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New asthma pill shows promise in large trial

NCT ID NCT03215758

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a daily pill called QAW039 can help people with uncontrolled asthma breathe better. 675 adults and teens took either the drug or a placebo for 12 weeks, on top of their usual inhalers. The main goal was to see if lung function improved.

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 offer a new add-on treatment option for people whose asthma is not well controlled with current inhalers.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely known. The drug may not improve lung function enough to be approved, and side effects are possible.

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

675 people

The number who actually took part.

Started

Nov 2017

Finished

Jul 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

    Flagstaff, Arizona, 86001, United States

  • Novartis Investigative Site

    Phoenix, Arizona, 85006, United States

  • Novartis Investigative Site

    Huntington Beach, California, 92647, United States

  • Novartis Investigative Site

    Long Beach, California, 90808, United States

  • Novartis Investigative Site

    Los Angeles, California, 90025, United States

  • Novartis Investigative Site

    Mission Viejo, California, 92691, United States

  • Novartis Investigative Site

    Mountain View, California, 94040, United States

  • Novartis Investigative Site

    Orange, California, 92868, United States

  • Novartis Investigative Site

    Roseville, California, 95661, United States

  • Novartis Investigative Site

    Walnut Creek, California, 94598, United States

  • Novartis Investigative Site

    Denver, Colorado, 80206, United States

  • Novartis Investigative Site

    Tamarac, Florida, 33321, United States

  • Novartis Investigative Site

    Winter Park, Florida, 32789, United States

  • Novartis Investigative Site

    Albany, Georgia, 31707, United States

  • Novartis Investigative Site

    Dacula, Georgia, 30019, United States

  • Novartis Investigative Site

    Honolulu, Hawaii, 96814, United States

  • Novartis Investigative Site

    Lihue, Hawaii, 96766, United States

  • Novartis Investigative Site

    Overland Park, Kansas, 66210, United States

  • Novartis Investigative Site

    Louisville, Kentucky, 40215, United States

  • Novartis Investigative Site

    Columbia, Missouri, 65203, United States

  • Novartis Investigative Site

    Rolla, Missouri, 65401, United States

  • Novartis Investigative Site

    Missoula, Montana, 59808, United States

  • Novartis Investigative Site

    Bellevue, Nebraska, 68123, United States

  • Novartis Investigative Site

    La Vista, Nebraska, 68128, United States

  • Novartis Investigative Site

    Skillman, New Jersey, 08558, United States

  • Novartis Investigative Site

    Asheville, North Carolina, 28801, United States

  • Novartis Investigative Site

    Gastonia, North Carolina, 28054, United States

  • Novartis Investigative Site

    High Point, North Carolina, 27262, United States

  • Novartis Investigative Site

    Cincinnati, Ohio, 45231, United States

  • Novartis Investigative Site

    Edmond, Oklahoma, 73034, United States

  • Novartis Investigative Site

    Eugene, Oregon, 97401-4043, United States

  • Novartis Investigative Site

    Medford, Oregon, 97504, United States

  • Novartis Investigative Site

    Portland, Oregon, 97213, United States

  • Novartis Investigative Site

    Portland, Oregon, 97220, United States

  • Novartis Investigative Site

    Rapid City, South Dakota, 57701, United States

  • Novartis Investigative Site

    Boerne, Texas, 78006, United States

  • Novartis Investigative Site

    Dallas, Texas, 75231, United States

  • Novartis Investigative Site

    El Paso, Texas, 79903, United States

  • Novartis Investigative Site

    Fort Worth, Texas, 76109, United States

  • Novartis Investigative Site

    McKinney, Texas, 75069, United States

  • Novartis Investigative Site

    Seattle, Washington, 98122-4379, United States

  • Novartis Investigative Site

    Greenfield, Wisconsin, 53228, United States

  • Novartis Investigative Site

    Berazategui, Buenos Aires, 1888, Argentina

  • Novartis Investigative Site

    CABA, Buenos Aires, C1056ABJ, Argentina

  • Novartis Investigative Site

    CABA, Buenos Aires, C1122AAK, Argentina

  • Novartis Investigative Site

    CABA, Buenos Aires, C1425BEN, Argentina

  • Novartis Investigative Site

    CABA, Buenos Aires, C1426ABP, Argentina

  • Novartis Investigative Site

    Lanus, Buenos Aires, B8000XAV, Argentina

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Novartis Investigative Site

    Santa Rosa, La Pampa Province, 6300, Argentina

  • Novartis Investigative Site

    Buenos Aires, Nueve De Julio, B6500BWQ, Argentina

  • Novartis Investigative Site

    Santa Fe, Rosario, S2000DBS, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000BRH, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000JKR, Argentina

