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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
QAW039
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring QAW039, uncontrolled asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

QAW039

Placebo

Arm Description

QAW039 once daily

Placebo once daily

Outcomes

Primary Outcome Measures

Change From Baseline in Pre-dose FEV1
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.

Secondary Outcome Measures

Change From Baseline in Daytime Asthma Symptom Score
Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score is calculated for the responses to 4 questions.
Change From Baseline in Number of Puffs of SABA Taken Per Day
Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily - at the same time each morning and each evening, approximately 12 hours apart.
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score
AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.

Full Information

First Posted
July 11, 2017
Last Updated
October 6, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03226392
Brief Title
Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
July 5, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
QAW039, uncontrolled asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
704 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QAW039
Arm Type
Active Comparator
Arm Description
QAW039 once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
QAW039
Intervention Description
QAW039 once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily
Primary Outcome Measure Information:
Title
Change From Baseline in Pre-dose FEV1
Description
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Daytime Asthma Symptom Score
Description
Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score is calculated for the responses to 4 questions.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Number of Puffs of SABA Taken Per Day
Description
Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily - at the same time each morning and each evening, approximately 12 hours apart.
Time Frame
Baseline (daily mean for up to three weeks prior to baseline visit) and Week 12 (daily mean post baseline up to Week 12)
Title
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score
Description
AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Andalusia
State/Province
Alabama
ZIP/Postal Code
36420
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United States
Facility Name
Novartis Investigative Site
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Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
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United States
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Novartis Investigative Site
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Tucson
State/Province
Arizona
ZIP/Postal Code
85745
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United States
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Novartis Investigative Site
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Los Angeles
State/Province
California
ZIP/Postal Code
90048
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United States
Facility Name
Novartis Investigative Site
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Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Novartis Investigative Site
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
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City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
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Novartis Investigative Site
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San Diego
State/Province
California
ZIP/Postal Code
92120
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United States
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San Jose
State/Province
California
ZIP/Postal Code
95117
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United States
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Stockton
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California
ZIP/Postal Code
95207
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United States
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Colorado Springs
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Colorado
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80907
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United States
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Denver
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Colorado
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80230
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United States
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Lafayette
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Colorado
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80026
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United States
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Miami Gardens
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Florida
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33169
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United States
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Miami
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Florida
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33176
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United States
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Tallahassee
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Florida
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32308
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United States
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Winter Park
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Florida
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32789
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United States
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Paducah
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Kentucky
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42001
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United States
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Columbia
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Maryland
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21044
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United States
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White Marsh
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Maryland
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21162
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United States
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North Dartmouth
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Massachusetts
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02747-3322
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United States
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Ann Arbor
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Michigan
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48106
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United States
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Minneapolis
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Minnesota
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55402
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United States
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Rochester
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Minnesota
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55905
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United States
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Saint Charles
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Missouri
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63301
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United States
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Saint Louis
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Missouri
ZIP/Postal Code
63110
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United States
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Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
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United States
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Warrensburg
State/Province
Missouri
ZIP/Postal Code
64093
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United States
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Omaha
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Nebraska
ZIP/Postal Code
68134
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United States
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Brooklyn
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New York
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11235
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United States
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Raleigh
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27607
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Cincinnati
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Columbus
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Ohio
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United States
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Marion
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Ohio
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United States
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Mayfield Heights
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Ohio
ZIP/Postal Code
44124
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United States
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Tulsa
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Oklahoma
ZIP/Postal Code
74136
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United States
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Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
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United States
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Novartis Investigative Site
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Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
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United States
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Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
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United States
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Novartis Investigative Site
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Dallas
State/Province
Texas
ZIP/Postal Code
75231
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United States
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New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
