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

December 18, 2025 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

704

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Goiás
      • Goiânia, Goiás, Brazil, 74110-030
        • Novartis Investigative Site
    • Porto Alegre RS
      • Porto Alegre, Porto Alegre RS, Brazil, 90610 000
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Novartis Investigative Site
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89030101
        • Novartis Investigative Site
    • São Paulo
      • Sorocaba, São Paulo, Brazil
        • Novartis Investigative Site
      • São Bernardo do Campo, São Paulo, Brazil, 09715 090
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 05437 010
        • Novartis Investigative Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Rousse, Bulgaria, 7002
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1000
        • Novartis Investigative Site
      • Stara Zagora, Bulgaria, 6000
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M6H 3M2
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Novartis Investigative Site
      • Windsor, Ontario, Canada, N8X 5A6
        • Novartis Investigative Site
  • Colombia
      • Bogota DC, Colombia, 110221
        • Novartis Investigative Site
      • Bogotá, Colombia, 110111
        • Novartis Investigative Site
      • Bucaramanga, Colombia
        • Novartis Investigative Site
    • Tolima Department
      • Ibagué, Tolima Department, Colombia, 730006
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10367
        • Novartis Investigative Site
      • Erlangen, Germany, 91052
        • Novartis Investigative Site
      • Frankfurt, Germany, 60389
        • Novartis Investigative Site
      • Halle, Germany, 06108
        • Novartis Investigative Site
      • Hamburg, Germany, 20354
        • Novartis Investigative Site
      • Hanover, Germany, 30167
        • Novartis Investigative Site
      • Leipzig, Germany, 04357
        • Novartis Investigative Site
      • Lübeck, Germany, 23552
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1106
        • Novartis Investigative Site
      • Pécs, Hungary, 7635
        • Novartis Investigative Site
      • Siófok, Hungary, 8600
        • Novartis Investigative Site
      • Szigetszentmiklós, Hungary, H-2310
        • Novartis Investigative Site
    • HUN
      • Hajdúnánás, HUN, Hungary, 4080
        • Novartis Investigative Site
      • Kapuvár, HUN, Hungary, 9330
        • Novartis Investigative Site
      • Püspökladány, HUN, Hungary, 4150
        • Novartis Investigative Site
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 060
        • Novartis Investigative Site
      • Vadodara, Gujarat, India, 390022
        • Novartis Investigative Site
    • Maharashtra
      • Nashik, Maharashtra, India, 422007
        • Novartis Investigative Site
    • Rajasthan
      • Bikaner, Rajasthan, India, 334 001
        • Novartis Investigative Site
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641 045
        • Novartis Investigative Site
    • Uttarakhand
      • Dehradun, Uttarakhand, India, 248001
        • Novartis Investigative Site
  • Israel
      • Ashkelon, Israel, 78278
        • Novartis Investigative Site
      • Haifa, Israel, 3436212
        • Novartis Investigative Site
      • Jerusalem, Israel
        • Novartis Investigative Site
      • Rehovot, Israel, 76100
        • Novartis Investigative Site
  • Italy
      • Milan, Italy, 20157
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Novartis Investigative Site
    • FI
      • Florence, FI, Italy, 50134
        • Novartis Investigative Site
    • MI
      • Rozzano, MI, Italy, 20089
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56124
        • Novartis Investigative Site
  • Peru
      • Cusco, Peru, 84
        • Novartis Investigative Site
      • Lima, Peru, 1
        • Novartis Investigative Site
      • Piura, Peru, 2000
        • Novartis Investigative Site
    • Lima region
      • Lima Cercado, Lima region, Peru, 01
        • Novartis Investigative Site
      • San Isidro, Lima region, Peru, 27
        • Novartis Investigative Site
      • San Martín de Porres, Lima region, Peru, 31
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Novartis Investigative Site
  • Russia
      • Barnaul, Russia, 656024
        • Novartis Investigative Site
      • Chelyabinsk, Russia, 454021
        • Novartis Investigative Site
      • Moscow, Russia, 115478
        • Novartis Investigative Site
      • Moscow, Russia, 109544
        • Novartis Investigative Site
      • N.Novgorod, Russia, 603126
        • Novartis Investigative Site
      • Penza, Russia, 440067
        • Novartis Investigative Site
      • Perm, Russia, 614068
        • Novartis Investigative Site
      • Ryazan, Russia, 390039
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197022
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 194354
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 191186
        • Novartis Investigative Site
      • Stavropol, Russia, 355000
        • Novartis Investigative Site
      • Yaroslavl, Russia, 150054
        • Novartis Investigative Site
      • Yekaterinburg, Russia, 620109
        • Novartis Investigative Site
  • South Korea
      • Daegu, South Korea, 705703
        • Novartis Investigative Site
      • Incheon, South Korea, 21431
        • Novartis Investigative Site
      • Seoul, South Korea, 05505
        • Novartis Investigative Site
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26427
        • Novartis Investigative Site
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, South Korea, 14584
        • Novartis Investigative Site
      • Hwaseong-si, Gyeonggi-do, South Korea, 18450
        • Novartis Investigative Site
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, South Korea, 03312
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul, Seocho Gu, South Korea, 06591
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08006
