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Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma | Clinical Trials | Clareo Health

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

A Multi-center, Randomized, 12-week Treatment, Doubleblind Study to Assess the Efficacy and Safety of QMF149 (150/80 Microgram) Compared With MF Twisthaler® (200 Microgram) in Adult and Adolescent Patients With Asthma

NCT02892344•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - 75 years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (123)

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

Key Dates

Start Date

January 16, 2017

Primary Completion Date

November 5, 2018

Completion Date

November 30, 2018

Last Updated

January 13, 2026

Enrollment

802

ACTUAL participants

Conditions

Mild Asthma

Interventions

QMF149 150/80 μg

DRUG

MF 200 μg

DRUG

Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma

NCT04912596

Mild Asthma

View study

RECRUITING

MANI Real-life Perspective Observatory

NCT04796844

AsthmaMild Asthma+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma

MANI Real-life Perspective Observatory

Biomarkers of iNOS Activity in COPD, Asthma, Healthy Control

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