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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02449018
First received: March 30, 2015
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
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)

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease, COPD Drug: QBW251 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 90
Study Start Date: April 2015
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QBW251
QBW251 will be provided to participants during 70 days
Drug: QBW251
QBW251 capsule(s) taken orally twice per day
Placebo Comparator: Placebo
Placebo will be provided to participants during 70 days
Drug: Placebo
Matching placebo capsule(s) taken orally twice per day

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02449018

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

Locations
United States, Alabama
Novartis Investigative Site Recruiting
Birmingham, Alabama, United States, 35294
United States, California
Novartis Investigative Site Recruiting
Fullerton, California, United States, 92835
United States, Connecticut
Novartis Investigative Site Recruiting
Waterbury, Connecticut, United States, 06708
United States, Florida
Novartis Investigative Site Recruiting
Clearwater, Florida, United States, 33765
Novartis Investigative Site Recruiting
Port Orange, Florida, United States, 32127
Novartis Investigative Site Recruiting
Tampa, Florida, United States, 33603
United States, Illinois
Novartis Investigative Site Recruiting
Normal, Illinois, United States, 61761
United States, Missouri
Novartis Investigative Site Completed
St. Louis, Missouri, United States, 63141
United States, North Carolina
Novartis Investigative Site Recruiting
Shelby, North Carolina, United States, 28152
United States, Oregon
Novartis Investigative Site Recruiting
Medford, Oregon, United States, 97504-8741
United States, South Carolina
Novartis Investigative Site Recruiting
Simpsonville, South Carolina, United States, 29681
Novartis Investigative Site Recruiting
Spartanburg, South Carolina, United States, 29303
Novartis Investigative Site Recruiting
Union, South Carolina, United States, 29379
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02449018     History of Changes
Other Study ID Numbers: CQBW251X2201
Study First Received: March 30, 2015
Last Updated: September 20, 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
COPD,
chronic bronchitis,
inflammation,
airway,
LCI,
pulmonary function test,
lung function,
controlled clinical trial,
randomized,
airflow,
smoker

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2017