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

Chronic Obstructive Pulmonary Disease, COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449018
• Other study ID #: CQBW251X2201
• Status: Completed
• Phase: Phase 2
• Start date: April 30, 2015
• Est. completion date: January 23, 2017

Study information

• Verified date: April 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 23, 2017
• Est. primary completion date: December 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease, COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• QBW251
QBW251 capsule(s) taken orally twice per day
• Placebo
Matching placebo capsule(s) taken orally twice per day

Locations

Country	Name	City	State
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Sobotka
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Clearwater	Florida
United States	Novartis Investigative Site	Fullerton	California
United States	Novartis Investigative Site	Huntersville	North Carolina
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Normal	Illinois
United States	Novartis Investigative Site	Port Orange	Florida
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Shelby	North Carolina
United States	Novartis Investigative Site	Simpsonville	South Carolina
United States	Novartis Investigative Site	Spartanburg	South Carolina
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Union	South Carolina
United States	Novartis Investigative Site	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Lung Clearance Index (LCI)	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.	Baseline and Day 29
Secondary	Change From Baseline in FEV1 Pre-bronchodilator	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.	Day 29
Secondary	Change From Baseline in FEV1 Post-bronchodilator	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.	Day 29
Secondary	Change From Baseline in FVC Pre Bronchodilator	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	Day 29
Secondary	Change From Baseline in FVC Post- Bronchodilator	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	Day 29
Secondary	Change From Baseline in TLC	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.	Day 29
Secondary	Change From Baseline in RV	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.	Day 29
Secondary	Change From Baseline in FRC	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.	Day 29
Secondary	Change From Baseline in DLCO	Diffusing capacity of the lung for carbon monoxide (DLCO) is the extent to which oxygen passes from the lung to the blood.	Day 29
Secondary	Plasma Concentration of QBW251 by TMax (0-8hours)	Tmax is the time to reach the maximum concentration after drug administration.	Day 1, Day 28
Secondary	Plasma Concentration of QBW251 by CMax (0-8hours)	Cmax is the observed maximum plasma concentration following drug administration.	Day 1, Day 28
Secondary	Plasma Concentration of QBW251 by AUClast (0-8hours)	AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.	Day 1, Day 28
Secondary	Plasma Concentration of QBW251 by AUC0-12h	AUC 0-12h is the area under the plasma concentration-time curve from time zero to 12 hours.	Day 1, Day 28

External Links

•   A Plain Language Trial Summary is available on novartisclinicatrials.com