Assessing the benefits of aclidinium bromide in COPD patients
Research type
Research Study
Full title
A randomised, double blind, placebo controlled, parallel study to assess the benefits of aclidinium bromide in the relief of COPD symptoms including cough when administered to patients with COPD
IRAS ID
164497
Contact name
Elizabeth Bushe
Contact email
Sponsor organisation
AstraZeneca AB; Karlebyhus, Astraallén, Södertälje SE-151 85
Eudract number
2014-004715-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
years, 10 months, 15 days
Research summary
Chronic obstructive pulmonary disease (COPD), also called chronic obstructive airways disease (COAD) is the general term for a combination of chronic bronchitis and emphysema. COPD is a common preventable and treatable disease that persistently narrows the airways, causing increasing breathing difficulties combined with increased cough and mucus. The disease affects 25% of all adults older than 40 years and is the fourth leading cause of death in the world, it is thought by 2020 COPD will be the third leading cause of death in the world.
The characteristic symptoms of COPD are chronic and progressive dyspnea (shortness of breath), chronic cough, and increased sputum production that can be variable from day-to-day. These symptoms reflect the daily burden encountered by patients with COPD and have a real impact on their health-related quality of life. Clinical studies have shown that cough is often the first COPD symptom to develop resulting in a lower health-related quality of life. Cough is an important symptom in the diagnosis of COPD and it has been suggested that its assessment and treatment should have a more prominent place in COPD clinical management.
The study will assess the effect of a marketed drug, aclidinium bromide, 400 µg administered twice a day by inhalation compared to placebo (a dummy drug) on COPD symptoms in a symptomatic patients population aged 40 years and older, with moderate COPD and chronic bronchitis. The study aims to assess the effects of the study drug on COPD symptoms by using specific and validated tools, e.g. Respiratory Symptoms Questionnaires. Some patients participating in the study will also take part in a smaller sub study, looking at cough in detail over several 24 hour periods. The study will be conducted in Europe and will last 11-12 weeks.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0051
Date of REC Opinion
9 Mar 2015
REC opinion
Further Information Favourable Opinion