QBW251B2201 24 Weeks QBW251 in COPD patients on triple inhaled therapy
Research type
Research Study
Full title
A 24-week multi-center, double-blind, placebo controlled dose range finding study to investigate the efficacy and safety of oral QBW251 in COPD patients on triple inhaled therapy (LABA/LAMA/ICS)
IRAS ID
275189
Contact name
Jadwiga Wedzicha
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-003197-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 28 days
Research summary
Research Summary
Chronic obstructive pulmonary disease (COPD) is characterised by persistent respiratory symptoms and airflow limitation that is due to airway abnormalities usually caused by significant exposure to noxious gases, in particular cigarette smoke. COPD is a critically important disease, with a prevalence of 10% - 15% in Europe, approximately 10% in South East Asia and approximately 15% in the Americas. COPD is the third leading cause of death worldwide. COPD is associated with episodic periods of symptom deterioration termed exacerbations. Exacerbations are amongst the most common causes of medical admission to hospital and responsible for much of the morbidity and mortality associated with this highly prevalent condition. COPD is also associated with significant healthcare expenditures.
Chronic bronchitis, due to mucous hypersecretion and mucociliary dysfunction, is a key phenotype amongst COPD patients. Bronchitic patients have higher exacerbation frequency and more likely to be hospitalised. Effective treatment options are extremely limited in this group and almost 70% of patients remain significantly limited by breathlessness and 40% experience ≥ 2 moderate or ≥ 1 severe exacerbation per year, therefore additional novel therapies are urgently needed.
Research indicates that cigarette smoking induces an acquired state of cystic fibrosis transmembrane conductance regulator (CFTR) dysfunction in the respiratory tract, and may contribute to COPD. Modulation of CFTR function should improve airway hydration, decreasing mucus viscosity and enhancing mucociliary clearance. CFTR potentiators increase the activity of the CFTR channel present in the cell membrane of the lungs epithelium. QBW251 is a novel potentiator of the CFTR channel that, in a previous study, demonstrated improvement in lung function and sweat chloride over placebo, in addition to reducing systemic inflammation.
Therefore, QBW251 will be a first-in-class oral CFTR potentiator, with the capacity to reduce COPD exacerbations and improve symptoms, quality of life and lung function when added to inhaled therapies.Summary of Results
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REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1867
Date of REC Opinion
23 Mar 2020
REC opinion
Further Information Favourable Opinion