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OpenTrials
Completed

NCT Number: NCT02449018

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

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)

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Key information

Conditions

Chronic Obstructive Pulmonary Disease, COPD Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Disease Disease Attributes Infections Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Lodz, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QBW251

Drug

QBW251 capsule(s) taken orally twice per day

Placebo

Drug

Matching placebo capsule(s) taken orally twice per day

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Plasma Concentration of QBW251 by CMax (0-8hours)

    Time frame: Day 1, Day 28

    Cmax is the observed maximum plasma concentration following drug administration.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 20, 2015
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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