Overview
A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251
Status:
Completed
Completed
Trial end date:
2017-01-23
2017-01-23
Target enrollment:
0
0
Participant gender:
All
All
Summary
To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo administered orally, on airway function, lung volume, and quality of life in patients with chronic obstructive pulmonary disease (COPD)Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novartis Pharmaceuticals
Criteria
Inclusion Criteria: Must have a diagnosis of GOLD II-III chronic obstructive pulmonarydisease (COPD); Must have clinical diagnosis of chronic bronchitis; Must be either a
current smoker (smoked ≤ 1 pack per day on average for the last 3 months with at least a 10
pack year smoking history) OR an ex-smoker with at least a 10 pack year smoking history;
Exclusion Criteria: Must not be receiving chronic, daily, systemic steroids; Must not have
severe emphysema (determined by HRCT); Must not have had a COPD exacerbation or respiratory
tract infection requiring antibiotics or oral steroids or hospitalization within 6 weeks of
screening; Must not be pregnant or nursing or a woman of child bearing potential; Other
protocol-defined inclusion/exclusion criteria may apply