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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
675

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Argentina
      • Buenos Aires, Argentina, C1125ABE
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1012AAR
        • Novartis Investigative Site
      • Córdoba, Argentina, X5003DCE
        • Novartis Investigative Site
      • Mendoza, Argentina, 5500
        • Novartis Investigative Site
      • Mendoza, Argentina, M5500CBA
        • Novartis Investigative Site
      • Salta, Argentina, 4000
        • Novartis Investigative Site
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, 1888
        • Novartis Investigative Site
      • CABA, Buenos Aires, Argentina, C1056ABJ
        • Novartis Investigative Site
      • CABA, Buenos Aires, Argentina, C1122AAK
        • Novartis Investigative Site
      • CABA, Buenos Aires, Argentina, C1425BEN
        • Novartis Investigative Site
      • CABA, Buenos Aires, Argentina, C1426ABP
        • Novartis Investigative Site
      • Lanús, Buenos Aires, Argentina, B8000XAV
        • Novartis Investigative Site
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Novartis Investigative Site
    • La Pampa Province
      • Santa Rosa, La Pampa Province, Argentina, 6300
        • Novartis Investigative Site
    • Nueve De Julio
      • Buenos Aires, Nueve De Julio, Argentina, B6500BWQ
        • Novartis Investigative Site
    • Rosario
      • Santa Fe, Rosario, Argentina, S2000DBS
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000JKR
        • Novartis Investigative Site
      • Rosario, Santa Fe Province, Argentina, S2000BRH
        • Novartis Investigative Site
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IFL
        • Novartis Investigative Site
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Novartis Investigative Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • Novartis Investigative Site
      • Bamberg, Germany, 96049
        • Novartis Investigative Site
      • Berlin, Germany, 12203
        • Novartis Investigative Site
      • Berlin, Germany, 12157
        • Novartis Investigative Site
      • Fürstenwalde, Germany, 15517
        • Novartis Investigative Site
      • Gauting, Germany, 82131
        • Novartis Investigative Site
      • Leipzig, Germany, 04275
        • Novartis Investigative Site
      • Lübeck, Germany, 23552
        • Novartis Investigative Site
      • Prien A Chiemsee, Germany, 83209
        • Novartis Investigative Site
      • Rudersdorf, Germany, 15562
        • Novartis Investigative Site
      • Schleswig, Germany, 24837
        • Novartis Investigative Site
      • Schwerin, Germany, 19055
        • Novartis Investigative Site
      • Witten, Germany, 58452
        • Novartis Investigative Site
    • Lower Saxony
      • Peine, Lower Saxony, Germany, 31224
        • Novartis Investigative Site
    • Saxony
      • Cottbus, Saxony, Germany, 03050
        • Novartis Investigative Site
  • Hungary
      • Ajka, Hungary, 8400
        • Novartis Investigative Site
      • Budapest, Hungary, 1125
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Novartis Investigative Site
      • Gödöllő, Hungary, 2100
        • Novartis Investigative Site
      • Szeged, Hungary, 6722
        • Novartis Investigative Site
    • HUN
      • Budaörs, HUN, Hungary, 2040
        • Novartis Investigative Site
  • Mexico
      • Río de Janeiro, Mexico, 06700
        • Novartis Investigative Site
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80230
        • Novartis Investigative Site
  • Philippines
      • Iloilo City, Philippines, 5000
        • Novartis Investigative Site
      • Manila, Philippines, 1000
        • Novartis Investigative Site
    • Batangas
      • Lipa City, Batangas, Philippines, 4217
        • Novartis Investigative Site
    • Manila
      • Quezon City, Manila, Philippines, 1100
        • Novartis Investigative Site
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21423
        • Novartis Investigative Site
    • SAU
      • Riyadh, SAU, Saudi Arabia, 11525
        • Novartis Investigative Site
  • Slovakia
      • Kežmarok, Slovakia, 060 01
        • Novartis Investigative Site
      • Michalovce, Slovakia, 071 01
        • Novartis Investigative Site
      • Poprad, Slovakia, 058 01
        • Novartis Investigative Site
      • Prešov, Slovakia, 080 01
        • Novartis Investigative Site
      • Spišská Nová Ves, Slovakia, 052 01
        • Novartis Investigative Site
      • Žilina, Slovakia, 01207
        • Novartis Investigative Site
    • Slovak Republic
      • Bardejov, Slovak Republic, Slovakia, 085 01
        • Novartis Investigative Site
  • South Africa
      • Cape Town, South Africa, 7500
        • Novartis Investigative Site
      • Chatsworth, South Africa, 4092
        • Novartis Investigative Site
      • Durban, South Africa, 4001
        • Novartis Investigative Site
