scholarly journals A Randomized Controlled Trial to Assess the Efficacy of Tiotropium in Canadian Patients with Chronic Obstructive Pulmonary Disease

2007 ◽  
Vol 14 (8) ◽  
pp. 465-472 ◽  
Author(s):  
Charles KN Chan ◽  
François Maltais ◽  
Chris Sigouin ◽  
Jennifer M Haddon ◽  
Gordon T Ford ◽  
...  

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) who smoke have a greater annual rate of decline in forced expiratory volume in 1 s (FEV1) than those patients who have stopped smoking.OBJECTIVES: To assess the effect of tiotropium on pre-dose (trough) FEV1in patients with COPD followed in Canada.METHODS: A total of 913 patients were randomly assigned to receive either tiotropium 18 μg once daily (n=608) or placebo (usual care minus inhaled anticholinergics) (n=305) for 48 weeks in the present randomized, double-blind, parallel-group study. The effect of tiotropium on measurements of lung function (FEV1, FEV6and forced vital capacity), symptoms, health-related quality of life (St George’s Respiratory Questionnaire) and exacerbations were examined.RESULTS: Tiotropium improved trough FEV1in both current and ex-smokers compared with placebo. Baseline FEV1in smokers and ex-smokers was 1.03 L and 0.93 L, respectively (P<0.001). At week 48, the mean difference between the tiotropium and placebo groups was 0.14±0.04 L (P<0.001) in the smoker group and 0.08±0.02 L (P<0.0001) in the ex-smoker group. Tiotropium also significantly improved trough forced vital capacity and FEV6compared with placebo throughout the treatment period (P<0.05, for all). Furthermore, tiotropium significantly improved the St George’s Respiratory Questionnaire total score compared with placebo at week 48 (40.9 versus 43.7 units, P<0.005).CONCLUSIONS: Compared with the placebo group, tiotropium provides sustained improvements in lung function in patients with COPD, with improvements for smokers and ex-smokers.

2016 ◽  
Vol 24 (2) ◽  
pp. 216-224 ◽  
Author(s):  
Eva Broendum ◽  
Charlotte Suppli Ulrik ◽  
Thorbjorn Gregersen ◽  
Ejvind Frausing Hansen ◽  
Allan Green ◽  
...  

The aim of this analysis is to investigate reasons why patients with chronic obstructive pulmonary disease decline to participate in a controlled trial of telemedicine. Patients with previous chronic obstructive pulmonary disease exacerbations were invited to participate in a 6-month randomized telemedicine trial. For eligible patients, reasons for refusal were registered. Of 560 eligible patients, 279 (50%) declined to participate in the trial, 257 (92%) reported a reason: 53 (20.6%) technical concerns, 164 (63.8%) personal reasons, 17 (6.6%) preferred outpatient clinic visits, and 23 (8.9%) did not want to participate in clinical research. Compared to consenting patients, subjects declining participation were significantly older, more often female, had higher lung function (%predicted), lower body mass index, higher admission-rate for chronic obstructive pulmonary disease in the previous year, and were more often diagnosed with osteoporosis. Many eligible patients decline participating in a controlled tele-healthcare trial and, furthermore, a tailored approach for recruiting females and elderly patients appears appropriate.


2018 ◽  
Vol 10 (12) ◽  
pp. 6547-6556
Author(s):  
Chunlan Chen ◽  
Ying He ◽  
Qiulin Chen ◽  
Dongying Zhang ◽  
Yuandi Wang ◽  
...  

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e053446
Author(s):  
Allison Martin ◽  
Robert J Hancox ◽  
Catherina L Chang ◽  
Richard Beasley ◽  
Jeremy Wrobel ◽  
...  

IntroductionHeart disease in chronic obstructive pulmonary disease (COPD) is a common but neglected comorbidity. Patients with COPD are frequently excluded from clinical trials of treatments aimed at reducing cardiac morbidity and mortality, which has led to undertreatment of cardiovascular disease in patients with COPD. A particular concern in COPD is the underuse of beta (β)-blockers. There is observational evidence that cardioselective β-blockers are safe and may even reduce mortality risk in COPD, although some evidence is conflicting. There is an urgent need to answer the research question: Are cardioselective β-blockers safe and of benefit in people with moderately severe COPD? The proposed study will investigate whether cardioselective β-blocker treatment in patients with COPD reduces mortality and cardiac and respiratory morbidity.Methods and analysesThis is a double-blind, randomised controlled trial to be conducted in approximately 26 sites in Australia, New Zealand, India, Sri Lanka and other countries as required. Participants with COPD will be randomised to either bisoprolol once daily (range 1.25–5 mg, dependent on tolerated dose) or matched placebo, in addition to receiving usual care for their COPD over the study duration of 24 months.The study will enrol 1164 participants with moderate to severe COPD, aged 40–85 years. Participants will be symptomatic from their COPD and have a postbronchodilator forced expiratory volume in 1 s (FEV1) ≥30% and ≤70% predicted and a history of at least one exacerbation requiring systemic corticosteroids, antibiotics or both in the prior 24 months.Ethics and disseminationThe study protocol has been approved by the Sydney Local Health District Human Research Ethics Committee at The Concord Repatriation General Hospital.Trial registration numbersNCT03917914; CTRI/2020/08/027322.


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