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New asthma pill shows promise in large trial

NCT ID NCT03226392

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding a daily pill called QAW039 to standard asthma treatments helps people with uncontrolled asthma breathe better. Over 700 adults and teens took either QAW039 or a placebo for 12 weeks. The main goal was to see if lung function (measured by how much air they can exhale in one second) improved more with QAW039.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
QAW039 (a drug taken once daily by mouth)
What this could lead to
If it works, this could provide a new add-on treatment option for people whose asthma is not well controlled with current medications.
What could go wrong
This is a completed Phase 3 trial, but results may not show a meaningful benefit over placebo. The drug may also have side effects not yet fully understood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

704 people

The number who actually took part.

Started

Oct 2017

Finished

Aug 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • Novartis Investigative Site

    Andalusia, Alabama, 36420, United States

  • Novartis Investigative Site

    Birmingham, Alabama, 35209, United States

  • Novartis Investigative Site

    Tucson, Arizona, 85745, United States

  • Novartis Investigative Site

    Los Angeles, California, 90048, United States

  • Novartis Investigative Site

    Newport Beach, California, 92663, United States

  • Novartis Investigative Site

    Rolling Hills Estates, California, 90274, United States

  • Novartis Investigative Site

    San Diego, California, 92117, United States

  • Novartis Investigative Site

    San Diego, California, 92120, United States

  • Novartis Investigative Site

    San Jose, California, 95117, United States

  • Novartis Investigative Site

    Stockton, California, 95207, United States

  • Novartis Investigative Site

    Colorado Springs, Colorado, 80907, United States

  • Novartis Investigative Site

    Denver, Colorado, 80230, United States

  • Novartis Investigative Site

    Lafayette, Colorado, 80026, United States

  • Novartis Investigative Site

    Miami, Florida, 33176, United States

  • Novartis Investigative Site

    Miami Gardens, Florida, 33169, United States

  • Novartis Investigative Site

    Tallahassee, Florida, 32308, United States

  • Novartis Investigative Site

    Winter Park, Florida, 32789, United States

  • Novartis Investigative Site

    Paducah, Kentucky, 42001, United States

  • Novartis Investigative Site

    Columbia, Maryland, 21044, United States

  • Novartis Investigative Site

    White Marsh, Maryland, 21162, United States

  • Novartis Investigative Site

    North Dartmouth, Massachusetts, 02747-3322, United States

  • Novartis Investigative Site

    Ann Arbor, Michigan, 48106, United States

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55402, United States

  • Novartis Investigative Site

    Rochester, Minnesota, 55905, United States

  • Novartis Investigative Site

    Saint Charles, Missouri, 63301, United States

  • Novartis Investigative Site

    St Louis, Missouri, 63110, United States

  • Novartis Investigative Site

    St Louis, Missouri, 63141, United States

  • Novartis Investigative Site

    Warrensburg, Missouri, 64093, United States

  • Novartis Investigative Site

    Omaha, Nebraska, 68134, United States

  • Novartis Investigative Site

    Brooklyn, New York, 11235, United States

  • Novartis Investigative Site

    Raleigh, North Carolina, 27607, United States

  • Novartis Investigative Site

    Cincinnati, Ohio, 45245, United States

  • Novartis Investigative Site

    Columbus, Ohio, 43215, United States

  • Novartis Investigative Site

    Marion, Ohio, 43302, United States

  • Novartis Investigative Site

    Mayfield Heights, Ohio, 44124, United States

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74136, United States

  • Novartis Investigative Site

    Altoona, Pennsylvania, 16602, United States

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15241, United States

  • Novartis Investigative Site

    Mt. Pleasant, South Carolina, 29464, United States

  • Novartis Investigative Site

    Dallas, Texas, 75231, United States

  • Novartis Investigative Site

    New Braunfels, Texas, 78130, United States

  • Novartis Investigative Site

    San Antonio, Texas, 78205, United States

  • Novartis Investigative Site

    Murray, Utah, 84107, United States

  • Novartis Investigative Site

    Newport News, Virginia, 23606, United States

  • Novartis Investigative Site

    Spokane, Washington, 99204, United States

  • Novartis Investigative Site

    Goiânia, Goiás, 74110-030, Brazil

  • Novartis Investigative Site

    Porto Alegre, Porto Alegre RS, 90610 000, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Novartis Investigative Site

    Blumenau, Santa Catarina, 89030101, Brazil

  • Novartis Investigative Site

    São Bernardo do Campo, São Paulo, 09715 090, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 05437 010, Brazil

  • Novartis Investigative Site

    Sorocaba, São Paulo, Brazil

  • Novartis Investigative Site

    Pleven, 5800, Bulgaria

  • Novartis Investigative Site

    Rousse, 7002, Bulgaria

  • Novartis Investigative Site

    Sofia, 1000, Bulgaria

  • Novartis Investigative Site

    Stara Zagora, 6000, Bulgaria

  • Novartis Investigative Site

    Kingston, Ontario, K7L 2V7, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M6H 3M2, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M9V 4B4, Canada

