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New asthma inhaler shows promise in large trial

NCT ID NCT02892344

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new inhaler called QMF149, which combines two drugs (indacaterol and mometasone), against a standard steroid inhaler (mometasone alone) in 802 adults and teens with mild asthma. The goal was to see if the combination improved lung function and symptom control over 12 weeks. Results showed that QMF149 helped patients breathe better and control their asthma more effectively than the standard treatment.

What this could mean

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

Active substance
QMF149 (indacaterol acetate and mometasone furoate)
What this could lead to
If successful, this could offer a more effective once-daily inhaler for people with mild asthma, improving lung function and symptom control.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all asthma patients. The improvement over existing treatment may be modest, and long-term safety data are limited.

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

802 people

The number who actually took part.

Started

Jan 2017

Finished

Nov 2018

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 to 75 years

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: * Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit * Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visit * Adult patients who are symptomatic at screening despite treatment with existing therapy. Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (inadequately controlled). * Adolescent patients : * If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 . * If taking ICS (low dose)/ LABA, and have ACQ-7 score ≥1 and \<1.5 at Visit 101: they must have ACQ-7 score≥1.5 at Visit 102 ( prior to randomization). * Pre-bronchodilator FEV1≥ 60 % and \< 90 % of the predicted normal value for the patient after withholding bronchodilators at both Visits 101 and 102 * Patients who demonstrate an increase in FEV1 of 12% and ≥ 200 mL within 30 minutes after administration of 400 microgram salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101. Exclusion Criteria: * Patients who have smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year. * Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization (\> 24 hours) or emergency room visit (≤ 24 hours) as follows: * For adults: within 6 weeks of Screening Visit. If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation * For adolescents: Severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR hospitalization (\> 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR emergency room visit (≤ 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids within the last 6 months. * Patients who ever required intubation for a severe asthma attack/exacerbation * Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigator's medical judgment ) * Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening. * Patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study. * Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis. * Patients with Type I diabetes or uncontrolled Type II diabetes. * Patients with narcolepsy and/or insomnia. * Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study. * Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products. * Patients who use a long acting muscarinic antagonist (LAMA) within 3 months prior to Visit 1.

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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.

Mild asthma

Contacts and locations

Locations

  • Novartis Investigative Site

    Bulgaria, Bulgaria, Bulgaria

  • Novartis Investigative Site

    Stara Zagora, Bulgaria, 6000, Bulgaria

  • Novartis Investigative Site

    Pleven, 5800, Bulgaria

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7500692, Chile

  • Novartis Investigative Site

    Santiago, 8380453, Chile

  • Novartis Investigative Site

    Santiago, Chile

  • Novartis Investigative Site

    Viña del Mar, 2520594, Chile

  • Novartis Investigative Site

    Medellín, Antioquia, 0050010, Colombia

  • Novartis Investigative Site

    Bucaramanga, Colombia, Colombia

  • Novartis Investigative Site

    Medellín, Colombia, Colombia

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110911, Colombia

  • Novartis Investigative Site

    Bogotá, Colombia

  • Novartis Investigative Site

    Tartu, Estonia, 51014, Estonia

  • Novartis Investigative Site

    Kohtla-Järve, 30322, Estonia

  • Novartis Investigative Site

    Tallinn, 13419, Estonia

  • Novartis Investigative Site

    Tartu, 51014, Estonia

  • Novartis Investigative Site

    Bochum, Germany, 44791, Germany

  • Novartis Investigative Site

    Marburg, Germany, D-35037, Germany

  • Novartis Investigative Site

    Bad Wörishofen, 86825, Germany

  • Novartis Investigative Site

    Berlin, 10119, Germany

  • Novartis Investigative Site

    Darmstadt, 64283, Germany

  • Novartis Investigative Site

    Frankfurt, 60596, Germany

  • Novartis Investigative Site

    Gauting, 82131, Germany

  • Novartis Investigative Site

    Hamburg, 20354, Germany

  • Novartis Investigative Site

    Hanover, 30173, Germany

  • Novartis Investigative Site

    Landsberg, 86899, Germany

  • Novartis Investigative Site

    Leipzig, 04207, Germany

  • Novartis Investigative Site

    Lübeck, 23552, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Szarvas, Hungary, 5540, Hungary

