QVA149 lung function study
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, two-period crossover study to assess the effect of inhaled QVA149 on global and regional lung function and gas exchange in patients with moderate to severe COPD
IRAS ID
173712
Contact name
Dave Singh
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-004461-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
RESP5263, NIHR CRN reference
Duration of Study in the UK
0 years, 10 months, 15 days
Research summary
This study is in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD), a disease of progressive airflow obstruction affecting approximately 20% of chronic smokers. It is a major cause of poor health and death worldwide, contributing significantly to healthcare costs.\n\nCurrent treatment guidelines for moderate-severe COPD patients recommend the use of bronchodilators. Different types of bronchodilators are available as short-acting B2 adrenergic agonists (SABA), short-acting muscarinic antagonists (SAMA), long-acting B2 adrenergic agonists (LABA) and long-acting muscarinic antagonists (LAMA). The treatment assessed in this study is a fixed dose combination of QVA149, a LABA+LAMA combination. QVA149 is approved by the European Medicines Agency (EMA) for the treatment of COPD.\n\nThis study is double-blind which means that participants and the doctors/nurses treating them will not know which treatment they have been randomly assigned (QVA149 or a placebo). \n\nThis is a two-period cross-over study which means that patients assigned to receive QVA149 will do so for 8-10 days. They will then have a “wash-out” period where they receive no study medication, then will receive placebo for 8-10 days. Similarly, patients assigned to receive placebo will do so for 8-10 days, have a “wash-out” period, then will receive QVA149 for 8-10 days.\n\nThe study will investigate how QVA149 works to distribute air in the lungs of COPD patients. This will be assessed by magnetic resonance imaging (MRI). Current tests of lung ventilation are not very accurate and give variable results.\n\nPatients will also receive a SABA inhaler as rescue medication during the study (salbutamol/albuterol). If patients were taking inhaled corticosteroids (ICS) for their disease before the study they will remain on ICS during the study.\n\nPatients will be on study for approximately 8 weeks and the aim is to recruit 34 patients in 3 UK sites.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0218
Date of REC Opinion
25 Apr 2016
REC opinion
Further Information Favourable Opinion