CQVM149B2208 - compare 2 doses of QVM149 vs sal/flu on bronchodilation
Research type
Research Study
Full title
A randomized, double-blind, double-dummy, active-controlled, 3-period complete cross-over study to assess the bronchodilator effect and safety of two doses of QVM149 compared to a fixed dose combination of salmeterol/fluticasone in patients with asthma.
IRAS ID
216658
Contact name
Dave Singh
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2016-005164-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 15 days
Research summary
This study is in patients with asthma which is a disease of airway hyper-responsiveness and associated variable airflow obstruction. An estimated 300 million people are affected worldwide. It is a major cause of poor health and death worldwide and contributes significantly to healthcare costs.
Recently a long-acting muscarinic antagonist (LAMA) called tiotropium has been approved in the EU as an add on treatment in adults who are currently treated with an inhaled corticosteroids (ICS) and long-acting beta2 agonists (LABA) and have had one or more severe asthma exacerbations in the last year. The global asthma guidelines (GINA) have been updated to incorporate this add on therapy.
The treatment under assessment in this study is a drug called QVM149 which is taken using an inhaler device. QVM149 is a combination of a LABA, LAMA and ICS and these medicines work by opening up the airways and reducing inflammation in them also. Each active component of QVM149 is available on prescription for the treatment of chronic obstructive pulmonary disease (COPD) but not yet approved for the treatment of asthma.
This study is looking to see if 2 different doses of QVM149 have more beneficial effects in patients with asthma compared to a combination drug called salmeterol/fluticasone (LABA/ICS) which is currently used in the treatment for asthma.
Eligible participants will receive the following treatments in any order:
QVM149 mid-dose
QVM149 higher dose
salmeterol/fluticasone fixed dose
All participants will receive a short acting beta agonist (SABA) rescue medication in case of worsening asthma symptoms.
The study will consist of a screening period of up to 2 weeks, 3 treatment periods of 21 days and a study completion visit.
The aim is to include 114 participants from countries in Europe and Asia, of which 15 will be from 1 UK centre.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0486
Date of REC Opinion
9 Oct 2017
REC opinion
Further Information Favourable Opinion