A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251

Status:	Completed
Conditions:	Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - 75
Updated:	5/4/2018
Start Date:	April 30, 2015
End Date:	January 23, 2017

A Randomized, Double Blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Multiple Doses of QBW251 in Patients With COPD

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)

Inclusion Criteria: Must have a diagnosis of GOLD II-III chronic obstructive pulmonary
disease (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

We found this trial at

sites

Novartis Investigational Site

Tampa, Florida 33613

from

Tampa, FL