  • Novartis Investigative Site

    Windsor, Ontario, N8X 5A6, Canada

  • Novartis Investigative Site

    Ibague, Tolima Department, 730006, Colombia

  • Novartis Investigative Site

    Bogota DC, 110221, Colombia

  • Novartis Investigative Site

    Bogotá, 110111, Colombia

  • Novartis Investigative Site

    Bucaramanga, Colombia

  • Novartis Investigative Site

    Berlin, 10367, Germany

  • Novartis Investigative Site

    Erlangen, 91052, Germany

  • Novartis Investigative Site

    Frankfurt, 60389, Germany

  • Novartis Investigative Site

    Halle, 06108, Germany

  • Novartis Investigative Site

    Hamburg, 20354, Germany

  • Novartis Investigative Site

    Hanover, 30167, Germany

  • Novartis Investigative Site

    Leipzig, 04357, Germany

  • Novartis Investigative Site

    Lübeck, 23552, Germany

  • Novartis Investigative Site

    Hajdúnánás, HUN, 4080, Hungary

  • Novartis Investigative Site

    Kapuvár, HUN, 9330, Hungary

  • Novartis Investigative Site

    Püspökladány, HUN, 4150, Hungary

  • Novartis Investigative Site

    Budapest, 1106, Hungary

  • Novartis Investigative Site

    Pécs, 7635, Hungary

  • Novartis Investigative Site

    Siófok, 8600, Hungary

  • Novartis Investigative Site

    Szigetszentmiklós, H-2310, Hungary

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 060, India

  • Novartis Investigative Site

    Vadodara, Gujarat, 390022, India

  • Novartis Investigative Site

    Nashik, Maharashtra, 422007, India

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334 001, India

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641 045, India

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001, India

  • Novartis Investigative Site

    Ashkelon, 78278, Israel

  • Novartis Investigative Site

    Haifa, 3436212, Israel

  • Novartis Investigative Site

    Jerusalem, Israel

  • Novartis Investigative Site

    Rehovot, 76100, Israel

  • Novartis Investigative Site

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Pisa, PI, 56124, Italy

  • Novartis Investigative Site

    Milan, 20157, Italy

  • Novartis Investigative Site

    Lima Cercado, Lima region, 01, Peru

  • Novartis Investigative Site

    San Isidro, Lima region, 27, Peru

  • Novartis Investigative Site

    San Martín de Porres, Lima region, 31, Peru

  • Novartis Investigative Site

    Cusco, 84, Peru

  • Novartis Investigative Site

    Lima, 1, Peru

  • Novartis Investigative Site

    Piura, 2000, Peru

  • Novartis Investigative Site

    San Juan, 00909, Puerto Rico

  • Novartis Investigative Site

    Barnaul, 656024, Russia

  • Novartis Investigative Site

    Chelyabinsk, 454021, Russia

  • Novartis Investigative Site

    Moscow, 109544, Russia

  • Novartis Investigative Site

    Moscow, 115478, Russia

  • Novartis Investigative Site

    N.Novgorod, 603126, Russia

  • Novartis Investigative Site

    Penza, 440067, Russia

  • Novartis Investigative Site

    Perm, 614068, Russia

  • Novartis Investigative Site

    Ryazan, 390039, Russia

  • Novartis Investigative Site

    Saint Petersburg, 191186, Russia

  • Novartis Investigative Site

    Saint Petersburg, 194354, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197022, Russia

  • Novartis Investigative Site

    Stavropol, 355000, Russia

  • Novartis Investigative Site

    Yaroslavl, 150054, Russia

  • Novartis Investigative Site

    Yekaterinburg, 620109, Russia

  • Novartis Investigative Site

    Wŏnju, Gangwon-do, 26427, South Korea

  • Novartis Investigative Site

    Bucheon-si, Gyeonggi-do, 14584, South Korea

  • Novartis Investigative Site

    Hwaseong-si, Gyeonggi-do, 18450, South Korea

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 16499, South Korea

  • Novartis Investigative Site

    Seoul, Korea, 03312, South Korea

  • Novartis Investigative Site

    Seoul, Seocho Gu, 06591, South Korea

  • Novartis Investigative Site

    Daegu, 705703, South Korea

  • Novartis Investigative Site

    Incheon, 21431, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Marbella, Andalusia, 29603, Spain

  • Novartis Investigative Site

    Málaga, Andalusia, 29010, Spain

  • Novartis Investigative Site

    Laredo, Cantabria, 39770, Spain

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Novartis Investigative Site

    Barcelona, Vic, 08500, Spain

  • Novartis Investigative Site

    Barcelona, 08006, Spain

  • Novartis Investigative Site

    Barcelona, 08540, Spain

  • Novartis Investigative Site

    Girona, 17005, Spain

  • Novartis Investigative Site

    Santiago de Compostela, 1506, Spain

  • Novartis Investigative Site

    Zaragoza, 50009, Spain

  • Novartis Investigative Site

    Lund, SE-221 85, Sweden

  • Novartis Investigative Site

    Umeå, 907 40, Sweden

  • Novartis Investigative Site

    Visby, 621 50, Sweden

  • Novartis Investigative Site

    Bab Saadoun, 1007, Tunisia

  • Novartis Investigative Site

    Haiphong, 180000, Vietnam

  • Novartis Investigative Site

    Hanoi, 100000, Vietnam

  • Novartis Investigative Site

    Ho Chi Minh City, 700000, Vietnam

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