AsthmaPhase 3NCT03215758

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 110 sites in 10 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: 675 participants
Where: 110 sitesin 10 countries
Study dates: 1 Nov 2017to 30 Jul 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

110 sites in 10 countries.

Country

City, postcode or hospital

110 sites in 10 countries

United States42 sites

Novartis Investigative Site
Albany, Georgia, 31707
Novartis Investigative Site
Asheville, North Carolina, 28801
Novartis Investigative Site
Bellevue, Nebraska, 68123
Novartis Investigative Site
Boerne, Texas, 78006
Novartis Investigative Site
Cincinnati, Ohio, 45231
Novartis Investigative Site
Columbia, Missouri, 65203
Novartis Investigative Site
Dacula, Georgia, 30019
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Denver, Colorado, 80206
Novartis Investigative Site
Edmond, Oklahoma, 73034
Novartis Investigative Site
El Paso, Texas, 79903
Novartis Investigative Site
Eugene, Oregon, 97401-4043
Novartis Investigative Site
Flagstaff, Arizona, 86001
Novartis Investigative Site
Fort Worth, Texas, 76109
Novartis Investigative Site
Gastonia, North Carolina, 28054
Novartis Investigative Site
Greenfield, Wisconsin, 53228
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Honolulu, Hawaii, 96814
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
La Vista, Nebraska, 68128
Novartis Investigative Site
Lihue, Hawaii, 96766
Novartis Investigative Site
Long Beach, California, 90808
Novartis Investigative Site
Los Angeles, California, 90025
Novartis Investigative Site
Louisville, Kentucky, 40215
Novartis Investigative Site
McKinney, Texas, 75069
Novartis Investigative Site
Medford, Oregon, 97504
Novartis Investigative Site
Mission Viejo, California, 92691
Novartis Investigative Site
Missoula, Montana, 59808
Novartis Investigative Site
Mountain View, California, 94040
Novartis Investigative Site
Orange, California, 92868
Novartis Investigative Site
Overland Park, Kansas, 66210
Novartis Investigative Site
Phoenix, Arizona, 85006
Novartis Investigative Site
Portland, Oregon, 97213
Novartis Investigative Site
Portland, Oregon, 97220
Novartis Investigative Site
Rapid City, South Dakota, 57701
Novartis Investigative Site
Rolla, Missouri, 65401
Novartis Investigative Site
Roseville, California, 95661
Novartis Investigative Site
Seattle, Washington, 98122-4379
Novartis Investigative Site
Skillman, New Jersey, 08558
Novartis Investigative Site
Tamarac, Florida, 33321
Novartis Investigative Site
Walnut Creek, California, 94598
Novartis Investigative Site
Winter Park, Florida, 32789

Other trials in United States

Argentina20 sites

Novartis Investigative Site
Berazategui, Buenos Aires, 1888
Novartis Investigative Site
Buenos Aires, Nueve De Julio, B6500BWQ
Novartis Investigative Site
Buenos Aires, C1012AAR
Novartis Investigative Site
Buenos Aires, C1125ABE
Novartis Investigative Site
CABA, Buenos Aires, C1056ABJ
Novartis Investigative Site
CABA, Buenos Aires, C1122AAK
Novartis Investigative Site
CABA, Buenos Aires, C1425BEN
Novartis Investigative Site
CABA, Buenos Aires, C1426ABP
Novartis Investigative Site
Córdoba, X5003DCE
Novartis Investigative Site
Lanus, Buenos Aires, B8000XAV
Novartis Investigative Site
Mar del Plata, Buenos Aires, 7600
Novartis Investigative Site
Mendoza, 5500
Novartis Investigative Site
Mendoza, M5500CBA
Novartis Investigative Site
Rosario, Santa Fe Province, S2000BRH
Novartis Investigative Site
Rosario, Santa Fe Province, S2000JKR
Novartis Investigative Site
Salta, 4000
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000IFL
Novartis Investigative Site
Santa Fe, Rosario, S2000DBS
Novartis Investigative Site
Santa Rosa, La Pampa Province, 6300

Other trials in Argentina

Germany15 sites

Novartis Investigative Site
Aschaffenburg, 63739
Novartis Investigative Site
Bamberg, 96049
Novartis Investigative Site
Berlin, 12157
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Cottbus, Saxony, 03050
Novartis Investigative Site
Fürstenwalde, 15517
Novartis Investigative Site
Gauting, 82131
Novartis Investigative Site
Leipzig, 04275
Novartis Investigative Site
Lübeck, 23552
Novartis Investigative Site
Peine, Lower Saxony, 31224
Novartis Investigative Site
Prien A Chiemsee, 83209
Novartis Investigative Site
Rüdersdorf, 15562
Novartis Investigative Site
Schleswig, 24837
Novartis Investigative Site
Schwerin, 19055
Novartis Investigative Site
Witten, 58452

