Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma

NCT ID: NCT02892344

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 802 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-16
• Study Completion Date: 2018-11-30

Brief Summary

The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d.

delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.

Detailed Description

The primary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. The key secondary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks of treatment.

Conditions

Mild Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

QMF149 150/80 μg

QMF149 150/80 microgram o.d. delivered via Concept1

Group Type: EXPERIMENTAL

QMF149 150/80 μg

Intervention Type: DRUG

QMF149 150/80 μg o.d via Concept1

MF 200 µg

MF 200 microgram o.d. delivered via Twisthaler®

Group Type: ACTIVE_COMPARATOR

MF 200 μg

Intervention Type: DRUG

MF 200 μg o.d. via Twisthaler®

Interventions

QMF149 150/80 μg

QMF149 150/80 μg o.d via Concept1

Intervention Type: DRUG

MF 200 μg

MF 200 μg o.d. via Twisthaler®

Intervention Type: DRUG

Other Intervention Names

Indacaterol acetate/Mometasone furoate; Mometasone furoate

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Bulgaria, Bulgaria, Bulgaria

Novartis Investigative Site

Stara Zagora, Bulgaria, Bulgaria

Novartis Investigative Site

Pleven, , Bulgaria

Novartis Investigative Site

Santiago, Santiago Metropolitan, Chile

Novartis Investigative Site

Santiago, , Chile

Novartis Investigative Site

Santiago, , Chile

Novartis Investigative Site

Viña del Mar, , Chile

Novartis Investigative Site

Medellín, Antioquia, Colombia

Novartis Investigative Site

Bucaramanga, Colombia, Colombia

Novartis Investigative Site

Medellín, Colombia, Colombia

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Novartis Investigative Site

Bogotá, , Colombia

Novartis Investigative Site

Tartu, Estonia, Estonia

Novartis Investigative Site

Kohtla-Järve, , Estonia

Novartis Investigative Site

Tallinn, , Estonia

Novartis Investigative Site

Tartu, , Estonia

Novartis Investigative Site

Bochum, Germany, Germany

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Marburg, Germany, Germany

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Bad Wörishofen, , Germany

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Berlin, , Germany

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Darmstadt, , Germany

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Frankfurt, , Germany

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Gauting, , Germany

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Hamburg, , Germany

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Hanover, , Germany

Novartis Investigative Site

Landsberg, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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Mainz, , Germany

Novartis Investigative Site

Szarvas, Hungary, Hungary

Novartis Investigative Site

Szeged, Hungary, Hungary

Novartis Investigative Site

Győr, HUN, Hungary

Novartis Investigative Site

Százhalombatta, HUN, Hungary

Novartis Investigative Site

Törökbálint, Pest County, Hungary

Novartis Investigative Site

Cegléd, , Hungary

Novartis Investigative Site

Gödöllő, , Hungary

Novartis Investigative Site

Ahmedabad, Gujarat, India

Novartis Investigative Site

Vadodara, Gujarat, India

Novartis Investigative Site

Bangalore, Karnataka, India

Novartis Investigative Site

Hubli, Karnataka, India

Novartis Investigative Site

Mysore, Karnataka, India

Novartis Investigative Site

Cherthala, Kerala, India

Novartis Investigative Site

Mumbai, Maharashtra, India

Novartis Investigative Site

Nagpur, Maharashtra, India

Novartis Investigative Site

Bikaner, Rajasthan, India

Novartis Investigative Site

Coimbatore, Tamil Nadu, India

Novartis Investigative Site

Hyderabad, Telangana, India

Novartis Investigative Site

Varanasi, Uttar Pradesh, India

Novartis Investigative Site

Cassano delle Murge, BA, Italy

Novartis Investigative Site

Florence, FI, Italy

Novartis Investigative Site

Genova, Italy, Italy

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Fiumicino, RM, Italy

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Roma, , Italy

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Novartis Investigative Site

Setagaya-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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Jūrmala, LVA, Latvia

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Riga, LV, Latvia

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Daugavpils, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

Novartis Investigative Site

Vilnius, , Lithuania

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Vilnius, , Lithuania

Novartis Investigative Site

Alor Star, Kedah, Malaysia

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Taiping, Perak, Malaysia

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Kuala Terengganu, Terengganu, Malaysia

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Putrajaya, , Malaysia

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Santiago de Surco, Lima region, Peru

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Cusco, , Peru

Novartis Investigative Site

Lima, , Peru

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Lima, , Peru

Novartis Investigative Site

Piura, , Peru

Novartis Investigative Site

Iloilo City, Iloilo, Philippines

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Manila, , Philippines

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Quezon City, , Philippines

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Biaystok, Poland, Poland

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Bialystok, , Poland

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Grudziądz, , Poland

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Katowice, , Poland

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Moscow, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Yekaterinburg, , Russia

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Bardejov, Slovak Republic, Slovakia

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Bojnice, Slovak Republic, Slovakia

Novartis Investigative Site

Humenné, Slovak Republic, Slovakia

Novartis Investigative Site

Liptovský Hrádok, Slovak Republic, Slovakia

Novartis Investigative Site

Spišská Nová Ves, Slovak Republic, Slovakia

Novartis Investigative Site

Stropkov, Slovak Republic, Slovakia

Novartis Investigative Site

Čadca, Slovakia, Slovakia

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Prešov, Slovakia, Slovakia

Novartis Investigative Site

Zvolen, Slovakia, Slovakia

Novartis Investigative Site

Banská Bystrica, SVK, Slovakia

Novartis Investigative Site

Poprad, SVK, Slovakia

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Bratislava, , Slovakia

Novartis Investigative Site

Sabinov, , Slovakia

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Winnie Mandela, Free State, South Africa

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Middelburg, Mpumalanga, South Africa

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Belleville, South Africa, South Africa

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Cape Town, ZAF, South Africa

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Cape Town, , South Africa

Novartis Investigative Site

Panorama, , South Africa

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Anyang-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Bucheon-si, Gyeonggi-do, South Korea

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Hwaseong-si, Gyeonggi-do, South Korea

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Suwon, Gyeonggi-do, South Korea

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Seoul, Korea, South Korea

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Seoul, Seocho gu, South Korea

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Busan, , South Korea

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Seoul, , South Korea

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Stockholm, , Sweden

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Uppsala, , Sweden

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Linköping, Östergötland County, Sweden

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Bangkok, Thailand, Thailand

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Khon Kaen, THA, Thailand

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Chiang Mai, , Thailand

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Ho Chi Minh City, VNM, Vietnam

Novartis Investigative Site

Haiphong, , Vietnam

Countries

Bulgaria; Chile; Colombia; Estonia; Germany; Hungary; India; Italy; Japan; Latvia; Lithuania; Malaysia; Peru; Philippines; Poland; Russia; Slovakia; South Africa; South Korea; Sweden; Thailand; Vietnam

References

Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

Reference Type: DERIVED

PMID: 36472162 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=730

A Plain Language Trial Summary is available on novartisclinicaltrials.com

https://www.novctrd.com/ctrdweb/ppatientsummary/ppatientsummaries?periodicPatientSummaryId=512

A Pediatric Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

2016-000472-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQVM149B2303

Identifier Type: -

Identifier Source: org_study_id