0-1%; potassium effects 0-<1%). Once-daily VI 12.5-50 μg resulted in prolonged bronchodilation of at least 24 h with good tolerability in asthma patients receiving ICS. Based on the overall efficacy and adverse event profile from this study, the optimum dose of VI appears to be 25 μg.
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Randomized Controlled Trial Multicenter Study Comparative Study
Moxifloxacin versus amoxicillin/clavulanic acid in outpatient acute exacerbations of COPD: MAESTRAL results.
Bacterial infections causing acute exacerbations of chronic obstructive pulmonary disease (AECOPD) frequently require antibacterial treatment. More evidence is needed to guide antibiotic choice. The Moxifloxacin in Acute Exacerbations of Chronic Bronchitis TriaL (MAESTRAL) was a multiregional, randomised, double-blind non-inferiority outpatient study. ⋯ Patients treated with oral corticosteroids had more severe disease and higher failure rates. The MAESTRAL study showed that moxifloxacin was as effective as amoxicillin/clavulanic acid in the treatment of outpatients with AECOPD. Both therapies were well tolerated.
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Randomized Controlled Trial
Physiological effects of roflumilast at rest and during exercise in COPD.
The purpose of this study was to investigate the effects of 500 μg roflumilast, taken once daily for 12 weeks, on airway physiology during rest and exercise in patients with moderate-to-severe chronic obstructive pulmonary disease. This randomised, double-blind, placebo-controlled, parallel-group study was conducted in 250 patients with a post-bronchodilator forced expiratory volume in 1 s (FEV(1)) of 30-80% predicted and a functional residual capacity of ≥ 120% pred. Pre- and post-bronchodilator spirometry and body plethysmography, and pre-bronchodilator constant work rate cycle exercise at 75% of peak work rate were evaluated. ⋯ At a standardised exercise time after roflumilast, compared with placebo, IC increased by 0.12 L (p = 0.008) and S(p,O(2)) increased by 0.7% (p = 0.020); peak ventilation increased by 1.9 L · min(-1) (p = 0.014). Roflumilast treatment was associated with progressive improvement of airway function but not lung hyperinflation. Newly described non-bronchodilator effects of roflumilast included small but consistent improvements in air trapping and S(p,O(2)) during exercise.