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Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03215758
Recruitment Status : Completed
First Posted : July 12, 2017
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE July 11, 2017
First Posted Date  ICMJE July 12, 2017
Last Update Posted Date October 21, 2019
Actual Study Start Date  ICMJE November 1, 2017
Actual Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2017)
Pre-dose Forced Expiratory Volume in 1 second (FEV1) (L) [ Time Frame: Week 12 ]
Change from baseline in pre- dose FEV1 [in liters].
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03215758 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2017)
  • Daytime asthma symptom score [ Time Frame: 12 weeks ]
    Change from baseline in daytime asthma symptom score.
  • Short-acting beta agonist (SABA) taken per day [ Time Frame: 12 weeks ]
    Change from baseline in number of puffs of SABA taken per day.
  • Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) score [ Time Frame: Week 12 ]
    Change from baseline in Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) score.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Official Title  ICMJE A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Brief Summary A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: QAW039
    QAW039 once daily
  • Drug: Placebo
    Placebo once daily
Study Arms  ICMJE
  • Active Comparator: QAW039
    QAW039 once daily
    Intervention: Drug: QAW039
  • Placebo Comparator: Placebo
    Placebo once daily
    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: July 26, 2019)
675
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2017)
650
Actual Study Completion Date  ICMJE July 30, 2019
Actual Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
  • Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
  • FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18 years.
  • Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days of the placebo run- in period.
  • Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.
  • Demonstrated reversible airway obstruction.
  • Asthma control questionnaire (ACQ) score ≥ 1.5.

Exclusion Criteria:

  • Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
  • A resting QTcF (Fridericia) ≥450 msec (male) or

    ≥460 msec (female).

  • Pregnant or nursing (lactating) women.
  • Serious co-morbidities.
  • Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, 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 Argentina,   Germany,   Hungary,   Mexico,   Philippines,   Saudi Arabia,   Slovakia,   South Africa,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03215758
Other Study ID Numbers  ICMJE CQAW039A2316
2017-001273-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 Not Provided
PRS Account Novartis
Verification Date October 2019

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