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United States
Facility Name
Novartis Investigative Site
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San Antonio
State/Province
Texas
ZIP/Postal Code
78205
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United States
Facility Name
Novartis Investigative Site
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
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United States
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Novartis Investigative Site
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Newport News
State/Province
Virginia
ZIP/Postal Code
23606
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United States
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Novartis Investigative Site
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Spokane
State/Province
Washington
ZIP/Postal Code
99204
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United States
Facility Name
Novartis Investigative Site
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Goiania
State/Province
GO
ZIP/Postal Code
74110-030
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Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
Porto Alegre RS
ZIP/Postal Code
90610 000
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Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
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Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
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Brazil
Facility Name
Novartis Investigative Site
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89030101
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Brazil
Facility Name
Novartis Investigative Site
City
Sao Bernardo do Campo
State/Province
SP
ZIP/Postal Code
09715 090
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Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05437 010
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Brazil
Facility Name
Novartis Investigative Site
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Sorocaba
State/Province
SP
Country
Brazil
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Novartis Investigative Site
City
Pleven
ZIP/Postal Code
5800
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Bulgaria
Facility Name
Novartis Investigative Site
City
Ruse
ZIP/Postal Code
7002
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Bulgaria
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Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1000
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Bulgaria
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Novartis Investigative Site
City
Stara Zagora
ZIP/Postal Code
6000
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Bulgaria
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Kingston
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Ontario
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K7L 2V7
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Canada
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Novartis Investigative Site
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Toronto
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Ontario
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M6H 3M2
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Canada
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Novartis Investigative Site
City
Toronto
State/Province
Ontario
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M9V 4B4
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Canada
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City
Windsor
State/Province
Ontario
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Canada
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Ibague
State/Province
Tolima
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Colombia
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Novartis Investigative Site
City
Bogota DC
ZIP/Postal Code
110221
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Colombia
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Novartis Investigative Site
City
Bogota
ZIP/Postal Code
110111
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Colombia
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Novartis Investigative Site
City
Bucaramanga
Country
Colombia
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Novartis Investigative Site
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Berlin
ZIP/Postal Code
10367
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Germany
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Novartis Investigative Site
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Erlangen
ZIP/Postal Code
91052
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Germany
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Novartis Investigative Site
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Frankfurt
ZIP/Postal Code
60389
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Germany
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Novartis Investigative Site
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Halle
ZIP/Postal Code
06108
Country
Germany
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Novartis Investigative Site
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Hamburg
ZIP/Postal Code
20354
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Germany
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Novartis Investigative Site
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Hannover
ZIP/Postal Code
30167
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Germany
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Novartis Investigative Site
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Leipzig
ZIP/Postal Code
04357
Country
Germany
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Novartis Investigative Site
City
Lubeck
ZIP/Postal Code
23552
Country
Germany
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Novartis Investigative Site
City
Hajdunanas
State/Province
HUN
ZIP/Postal Code
4080
Country
Hungary
Facility Name
Novartis Investigative Site
City
Kapuvár
State/Province
HUN
ZIP/Postal Code
9330
Country
Hungary
Facility Name
Novartis Investigative Site
City
Puspokladany
State/Province
HUN
ZIP/Postal Code
4150
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Novartis Investigative Site
City
Pecs
ZIP/Postal Code
7635
Country
Hungary
Facility Name
Novartis Investigative Site
City
Siofok
ZIP/Postal Code
8600
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szigetszentmiklos
ZIP/Postal Code
H-2310
Country
Hungary
Facility Name
Novartis Investigative Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 060
Country
India
Facility Name
Novartis Investigative Site
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390022
Country
India
Facility Name
Novartis Investigative Site
City
Nashik
State/Province
Maharastra
ZIP/Postal Code
422007
Country
India
Facility Name
Novartis Investigative Site
City
Bikaner
State/Province
Rajasthan
ZIP/Postal Code
334 001
Country
India
Facility Name
Novartis Investigative Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641 045
Country
India
Facility Name
Novartis Investigative Site
City
DehraDun
State/Province
Uttarakhand
ZIP/Postal Code
248001
Country
India
Facility Name
Novartis Investigative Site
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
Country
Israel
Facility Name
Novartis Investigative Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Novartis Investigative Site
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novartis Investigative Site
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56124
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Novartis Investigative Site
City
Wonju
State/Province
Gangwon-do
ZIP/Postal Code
26427
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Hwaseong si
State/Province
Gyeonggi Do
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Suwon si
State/Province
Gyeonggi Do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Bucheon-Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Seocho Gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Daegu
ZIP/Postal Code
705703
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Cercado De Lima
State/Province
Lima
ZIP/Postal Code
01
Country
Peru
Facility Name
Novartis Investigative Site
City
San Isidro
State/Province
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Novartis Investigative Site
City
San Martin de Porres
State/Province
Lima
ZIP/Postal Code
31
Country
Peru
Facility Name
Novartis Investigative Site
City
Cusco
ZIP/Postal Code
84
Country
Peru
Facility Name
Novartis Investigative Site
City
Lima
ZIP/Postal Code
1
Country
Peru
Facility Name
Novartis Investigative Site
City
Piura
ZIP/Postal Code
2000
Country
Peru
Facility Name
Novartis Investigative Site
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Chelyabinsk
ZIP/Postal Code
454021
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
109544
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
N.Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Penza
ZIP/Postal Code
440067
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Perm
ZIP/Postal Code
614068
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ryazan
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint-Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Stavropol
ZIP/Postal Code
355000
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Marbella
State/Province
Andalucia
ZIP/Postal Code
29603
Country
Spain
Facility Name
Novartis Investigative Site
City
Laredo
State/Province
Cantabria
ZIP/Postal Code
39770
Country
Spain
Facility Name
Novartis Investigative Site
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Vic
ZIP/Postal Code
08500
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08540
Country
Spain
Facility Name
Novartis Investigative Site
City
Girona
ZIP/Postal Code
17005
Country
Spain
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
ZIP/Postal Code
1506
Country
Spain
Facility Name
Novartis Investigative Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Novartis Investigative Site
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Umea
ZIP/Postal Code
907 40
Country
Sweden
Facility Name
Novartis Investigative Site
City
Visby
ZIP/Postal Code
621 50
Country
Sweden
Facility Name
Novartis Investigative Site
City
Bab saadoun
ZIP/Postal Code
1007
Country
Tunisia
Facility Name
Novartis Investigative Site
City
Hai Phong
ZIP/Postal Code
180000
Country
Vietnam
Facility Name
Novartis Investigative Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Novartis Investigative Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=594
Description
A Plain Language Trial Summary is available on novartisclinicaltrials.com

Learn more about this trial

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

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