Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma
Condition: Mild Asthma
MeSH terms: Asthma
Intervention: QMF149 150/80 μg; MF 200 μg
Intervention description: QMF149 150/80 μg o.d via Concept1; MF 200 μg o.d. via Twisthaler®
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 802.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Phase III, blinded, QMF149, Mometasone furoate (MF), mild asthma, Adolescent, adult

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.
    

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.