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

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ClinicalTrials.gov Identifier: NCT02449018
Recruitment Status : Completed
First Posted : May 20, 2015
Results First Posted : April 2, 2018
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 30, 2015
First Posted Date  ICMJE May 20, 2015
Results First Submitted Date  ICMJE January 18, 2018
Results First Posted Date  ICMJE April 2, 2018
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE April 30, 2015
Actual Primary Completion Date December 27, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
Change From Baseline in Lung Clearance Index (LCI) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2015)
Change from Baseline in Lung Clearance Index (LCI) [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
  • Change From Baseline in FEV1 Pre-bronchodilator [ Time Frame: 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.
  • Change From Baseline in FEV1 Post-bronchodilator [ Time Frame: 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 FVC Pre Bronchodilator [ Time Frame: 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 [ Time Frame: 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
  • Change From Baseline in TLC [ Time Frame: 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.
  • Change From Baseline in RV [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 29 ]
    Diffusing capacity of the lung for carbon monoxide (DLCO) is the extent to which oxygen passes from the lung to the blood.
  • Plasma Concentration of QBW251 by TMax (0-8hours) [ Time Frame: Day 1, Day 28 ]
    Tmax is the time to reach the maximum concentration after drug administration.
  • Plasma Concentration of QBW251 by CMax (0-8hours) [ Time Frame: Day 1, Day 28 ]
    Cmax is the observed maximum plasma concentration following drug administration.
  • Plasma Concentration of QBW251 by AUClast (0-8hours) [ Time Frame: 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.
  • Plasma Concentration of QBW251 by AUC0-12h [ Time Frame: Day 1, Day 28 ]
    AUC 0-12h is the area under the plasma concentration-time curve from time zero to 12 hours.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2015)
  • Change From Baseline in FEV1 [ Time Frame: Day 29 ]
    Change From Baseline to Day 29 in FEV1 will be measured by spirometry. 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.
  • Number of participants with adverse events receiving QBW251 [ Time Frame: Day 1 to Day 56 ]
    Safety and tolerability will be measured by number and percentage of participants with adverse events.
  • Pharmacokinetics: Plasma concentration of QBW251 by CMax [ Time Frame: Day 1, Day 28 ]
    Cmax is the observed maximum plasma concentration following drug administration.
  • Change From Baseline in FVC [ Time Frame: Day 29 ]
    Change From Baseline to Day 29 in FVC will be measured by spirometry. 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.
  • Change From Baseline in TLC [ Time Frame: 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.
  • Change From Baseline in RV [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 29 ]
    Diffusing capacity of the lung for carbon monoxide (DLCO) is the extent to which oxygen passes from the lung to the blood.
  • Pharmacokinetics: Plasma concentration of QBW251 by TMax [ Time Frame: Day 1, Day 28 ]
    Tmax is the time to reach the maximum concentration after drug administration.
  • Pharmacokinetics: Plasma concentration of QBW251 by AUClast [ Time Frame: 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.
  • Pharmacokinetics: Plasma concentration of QBW251 by AUC0-12h [ Time Frame: Day 1, Day 28 ]
    AUC 0-12h is the area under the plasma concentration-time curve from time zero to 12 hours.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251
Official Title  ICMJE A Randomized, Double Blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Multiple Doses of QBW251 in Patients With COPD
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease, COPD
Intervention  ICMJE
  • Drug: QBW251
    QBW251 capsule(s) taken orally twice per day
  • Drug: Placebo
    Matching placebo capsule(s) taken orally twice per day
Study Arms  ICMJE
  • Experimental: QBW251
    QBW251 will be provided to participants during 70 days
    Intervention: Drug: QBW251
  • Placebo Comparator: Placebo
    Placebo will be provided to participants during 70 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2017)
92
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2015)
90
Actual Study Completion Date  ICMJE January 23, 2017
Actual Primary Completion Date December 27, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02449018
Other Study ID Numbers  ICMJE CQBW251X2201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP