Phase IIIB/IV study of NVA237 in patients with moderate to severe COPD
Research type
Research Study
Full title
A randomized, double-blind, parallel group, 26-week study evaluating the efficacy, safety and tolerability of NVA237 given once or twice daily, in patients with moderate and severe chronic obstructive pulmonary disease
IRAS ID
187326
Contact name
Mark Elliott
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2014-004818-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 8 days
Research summary
Chronic obstructive pulmonary disease (COPD) is a slow, progressive airflow limitation that cannot be fully reversed. COPD is a mixture of a number of conditions including emphysema and chronic bronchitis. It is a major cause of poor health and death worldwide. Current treatment guidelines for COPD recommend the use of bronchodilators for all severities.
NVA237 (Glycopyrronium bromide) works by relaxing the airways in the lungs over about 24 hours, to make breathing easier. It is approved only at a dose of 44 μg once a day as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. The Sponsor of this study ( Novartis) were requested by the EMA to conduct a post-authorization efficacy study (PAES) to compare the efficacy, safety and tolerability of glycopyrronium given at a dose of 44 μg once a day and 22 μg twice a day (not approved) in patients with stable COPD and moderate to severe airflow obstruction.
Study CNVA237A2320 fulfills this request. Participants will be randomly assigned to the 22 μg twice a day or 44 μg once a day doses.
The study has a screening period of up to 7 days, a 14 day run-in period and a 26 week treatment period. Participants will need to attend clinic for a total of 6 times over a period of 6 months and have 1 telephone visit. 3 of the visits will take approximately 1 to 2 hours and the other 3 would last approximately 24 hours each.
Procedures include: physical examinations, vital signs, electrocardiograms, urine and blood samples for laboratory tests, lung function tests (spirometry), dyspnea (shortness of breath) evaluation, and Quality of Life and respiratory questionnaires.
Approximately 752 participants will take part in the study, and approximately 30 are expected from the UK.REC name
North East - York Research Ethics Committee
REC reference
15/NE/0298
Date of REC Opinion
15 Oct 2015
REC opinion
Further Information Favourable Opinion