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1012AAR, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1125ABE, Argentina

  • Novartis Investigative Site

    Córdoba, X5003DCE, Argentina

  • Novartis Investigative Site

    Mendoza, 5500, Argentina

  • Novartis Investigative Site

    Mendoza, M5500CBA, Argentina

  • Novartis Investigative Site

    Salta, 4000, Argentina

  • Novartis Investigative Site

    Peine, Lower Saxony, 31224, Germany

  • Novartis Investigative Site

    Cottbus, Saxony, 03050, Germany

  • Novartis Investigative Site

    Aschaffenburg, 63739, Germany

  • Novartis Investigative Site

    Bamberg, 96049, Germany

  • Novartis Investigative Site

    Berlin, 12157, Germany

  • Novartis Investigative Site

    Berlin, 12203, Germany

  • Novartis Investigative Site

    Fürstenwalde, 15517, Germany

  • Novartis Investigative Site

    Gauting, 82131, Germany

  • Novartis Investigative Site

    Leipzig, 04275, Germany

  • Novartis Investigative Site

    Lübeck, 23552, Germany

  • Novartis Investigative Site

    Prien A Chiemsee, 83209, Germany

  • Novartis Investigative Site

    Rüdersdorf, 15562, Germany

  • Novartis Investigative Site

    Schleswig, 24837, Germany

  • Novartis Investigative Site

    Schwerin, 19055, Germany

  • Novartis Investigative Site

    Witten, 58452, Germany

  • Novartis Investigative Site

    Budaörs, HUN, 2040, Hungary

  • Novartis Investigative Site

    Ajka, 8400, Hungary

  • Novartis Investigative Site

    Budapest, 1125, Hungary

  • Novartis Investigative Site

    Debrecen, 4032, Hungary

  • Novartis Investigative Site

    Gödöllő, 2100, Hungary

  • Novartis Investigative Site

    Szeged, 6722, Hungary

  • Novartis Investigative Site

    Culiacán, Sinaloa, 80230, Mexico

  • Novartis Investigative Site

    Río de Janeiro, 06700, Mexico

  • Novartis Investigative Site

    Lipa City, Batangas, 4217, Philippines

  • Novartis Investigative Site

    Quezon City, Manila, 1100, Philippines

  • Novartis Investigative Site

    Iloilo City, 5000, Philippines

  • Novartis Investigative Site

    Manila, 1000, Philippines

  • Novartis Investigative Site

    Riyadh, SAU, 11525, Saudi Arabia

  • Novartis Investigative Site

    Jeddah, 21423, Saudi Arabia

  • Novartis Investigative Site

    Bardejov, Slovak Republic, 085 01, Slovakia

  • Novartis Investigative Site

    Kežmarok, 060 01, Slovakia

  • Novartis Investigative Site

    Michalovce, 071 01, Slovakia

  • Novartis Investigative Site

    Poprad, 058 01, Slovakia

  • Novartis Investigative Site

    Prešov, 080 01, Slovakia

  • Novartis Investigative Site

    Spišská Nová Ves, 052 01, Slovakia

  • Novartis Investigative Site

    Žilina, 01207, Slovakia

  • Novartis Investigative Site

    Tygerberg, Cape Town, 7505, South Africa

  • Novartis Investigative Site

    Cape Town, 7500, South Africa

  • Novartis Investigative Site

    Chatsworth, 4092, South Africa

  • Novartis Investigative Site

    Durban, 4001, South Africa

  • Novartis Investigative Site

    Pretoria, 0183, South Africa

  • Novartis Investigative Site

    Istanbul, TUR, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Adana, 01330, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, 06100, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, 34020, Turkey (Türkiye)

  • Novartis Investigative Site

    Mersin, 33343, Turkey (Türkiye)

  • Novartis Investigative Site

    Talas / Kayseri, 38039, Turkey (Türkiye)

  • Novartis Investigative Site

    Yenisehir/Izmir, 35110, Turkey (Türkiye)

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