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

Phase 2

Completed

Conditions: Chronic Obstructive Pulmonary Disease, COPD

Interventions: Drug: QBW251
Drug: Placebo

Registration Number: NCT02449018

Lead Sponsor: Novartis Pharmaceuticals

Brief 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)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 92

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QBW251	QBW251	QBW251 will be provided to participants during 70 days
Placebo	Placebo	Placebo will be provided to participants during 70 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Lung Clearance Index (LCI)	Baseline and Day 29	Change from baseline to Day 29 in LCI as measured by multiple breath nitrogen washout (MBNW) technique. MBNW is the time taken to wash out nitrogen while breathing 100% oxygen.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in FEV1 Post-bronchodilator	Day 29	Change From Baseline to Day 29 in FEV1 will be measured by spirometer after bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
Change From Baseline in TLC	Day 29	Change From Baseline to Day 29 in TLC will be measured by spirometry. Total lung capacity (TLC) is the volume in the lungs at maximal inflation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
Plasma Concentration of QBW251 by CMax (0-8hours)	Day 1, Day 28	Cmax is the observed maximum plasma concentration following drug administration.
Plasma Concentration of QBW251 by AUC0-12h	Day 1, Day 28	AUC 0-12h is the area under the plasma concentration-time curve from time zero to 12 hours.
Change From Baseline in FEV1 Pre-bronchodilator	Day 29	Change From Baseline to Day 29 in FEV1 will be measured by spirometer before bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
Plasma Concentration of QBW251 by TMax (0-8hours)	Day 1, Day 28	Tmax is the time to reach the maximum concentration after drug administration.
Change From Baseline in RV	Day 29	Change From Baseline to Day 29 in RV will be measured by spirometry. Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
Change From Baseline in FRC	Day 29	Change From Baseline to Day 29 in FRC will be measured by spirometry. Functional residual capacity (FRC) is the volume in the lungs at the end-expiratory position. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
Change From Baseline in DLCO	Day 29	Diffusing capacity of the lung for carbon monoxide (DLCO) is the extent to which oxygen passes from the lung to the blood.
Change From Baseline in FVC Pre Bronchodilator	Day 29	Change From Baseline to Day 29 in FVC will be measured by spirometer before bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator
Change From Baseline in FVC Post- Bronchodilator	Day 29	Change From Baseline to Day 29 in FVC will be measured by spirometer after bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator
Plasma Concentration of QBW251 by AUClast (0-8hours)	Day 1, Day 28	AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.