        • Novartis Investigative Site
      • Barcelona, Spain, 08540
        • Novartis Investigative Site
      • Girona, Spain, 17005
        • Novartis Investigative Site
      • Santiago de Compostela, Spain, 1506
        • Novartis Investigative Site
      • Zaragoza, Spain, 50009
        • Novartis Investigative Site
    • Andalusia
      • Marbella, Andalusia, Spain, 29603
        • Novartis Investigative Site
      • Málaga, Andalusia, Spain, 29010
        • Novartis Investigative Site
    • Cantabria
      • Laredo, Cantabria, Spain, 39770
        • Novartis Investigative Site
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Novartis Investigative Site
    • Vic
      • Barcelona, Vic, Spain, 08500
        • Novartis Investigative Site
  • Sweden
      • Lund, Sweden, SE-221 85
        • Novartis Investigative Site
      • Umeå, Sweden, 907 40
        • Novartis Investigative Site
      • Visby, Sweden, 621 50
        • Novartis Investigative Site
  • Tunisia
      • Bab Saadoun, Tunisia, 1007
        • Novartis Investigative Site
  • United States
    • Alabama
      • Andalusia, Alabama, United States, 36420
        • Novartis Investigative Site
      • Birmingham, Alabama, United States, 35209
        • Novartis Investigative Site
    • Arizona
      • Tucson, Arizona, United States, 85745
        • Novartis Investigative Site
    • California
      • Los Angeles, California, United States, 90048
        • Novartis Investigative Site
      • Newport Beach, California, United States, 92663
        • Novartis Investigative Site
      • Rolling Hills Estates, California, United States, 90274
        • Novartis Investigative Site
      • San Diego, California, United States, 92120
        • Novartis Investigative Site
      • San Diego, California, United States, 92117
        • Novartis Investigative Site
      • San Jose, California, United States, 95117
        • Novartis Investigative Site
      • Stockton, California, United States, 95207
        • Novartis Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Novartis Investigative Site
      • Denver, Colorado, United States, 80230
        • Novartis Investigative Site
      • Lafayette, Colorado, United States, 80026
        • Novartis Investigative Site
    • Florida
      • Miami, Florida, United States, 33176
        • Novartis Investigative Site
      • Miami Gardens, Florida, United States, 33169
        • Novartis Investigative Site
      • Tallahassee, Florida, United States, 32308
        • Novartis Investigative Site
      • Winter Park, Florida, United States, 32789
        • Novartis Investigative Site
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Novartis Investigative Site
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Novartis Investigative Site
      • White Marsh, Maryland, United States, 21162
        • Novartis Investigative Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747-3322
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Novartis Investigative Site
      • Rochester, Minnesota, United States, 55905
        • Novartis Investigative Site
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Novartis Investigative Site
      • St Louis, Missouri, United States, 63141
        • Novartis Investigative Site
      • St Louis, Missouri, United States, 63110
        • Novartis Investigative Site
      • Warrensburg, Missouri, United States, 64093
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Novartis Investigative Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Novartis Investigative Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Novartis Investigative Site
      • Columbus, Ohio, United States, 43215
        • Novartis Investigative Site
      • Marion, Ohio, United States, 43302
        • Novartis Investigative Site
      • Mayfield Heights, Ohio, United States, 44124
        • Novartis Investigative Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Novartis Investigative Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • Novartis Investigative Site
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Novartis Investigative Site
      • New Braunfels, Texas, United States, 78130
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78205
        • Novartis Investigative Site
    • Utah
      • Murray, Utah, United States, 84107
        • Novartis Investigative Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novartis Investigative Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Novartis Investigative Site
  • Vietnam
      • Haiphong, Vietnam, 180000
        • Novartis Investigative Site
      • Hanoi, Vietnam, 100000
        • Novartis Investigative Site
      • Ho Chi Minh City, Vietnam, 700000
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
Placebo once daily
Active Comparator: QAW039
QAW039 once daily
Drug: QAW039
QAW039 once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pre-dose FEV1
Time Frame: Baseline and 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.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Daytime Asthma Symptom Score
Time Frame: Baseline and Week 12
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.
Baseline and Week 12
Change From Baseline in Number of Puffs of SABA Taken Per Day
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)
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.
Baseline (daily mean for up to three weeks prior to baseline visit) and Week 12 (daily mean post baseline up to Week 12)
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score
Time Frame: Baseline and Week 12
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.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2017

Primary Completion (Actual)

July 5, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Estimated)

January 13, 2026

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAW039A2317
  • 2017-001272-40 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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