CQVM149B2209 - compare morning vs evening doses of QVM149 o.d.
Research type
Research Study
Full title
A randomized, double-blind, repeat dose cross-over study to assess the bronchodilator effects of once daily QVM149 following morning or evening dosing for 14 days compared to placebo in patients with asthma.
IRAS ID
233098
Contact name
Dave Singh
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2017-000644-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 11 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 the time of dosing (morning or evening) has any influence on the bronchodilator effect (ability to widen the airway in the lungs) using once daily orally inhaled QVM149 compared to placebo.Eligible participants will receive a fixed dose of QVM149 and matching placebo in the morning and evening.
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, a run-in period of 2 weeks, followed by 3 treatment periods of 14 days - separated by 2 washout periods (14-21 days) and an end of study visit.
Approximately 10-15 participants are anticipated to be enrolled from the UK.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0487
Date of REC Opinion
3 Oct 2017
REC opinion
Further Information Favourable Opinion