  • Novartis Investigative Site

    Szeged, Hungary, 6722, Hungary

  • Novartis Investigative Site

    Győr, HUN, 9024, Hungary

  • Novartis Investigative Site

    Százhalombatta, HUN, 2440, Hungary

  • Novartis Investigative Site

    Törökbálint, Pest County, 2045, Hungary

  • Novartis Investigative Site

    Cegléd, 2700, Hungary

  • Novartis Investigative Site

    Gödöllő, 2100, Hungary

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 060, India

  • Novartis Investigative Site

    Vadodara, Gujarat, 390022, India

  • Novartis Investigative Site

    Bangalore, Karnataka, 560099, India

  • Novartis Investigative Site

    Hubli, Karnataka, 580022, India

  • Novartis Investigative Site

    Mysore, Karnataka, 570001, India

  • Novartis Investigative Site

    Cherthala, Kerala, 688524, India

  • Novartis Investigative Site

    Mumbai, Maharashtra, 401107, India

  • Novartis Investigative Site

    Nagpur, Maharashtra, India

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334003, India

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641 045, India

  • Novartis Investigative Site

    Hyderabad, Telangana, 500018, India

  • Novartis Investigative Site

    Varanasi, Uttar Pradesh, 221005, India

  • Novartis Investigative Site

    Cassano delle Murge, BA, 70020, Italy

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Genova, Italy, 16147, Italy

  • Novartis Investigative Site

    Fiumicino, RM, 00054, Italy

  • Novartis Investigative Site

    Roma, 00161, Italy

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 103 0027, Japan

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 103-0027, Japan

  • Novartis Investigative Site

    Setagaya-ku, Tokyo, 157006, Japan

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 162-0053, Japan

  • Novartis Investigative Site

    Toshima-ku, Tokyo, 171-0014, Japan

  • Novartis Investigative Site

    Jūrmala, LVA, LV-2015, Latvia

  • Novartis Investigative Site

    Riga, LV, 1011, Latvia

  • Novartis Investigative Site

    Daugavpils, LV-5417, Latvia

  • Novartis Investigative Site

    Riga, LV 1002, Latvia

  • Novartis Investigative Site

    Riga, LV-1001, Latvia

  • Novartis Investigative Site

    Riga, LV-1004, Latvia

  • Novartis Investigative Site

    Vilnius, 8109, Lithuania

  • Novartis Investigative Site

    Vilnius, LT-08661, Lithuania

  • Novartis Investigative Site

    Alor Star, Kedah, 05460, Malaysia

  • Novartis Investigative Site

    Taiping, Perak, 34000, Malaysia

  • Novartis Investigative Site

    Kuala Terengganu, Terengganu, 20400, Malaysia

  • Novartis Investigative Site

    Putrajaya, 62250, Malaysia

  • Novartis Investigative Site

    Santiago de Surco, Lima region, 33, Peru

  • Novartis Investigative Site

    Cusco, 84, Peru

  • Novartis Investigative Site

    Lima, 10, Peru

  • Novartis Investigative Site

    Lima, 14, Peru

  • Novartis Investigative Site

    Piura, 2000, Peru

  • Novartis Investigative Site

    Iloilo City, Iloilo, 5000, Philippines

  • Novartis Investigative Site

    Manila, 1008, Philippines

  • Novartis Investigative Site

    Quezon City, 1100, Philippines

  • Novartis Investigative Site

    Biaystok, Poland, 15-430, Poland

  • Novartis Investigative Site

    Bialystok, 15-044, Poland

  • Novartis Investigative Site

    Grudziądz, 86-300, Poland

  • Novartis Investigative Site

    Katowice, 40 085, Poland

  • Novartis Investigative Site

    Moscow, 115478, Russia

  • Novartis Investigative Site

    Rostov-on-Don, 344011, Russia

  • Novartis Investigative Site

    Saint Petersburg, 191015, Russia

  • Novartis Investigative Site

    Saint Petersburg, 194044, Russia

  • Novartis Investigative Site

    Saint Petersburg, 196240, Russia

  • Novartis Investigative Site

    Yekaterinburg, 620028, Russia

  • Novartis Investigative Site

    Bardejov, Slovak Republic, 085 01, Slovakia

  • Novartis Investigative Site

    Bojnice, Slovak Republic, 972 01, Slovakia

  • Novartis Investigative Site

    Humenné, Slovak Republic, 066 01, Slovakia

  • Novartis Investigative Site

    Liptovský Hrádok, Slovak Republic, 033 01, Slovakia

  • Novartis Investigative Site

    Spišská Nová Ves, Slovak Republic, 052 01, Slovakia

  • Novartis Investigative Site

    Stropkov, Slovak Republic, 09101, Slovakia

  • Novartis Investigative Site

    Čadca, Slovakia, 022 01, Slovakia

  • Novartis Investigative Site

    Prešov, Slovakia, 080 01, Slovakia

  • Novartis Investigative Site

    Zvolen, Slovakia, 960 01, Slovakia

  • Novartis Investigative Site

    Banská Bystrica, SVK, 974 05, Slovakia

  • Novartis Investigative Site

    Poprad, SVK, 058 01, Slovakia

  • Novartis Investigative Site

    Bratislava, 841 04, Slovakia

  • Novartis Investigative Site

    Sabinov, 08301, Slovakia

  • Novartis Investigative Site

    Winnie Mandela, Free State, 8340, South Africa

  • Novartis Investigative Site

    Middelburg, Mpumalanga, 1050, South Africa

  • Novartis Investigative Site

    Belleville, South Africa, 7530, South Africa

  • Novartis Investigative Site

    Cape Town, ZAF, 7570, South Africa

  • Novartis Investigative Site

    Cape Town, 7531, South Africa

  • Novartis Investigative Site

    Panorama, 7550, South Africa

  • Novartis Investigative Site

    Anyang-si, Gyeonggi-do, 14068, 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

    Busan, 612-896, South Korea

  • Novartis Investigative Site

    Seoul, 02841, South Korea

  • Novartis Investigative Site

    Stockholm, 111 57, Sweden

  • Novartis Investigative Site

    Uppsala, 75237, Sweden

  • Novartis Investigative Site

    Linköping, Östergötland County, 587 58, Sweden

  • Novartis Investigative Site

    Bangkok, Thailand, 10400, Thailand

  • Novartis Investigative Site

    Khon Kaen, THA, 40002, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

  • Novartis Investigative Site

    Ho Chi Minh City, VNM, 700000, Vietnam

  • Novartis Investigative Site

    Haiphong, 180000, Vietnam

More trials for these conditions

Other studies related to the condition(s) this trial covers.