AsthmaPhase 3NCT03226392

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

A Phase 3 study testing QAW039 in people with Asthma, run by Novartis Pharmaceuticals at 142 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: QAW039
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 704 participants
Where: 142 sitesin 18 countries
Study dates: 31 Oct 2017to 1 Aug 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

142 sites in 18 countries.

Country

City, postcode or hospital

142 sites in 18 countries

United States45 sites

Novartis Investigative Site
Altoona, Pennsylvania, 16602
Novartis Investigative Site
Andalusia, Alabama, 36420
Novartis Investigative Site
Ann Arbor, Michigan, 48106
Novartis Investigative Site
Birmingham, Alabama, 35209
Novartis Investigative Site
Brooklyn, New York, 11235
Novartis Investigative Site
Cincinnati, Ohio, 45245
Novartis Investigative Site
Colorado Springs, Colorado, 80907
Novartis Investigative Site
Columbia, Maryland, 21044
Novartis Investigative Site
Columbus, Ohio, 43215
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Denver, Colorado, 80230
Novartis Investigative Site
Lafayette, Colorado, 80026
Novartis Investigative Site
Los Angeles, California, 90048
Novartis Investigative Site
Marion, Ohio, 43302
Novartis Investigative Site
Mayfield Heights, Ohio, 44124
Novartis Investigative Site
Miami, Florida, 33176
Novartis Investigative Site
Miami Gardens, Florida, 33169
Novartis Investigative Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464
Novartis Investigative Site
Murray, Utah, 84107
Novartis Investigative Site
New Braunfels, Texas, 78130
Novartis Investigative Site
Newport Beach, California, 92663
Novartis Investigative Site
Newport News, Virginia, 23606
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747-3322
Novartis Investigative Site
Omaha, Nebraska, 68134
Novartis Investigative Site
Paducah, Kentucky, 42001
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15241
Novartis Investigative Site
Raleigh, North Carolina, 27607
Novartis Investigative Site
Rochester, Minnesota, 55905
Novartis Investigative Site
Rolling Hills Estates, California, 90274
Novartis Investigative Site
Saint Charles, Missouri, 63301
Novartis Investigative Site
San Antonio, Texas, 78205
Novartis Investigative Site
San Diego, California, 92117
Novartis Investigative Site
San Diego, California, 92120
Novartis Investigative Site
San Jose, California, 95117
Novartis Investigative Site
Spokane, Washington, 99204
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
Stockton, California, 95207
Novartis Investigative Site
Tallahassee, Florida, 32308
Novartis Investigative Site
Tucson, Arizona, 85745
Novartis Investigative Site
Tulsa, Oklahoma, 74136
Novartis Investigative Site
Warrensburg, Missouri, 64093
Novartis Investigative Site
White Marsh, Maryland, 21162
Novartis Investigative Site
Winter Park, Florida, 32789

Other trials in United States

Russia14 sites

Novartis Investigative Site
Barnaul, 656024
Novartis Investigative Site
Chelyabinsk, 454021
Novartis Investigative Site
Moscow, 109544
Novartis Investigative Site
Moscow, 115478
Novartis Investigative Site
N.Novgorod, 603126
Novartis Investigative Site
Penza, 440067
Novartis Investigative Site
Perm, 614068
Novartis Investigative Site
Ryazan, 390039
Novartis Investigative Site
Saint Petersburg, 191186
Novartis Investigative Site
Saint Petersburg, 194354
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Stavropol, 355000
Novartis Investigative Site
Yaroslavl, 150054
Novartis Investigative Site
Yekaterinburg, 620109

Other trials in Russia

Spain10 sites

Novartis Investigative Site
Barcelona, Vic, 08500
Novartis Investigative Site
Barcelona, 08006
Novartis Investigative Site
Barcelona, 08540
Novartis Investigative Site
Girona, 17005
Novartis Investigative Site
Laredo, Cantabria, 39770
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Marbella, Andalusia, 29603
Novartis Investigative Site
Pozuelo de Alarcón, Madrid, 28223
Novartis Investigative Site
Santiago de Compostela, 1506
Novartis Investigative Site
Zaragoza, 50009

Other trials in Spain

South Korea9 sites

Novartis Investigative Site
Bucheon-si, Gyeonggi-do, 14584
Novartis Investigative Site
Daegu, 705703
Novartis Investigative Site
Hwaseong-si, Gyeonggi-do, 18450
Novartis Investigative Site
Incheon, 21431
Novartis Investigative Site
Seoul, Korea, 03312
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Novartis Investigative Site
Seoul, 05505
Novartis Investigative Site
Suwon, Gyeonggi-do, 16499
Novartis Investigative Site
Wŏnju, Gangwon-do, 26427

Other trials in South Korea

Brazil8 sites

Novartis Investigative Site
Blumenau, Santa Catarina, 89030101
Novartis Investigative Site
Goiânia, Goiás, 74110-030
Novartis Investigative Site
Porto Alegre, Porto Alegre RS, 90610 000
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90020-090
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90610-000
Novartis Investigative Site
São Bernardo do Campo, São Paulo, 09715 090
Novartis Investigative Site
São Paulo, São Paulo, 05437 010
Novartis Investigative Site
Sorocaba, São Paulo

Other trials in Brazil

Germany8 sites

Novartis Investigative Site
Berlin, 10367
Novartis Investigative Site
Erlangen, 91052
Novartis Investigative Site
Frankfurt, 60389
Novartis Investigative Site
Halle, 06108
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Hanover, 30167
Novartis Investigative Site
Leipzig, 04357
Novartis Investigative Site
Lübeck, 23552

