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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
  • 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 at Week 12
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 will be calculated for the responses to 4 questions.
Change From Baseline in Daily Use of SABA
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 (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
NCT03215758
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
November 1, 2017 (Actual)
Primary Completion Date
July 2, 2019 (Actual)
Study Completion Date
July 30, 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
675 (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 at Week 12
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
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 will be calculated for the responses to 4 questions.
Time Frame
12 weeks
Title
Change From Baseline in Daily Use of SABA
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
12 weeks
Title
Change From Baseline in Asthma Quality of Life (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
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
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Facility Name
Novartis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Novartis Investigative Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Novartis Investigative Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Novartis Investigative Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Novartis Investigative Site
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Novartis Investigative Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Novartis Investigative Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Novartis Investigative Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novartis Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Novartis Investigative Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Novartis Investigative Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Novartis Investigative Site
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Novartis Investigative Site
City
Dacula
State/Province
Georgia
ZIP/Postal Code
30019
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United States
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Novartis Investigative Site
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Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
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United States
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Lihue
State/Province
Hawaii
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96766
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United States
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Overland Park
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Kansas
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66210
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United States
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Novartis Investigative Site
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Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
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United States
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Columbia
State/Province
Missouri
ZIP/Postal Code
65203
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United States
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City
Rolla
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Missouri
ZIP/Postal Code
65401
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United States
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Missoula
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Montana
ZIP/Postal Code
59808
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United States
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Bellevue
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Nebraska
ZIP/Postal Code
68123
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United States
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La Vista
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Nebraska
ZIP/Postal Code
68128
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United States
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Skillman
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New Jersey
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08558
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United States
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Asheville
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North Carolina
ZIP/Postal Code
28801
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United States
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Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
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United States
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City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
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United States
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City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
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Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
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United States
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Eugene
State/Province
Oregon
ZIP/Postal Code
97401-4043
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United States
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Medford
State/Province
Oregon
ZIP/Postal Code
97504
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United States
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Portland
State/Province
Oregon
ZIP/Postal Code
97213
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United States
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
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United States
Facility Name
Novartis Investigative Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Novartis Investigative Site
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
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United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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United States
Facility Name
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City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
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Fort Worth
State/Province
Texas
ZIP/Postal Code
76109
Country
United States
Facility Name
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City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4379
Country
United States
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Novartis Investigative Site
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
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United States
Facility Name
Novartis Investigative Site
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
1888
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1122AAK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425BEN
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Novartis Investigative Site
City
Lanus
State/Province
Buenos Aires
ZIP/Postal Code
B8000XAV
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Rosa
State/Province
La Pampa
ZIP/Postal Code
6300
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
State/Province
Nueve De Julio
ZIP/Postal Code
B6500BWQ
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
State/Province
Rosario
ZIP/Postal Code
S2000DBS
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000BRH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000JKR
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IFL
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1125ABE
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cordoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mendoza
ZIP/Postal Code
M5500CBA
Country
Argentina
Facility Name
Novartis Investigative Site
City
Salta
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Peine
State/Province
Niedersachsen
ZIP/Postal Code
31224
Country
Germany
Facility Name
Novartis Investigative Site
City
Cottbus
State/Province
Sachsen
ZIP/Postal Code
03050
Country
Germany
Facility Name
Novartis Investigative Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Novartis Investigative Site
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Novartis Investigative Site
City
Furstenwalde
ZIP/Postal Code
15517
Country
Germany
Facility Name
Novartis Investigative Site
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Novartis Investigative Site
City
Lubeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Novartis Investigative Site
City
Prien A Chiemsee
ZIP/Postal Code
83209
Country
Germany
Facility Name
Novartis Investigative Site
City
Rudersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Novartis Investigative Site
City
Schleswig
ZIP/Postal Code
24837
Country
Germany
Facility Name
Novartis Investigative Site
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Novartis Investigative Site
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
Novartis Investigative Site
City
Budaors
State/Province
HUN
ZIP/Postal Code
2040
Country
Hungary
Facility Name
Novartis Investigative Site
City
Ajka
ZIP/Postal Code
8400
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Novartis Investigative Site
City
Godollo
ZIP/Postal Code
2100
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
6722
Country
Hungary
Facility Name
Novartis Investigative Site
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Novartis Investigative Site
City
Rio De Janeiro
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Novartis Investigative Site
City
Lipa City
State/Province
Batangas
ZIP/Postal Code
4217
Country
Philippines
Facility Name
Novartis Investigative Site
City
Quezon City
State/Province
Manila
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Novartis Investigative Site
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Novartis Investigative Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Novartis Investigative Site
City
Riyadh
State/Province
SAU
ZIP/Postal Code
11525
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Jeddah
ZIP/Postal Code
21423
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Bardejov
State/Province
Slovak Republic
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kezmarok
ZIP/Postal Code
060 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Michalovce
ZIP/Postal Code
071 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Spisska Nova Ves
ZIP/Postal Code
052 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Zilina
ZIP/Postal Code
01207
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Tygerberg
State/Province
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Novartis Investigative Site
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Novartis Investigative Site
City
Chatsworth
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Novartis Investigative Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Novartis Investigative Site
City
Pretoria
ZIP/Postal Code
0183
Country
South Africa
Facility Name
Novartis Investigative Site
City
Istanbul
State/Province
TUR
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Novartis Investigative Site
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34020
Country
Turkey
Facility Name
Novartis Investigative Site
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Facility Name
Novartis Investigative Site
City
Talas / Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Novartis Investigative Site
City
Yenisehir/Izmir
ZIP/Postal Code
35110
Country
Turkey

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=593
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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