Pulmonary pharmacology & therapeutics
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Pulm Pharmacol Ther · Dec 2012
Randomized Controlled Trial Multicenter Study28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial.
Umeclidinium (UMEC; GSK573719) is a new long-acting muscarinic antagonist (LAMA) currently in development in combination with vilanterol (VI), an inhaled, long-acting beta₂ agonist for the treatment of chronic obstructive pulmonary disease (COPD). The primary aim of this study was to evaluate the safety and tolerability of repeat dosing of UMEC and VI in combination once daily for 28 days in patients with COPD. ⋯ Once-daily dosing with UMEC in combination with VI in patients with moderate-to-very-severe COPD was well tolerated over 28 days.
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Pulm Pharmacol Ther · Jun 2012
Randomized Controlled Trial Multicenter Study Comparative StudyA randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients.
This Phase IIb, double-blind, double-dummy, placebo- and active-comparator-controlled crossover study (ClinicalTrials.gov identifier: NCT01120093) assessed efficacy and safety of three doses of aclidinium bromide in patients with moderate to severe chronic obstructive pulmonary disease. Patients were randomised to one of five treatment sequences each consisting of twice-daily (BID) aclidinium 100 μg, 200 μg, 400 μg (via Genuair®*), formoterol 12 μg (via Aerolizer®) and matched placebo for 7 days, with a 5- to 9-day washout period. Primary endpoint was mean change from baseline in forced expiratory volume in 1 s (FEV1) normalised area under the curve (AUC)0-12 on Day 7. ⋯ The safety profile of aclidinium was comparable to placebo. These results demonstrated that twice-daily aclidinium produced dose-dependent clinically meaningful improvements in FEV1 compared with placebo. This study also confirmed the use of an aclidinium BID dosing regimen and established aclidinium 200 μg and 400 μg as suitable doses for further investigation in Phase III trials.
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Pulm Pharmacol Ther · Dec 2011
Randomized Controlled TrialThe efficacy of nebulized salbutamol, hypertonic saline and salbutamol/hypertonic saline combination in moderate bronchiolitis.
The mainstay of treatment in bronchiolitis includes oxygenation, aspiration of secretions from the respiratory tract and maintenance of hydration. The first choice medical agent in clinical practice is nebulized bronchodilators, although their place in treatment is controversial. ⋯ The CBSSs of all the infants improved after three doses of nebulized therapy regardless of the treatment regimens. The combination of salbutamol with hypertonic saline did not lead to an additive effect in the improvement of CBSSs compared to the standard salbutamol + NS combination. Atopic children benefited from salbutamol/NS combination whereas non-atopic children improved with HS and NS nebulizations based on improvement percentages of CBSS.
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Pulm Pharmacol Ther · Oct 2011
Randomized Controlled Trial Multicenter StudySafety and tolerability of an oral MMP-9 and -12 inhibitor, AZD1236, in patients with moderate-to-severe COPD: a randomised controlled 6-week trial.
Matrix metalloproteinases (MMPs) have been implicated in the pathogenesis of chronic obstructive pulmonary disease (COPD). This phase IIa study investigated the safety and tolerability of oral AZD1236, an MMP-9 and MMP-12 inhibitor, in patients with COPD. Efficacy analyses were included on an exploratory basis. ⋯ For most of these COPD patients, with the particular exception of one who experienced a serious AE, AZD1236 at 75 mg twice daily was generally well tolerated and had an acceptable safety profile. Therapeutic efficacy could not be demonstrated, possibly due to the stable disease and background medications of the patients enrolled in this small, short-term study.
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Pulm Pharmacol Ther · Jun 2010
Randomized Controlled Trial Multicenter StudyLong-term azithromycin use in patients with chronic obstructive pulmonary disease and tracheostomy.
Patients with Chronic Obstructive Pulmonary Disease (COPD) and tracheostomy are at high risk for exacerbations and hospitalizations. Macrolide treatment has shown to reduce exacerbations in moderate-to-severe COPD. To evaluate the safety and the efficacy of long-term azithromycin use in outpatients with severe COPD and tracheostomy. ⋯ Azithromycin significantly improved the quality of life in comparison to SC. No serious adverse events in the AZI group were reported. Long-term azithromycin treatment seems to be safe and effective in severe COPD outpatients with tracheostomy in reducing exacerbations, hospitalizations, as well as in improving quality of life.