Other trials in Germany

Hungary7 sites

Novartis Investigative Site
Budapest, 1106
Novartis Investigative Site
Hajdúnánás, HUN, 4080
Novartis Investigative Site
Kapuvár, HUN, 9330
Novartis Investigative Site
Pécs, 7635
Novartis Investigative Site
Püspökladány, HUN, 4150
Novartis Investigative Site
Siófok, 8600
Novartis Investigative Site
Szigetszentmiklós, H-2310

Other trials in Hungary

India6 sites

Novartis Investigative Site
Ahmedabad, Gujarat, 380 060
Novartis Investigative Site
Bikaner, Rajasthan, 334 001
Novartis Investigative Site
Coimbatore, Tamil Nadu, 641 045
Novartis Investigative Site
Dehradun, Uttarakhand, 248001
Novartis Investigative Site
Nashik, Maharashtra, 422007
Novartis Investigative Site
Vadodara, Gujarat, 390022

Other trials in India

Peru6 sites

Novartis Investigative Site
Cusco, 84
Novartis Investigative Site
Lima, 1
Novartis Investigative Site
Lima Cercado, Lima region, 01
Novartis Investigative Site
Piura, 2000
Novartis Investigative Site
San Isidro, Lima region, 27
Novartis Investigative Site
San Martín de Porres, Lima region, 31

Other trials in Peru

Italy5 sites

Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Milan, 20157
Novartis Investigative Site
Pisa, PI, 56124
Novartis Investigative Site
Rozzano, MI, 20089

Other trials in Italy

Bulgaria4 sites

Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Rousse, 7002
Novartis Investigative Site
Sofia, 1000
Novartis Investigative Site
Stara Zagora, 6000

Other trials in Bulgaria

Canada4 sites

Novartis Investigative Site
Kingston, Ontario, K7L 2V7
Novartis Investigative Site
Toronto, Ontario, M6H 3M2
Novartis Investigative Site
Toronto, Ontario, M9V 4B4
Novartis Investigative Site
Windsor, Ontario, N8X 5A6

Other trials in Canada

Colombia4 sites

Novartis Investigative Site
Bogotá, 110111
Novartis Investigative Site
Bogota DC, 110221
Novartis Investigative Site
Bucaramanga
Novartis Investigative Site
Ibague, Tolima Department, 730006

Other trials in Colombia

Israel4 sites

Novartis Investigative Site
Ashkelon, 78278
Novartis Investigative Site
Haifa, 3436212
Novartis Investigative Site
Jerusalem
Novartis Investigative Site
Rehovot, 76100

Other trials in Israel

Sweden3 sites

Novartis Investigative Site
Lund, SE-221 85
Novartis Investigative Site
Umeå, 907 40
Novartis Investigative Site
Visby, 621 50

Other trials in Sweden

Vietnam3 sites

Novartis Investigative Site
Haiphong, 180000
Novartis Investigative Site
Hanoi, 100000
Novartis Investigative Site
Ho Chi Minh City, 700000

Other trials in Vietnam

Puerto Rico1 site

Novartis Investigative Site
San Juan, 00909

Other trials in Puerto Rico

Tunisia1 site

Novartis Investigative Site
Bab Saadoun, 1007

Other trials in Tunisia

About this study

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

Conditions: Asthma
Being tested: QAW039, Placebo
Keywords: QAW039, uncontrolled asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QAW039Drug
QAW039 once daily
PlaceboDrug
Placebo once daily

Study groups in NCT03226392
Study group	Role	What they receive
QAW039	Active comparator	QAW039 once daily Receives: Drug: QAW039
Placebo	Placebo comparator	Placebo once daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 12

Secondary outcomes (3)

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.
Measured: Baseline and Week 12
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.
Measured: 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
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.
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 20171 Aug 2019

First posted21 Jul 2017
Study start31 Oct 2017
Primary completion5 Jul 2019
Study completion1 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 704 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03226392
Sponsor's protocol ID: CQAW039A2317
Other IDs: 2017-001272-40, 2017
Status last verified: Dec 2025
First submitted: 11 Jul 2017
Last updated: 13 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03226392
Acronym / sponsor ID: CQAW039A2317
Conditions: Asthma
Keywords: QAW039, uncontrolled asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 704 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 31 Oct 2017 (actual)
Primary completion: 5 Jul 2019 (actual)
Study completion: 1 Aug 2019 (actual)
First posted: 21 Jul 2017 (actual)
Results: Posted 28 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
QAW039	Active comparator	Drug: QAW039QAW039 once daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo once daily

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QAW039QAW039 once daily	Drug	QAW039
PlaceboPlacebo once daily	Drug	Placebo

Primary outcome

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.

3 secondary outcomes

Change From Baseline in Daytime Asthma Symptom Score
Time frame: 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)
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 28 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QAW039	352	341
Placebo	352	344

Primary outcome: Change From Baseline in Pre-dose FEV1

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: Liters

Measure	QAW039 n = 352	Placebo n = 350
Value	0.126 (0.00177)	0.157 (0.0177)

QAW039 vs Placebo: Mean Difference (Net): -0.031 (95% CI -0.080 to 0.018), p = 0.214, ANCOVA

Population analysed: Full Analysis Set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: After signing informed consent to 30 days after last dose, assessed up to 16 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QAW039 150 mg	7 of 352 (2%)	94 of 352 (26.7%)	0 of 352
Placebo	3 of 350 (0.9%)	116 of 350 (33.1%)	0 of 350

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
A Pediatric Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

142 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QAW039 in people with Asthma, run by Novartis Pharmaceuticals at 142 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Russia, Spain, South Korea, Brazil and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Pre-dose FEV1 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03226392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.