Other trials in Germany

Slovakia7 sites

Novartis Investigative Site
Bardejov, Slovak Republic, 085 01
Novartis Investigative Site
Kežmarok, 060 01
Novartis Investigative Site
Michalovce, 071 01
Novartis Investigative Site
Poprad, 058 01
Novartis Investigative Site
Prešov, 080 01
Novartis Investigative Site
Spišská Nová Ves, 052 01
Novartis Investigative Site
Žilina, 01207

Other trials in Slovakia

Turkey (Türkiye)7 sites

Novartis Investigative Site
Adana, 01330
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Istanbul, TUR, 34098
Novartis Investigative Site
Istanbul, 34020
Novartis Investigative Site
Mersin, 33343
Novartis Investigative Site
Talas / Kayseri, 38039
Novartis Investigative Site
Yenisehir/Izmir, 35110

Other trials in Turkey (Türkiye)

Hungary6 sites

Novartis Investigative Site
Ajka, 8400
Novartis Investigative Site
Budaörs, HUN, 2040
Novartis Investigative Site
Budapest, 1125
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Gödöllő, 2100
Novartis Investigative Site
Szeged, 6722

Other trials in Hungary

South Africa5 sites

Novartis Investigative Site
Cape Town, 7500
Novartis Investigative Site
Chatsworth, 4092
Novartis Investigative Site
Durban, 4001
Novartis Investigative Site
Pretoria, 0183
Novartis Investigative Site
Tygerberg, Cape Town, 7505

Other trials in South Africa

Philippines4 sites

Novartis Investigative Site
Iloilo City, 5000
Novartis Investigative Site
Lipa City, Batangas, 4217
Novartis Investigative Site
Manila, 1000
Novartis Investigative Site
Quezon City, Manila, 1100

Other trials in Philippines

Mexico2 sites

Novartis Investigative Site
Culiacán, Sinaloa, 80230
Novartis Investigative Site
Río de Janeiro, 06700

Other trials in Mexico

Saudi Arabia2 sites

Novartis Investigative Site
Jeddah, 21423
Novartis Investigative Site
Riyadh, SAU, 11525

Other trials in Saudi Arabia

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 NCT03215758
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 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.
Measured: 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 will be calculated for the responses to 4 questions.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: Week 12

Timeline

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

1 Nov 201730 Jul 2019

First posted12 Jul 2017
Study start1 Nov 2017
Primary completion2 Jul 2019
Study completion30 Jul 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: 675 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03215758
Sponsor's protocol ID: CQAW039A2316
Other IDs: 2017-001273-16, 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

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
Asthma Control
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
Asthma

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: NCT03215758
Acronym / sponsor ID: CQAW039A2316
Conditions: Asthma
Keywords: QAW039, uncontrolled asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 675 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 1 Nov 2017 (actual)
Primary completion: 2 Jul 2019 (actual)
Study completion: 30 Jul 2019 (actual)
First posted: 12 Jul 2017 (actual)
Results: Posted 12 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 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.

3 secondary outcomes

Change From Baseline in Daytime Asthma Symptom Score
Time frame: 12 weeks
Change From Baseline in Daily Use of SABA
Time frame: 12 weeks
Change From Baseline in Asthma Quality of Life (AQLQ+12) Score
Time frame: Week 12

Results and safety

Results posted to the registry on 12 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	339	334
Placebo	336	328

Primary outcome: Change From Baseline in Pre-dose FEV1 at Week 12

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

Measure	QAW039 n = 339	Placebo n = 336
Value	0.112 (0.0167)	0.071 (0.0169)

QAW039 vs Placebo: Mean Difference (Net): 0.0238 (95% CI -0.006 to 0.088), p = 0.088, 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. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QAW039 150 mg	1 of 339 (0.3%)	94 of 339 (27.7%)	0 of 339
Placebo	5 of 336 (1.5%)	102 of 336 (30.4%)	1 of 336

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 www.novctrd.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
Asthma Control
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
Asthma

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.

110 sites in 10 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 110 sites in 10 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 110 sites in United States, Argentina, Germany, Slovakia, Turkey (Türkiye) and 5 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 12 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 at Week 12 (time frame: 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 NCT03215758.

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.