      • Pretoria, South Africa, 0183
        • Novartis Investigative Site
    • Cape Town
      • Tygerberg, Cape Town, South Africa, 7505
        • Novartis Investigative Site
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01330
        • Novartis Investigative Site
      • Ankara, Turkey (Türkiye), 06100
        • Novartis Investigative Site
      • Istanbul, Turkey (Türkiye), 34020
        • Novartis Investigative Site
      • Mersin, Turkey (Türkiye), 33343
        • Novartis Investigative Site
      • Talas / Kayseri, Turkey (Türkiye), 38039
        • Novartis Investigative Site
      • Yenisehir/Izmir, Turkey (Türkiye), 35110
        • Novartis Investigative Site
    • TUR
      • Istanbul, TUR, Turkey (Türkiye), 34098
        • Novartis Investigative Site
  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Novartis Investigative Site
      • Phoenix, Arizona, United States, 85006
        • Novartis Investigative Site
    • California
      • Huntington Beach, California, United States, 92647
        • Novartis Investigative Site
      • Long Beach, California, United States, 90808
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90025
        • Novartis Investigative Site
      • Mission Viejo, California, United States, 92691
        • Novartis Investigative Site
      • Mountain View, California, United States, 94040
        • Novartis Investigative Site
      • Orange, California, United States, 92868
        • Novartis Investigative Site
      • Roseville, California, United States, 95661
        • Novartis Investigative Site
      • Walnut Creek, California, United States, 94598
        • Novartis Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • Novartis Investigative Site
    • Florida
      • Tamarac, Florida, United States, 33321
        • Novartis Investigative Site
      • Winter Park, Florida, United States, 32789
        • Novartis Investigative Site
    • Georgia
      • Albany, Georgia, United States, 31707
        • Novartis Investigative Site
      • Dacula, Georgia, United States, 30019
        • Novartis Investigative Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novartis Investigative Site
      • Lihue, Hawaii, United States, 96766
        • Novartis Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Novartis Investigative Site
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Novartis Investigative Site
      • Rolla, Missouri, United States, 65401
        • Novartis Investigative Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Novartis Investigative Site
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Novartis Investigative Site
      • La Vista, Nebraska, United States, 68128
        • Novartis Investigative Site
    • New Jersey
      • Skillman, New Jersey, United States, 08558
        • Novartis Investigative Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Novartis Investigative Site
      • Gastonia, North Carolina, United States, 28054
        • Novartis Investigative Site
      • High Point, North Carolina, United States, 27262
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Novartis Investigative Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Novartis Investigative Site
    • Oregon
      • Eugene, Oregon, United States, 97401-4043
        • Novartis Investigative Site
      • Medford, Oregon, United States, 97504
        • Novartis Investigative Site
      • Portland, Oregon, United States, 97213
        • Novartis Investigative Site
      • Portland, Oregon, United States, 97220
        • Novartis Investigative Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Novartis Investigative Site
    • Texas
      • Boerne, Texas, United States, 78006
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75231
        • Novartis Investigative Site
      • El Paso, Texas, United States, 79903
        • Novartis Investigative Site
      • Fort Worth, Texas, United States, 76109
        • Novartis Investigative Site
      • McKinney, Texas, United States, 75069
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, United States, 98122-4379
        • Novartis Investigative Site
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pre-dose FEV1 at Week 12
Time Frame: 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.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Daytime Asthma Symptom Score
Time Frame: 12 weeks
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.
12 weeks
Change From Baseline in Daily Use of SABA
Time Frame: 12 weeks
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.
12 weeks
Change From Baseline in Asthma Quality of Life (AQLQ+12) Score
Time Frame: 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.
Week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 2, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQAW039A2316
  • 2017-001273-16 (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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