A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Indacaterol acetate/Mometasone furoate; Mometasone furoate; Salmeterol xinafoate/fluticasone propionate
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2216.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: QMF149, Mometasone furoate (MF), asthma

Summary:

      The purpose of the trial is to evaluate the efficacy and safety of two different doses of
      QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses
      (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic
      participants as determined by pulmonary function testing, and effects on asthma control
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with a diagnosis of asthma, for a period of at least 1 year prior to
             Visit 1 (Screening)

          -  Participants who have used medium or high dose inhaled corticosteroids (ICS) or low
             dose of long acting beta-2 agonist (LABA)/ICS combinations for asthma for at least 3
             months and at stable doses for at least 1 month prior to Visit 1

          -  Participants must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (prior to
             double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS

          -  Pre-bronchodilator ≥ 50% Forced expiratory volume in 1 second (FEV1) of < 85 % of the
             predicted normal value for the participants after withholding bronchodilators at both
             Visit 101 and 102, according to American Thoracic Society/European Respiratory Society
             (ATS/ERS) criteria.

          -  Withholding period of bronchodilators prior to spirometry: short acting beta-2 agonist
             (SABA) for ≥ 6 hours and FDC or free combinations of ICS/LABA for ≥ 48 hours, short
             acting anticholinergics (SAMA) for ≥ 8 hours, xanthines >=07 days

          -  A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is
             allowed at Visit 101 and at Visit 102.

        Spacer devices are permitted for reversibility testing only.

        -Participants who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after
        administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101 All
        participants must perform a reversibility test at Visit 101

        If reversibility is not demonstrated at Visit 101:

          -  Reversibility should be repeated once-

          -  Participants may be permitted to enter the study with historical evidence of
             reversibility that was performed according to ATS/ERS guidelines within 2 years prior
             to Visit 1

          -  Alternatively, participants may be permitted to enter the study with a historical
             positive bronchoprovocation test that was performed within 2 years prior to Visit 1.

        Exclusion Criteria:

          -  Participants who have smoked or inhaled tobacco products within the 6 month period
             prior to Visit 1, or who have a smoking history of greater than 10 pack years. This
             includes use of nicotine inhalers such as e-cigarettes at the time of Visit 1

          -  Participants who have had an asthma attack/exacerbation requiring systemic steroids or
             hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening)

          -  Participants who have ever required intubation for a severe asthma
             attack/exacerbation.

          -  Participants who have a clinical condition which is likely to be worsened by ICS
             administration (e.g. glaucoma, cataract and fragility fractures) who are according to
             investigator's medical judgment at risk participating in the study).

          -  Participants who have had a respiratory tract infection or asthma worsening as
             determined by the investigator within 4 weeks prior to Visit 1 (Screening) or between
             Visit 1 and Visit 102. Participants may be re-screened 4 weeks after recovery from
             their respiratory tract infection or asthma worsening.

          -  Participants with a history of chronic lung diseases other than asthma, including (but
             not limited to) Chronic Obstructive Pulmonary Disease (COPD), sarcoidosis,
             interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and
             active tuberculosis.

          -  Participants with severe narcolepsy and/or insomnia.

          -  Participants who have a clinically significant electrocardiogram (ECG) abnormality at
             Visit 101 (Start of Run- In epoch) and at any time between Visit 101 and Visit 102
             (including unscheduled ECG). ECG evidence of myocardial infarction at Visit 101 (via
             central reader) should be clinically assessed by the investigator with
             supportivedocumentation

          -  Participants with a history of hypersensitivity to lactose, any of the study drugs or
             to similar drugs within the class including untoward reactions to sympathomimetic
             amines or inhaled medication or any component thereof

          -  Participants who have not achieved an acceptable spirometry results at Visit 101 in
             accordance with ATS/ERS criteria for acceptability and repeatability (rescreening
             allowed only once).

        Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify
        due to ATS/ERS criteria. If the participant fails the repeat assessment, the participant
        may be rescreened once

          -  Participants on Maintenance Immunotherapy (desensitization) for allergies or less than
             3 months prior to Visit 101 or participants on Maintenance Immunotherapy for more than
             3 months prior to Visit 101 but expected to change throughout the course of the study.

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using highly effective methods of contraception
             during dosing of study treatment and for 30 days after stopping of study treatment.

          -  Long acting muscarinic antagonist (LAMA) use within 3 months prior to Visit 101