Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: indacaterol maleate/mometasone furoate; placebo to indacaterol maleate/mometasone furoate; fluticasone proprionate / salmeterol xinafoate
Intervention description: Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.; Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.; Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.
Intervention MeSH terms: Fluticasone; Mometasone Furoate; Salmeterol Xinafoate; Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma, QMF149, fixed combination of indacaterol and mometasone furoate

Summary:

      This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500
      μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent
      asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adult patients aged 18-75 years with persistent asthma

          -  Patients with persistent asthma, diagnosed according to the Global Initiative for
             Asthma guidelines (GINA) and who additionally met the following criteria:

               1. Patients receiving daily treatment with inhaled corticosteroid up to the maximum
                  dose per day indicated in the package leaflet, in a stable regimen for the month
                  prior to Visit 1.

               2. Patients with a forced expiratory volume in 1 second (FEV1) at Visit 1 of ≥ 50%
                  of the predicted normal value. This criterion for FEV1 had to be demonstrated
                  after a washout period of at least 6 hours during which no short acting
                  β2-agonist had been inhaled, and a minimum of 48 hours for a long acting
                  β2-agonist.

               3. Patients who demonstrated an increase of ≥12% and ≥200 mL in FEV1 over their
                  pre-bronchodilator value 30 minutes after inhaling a total of 200 μg of
                  salbutamol (or albuterol) via metered dose inhaler (MDI) (the reversibility
                  test). Reversibility had to be demonstrated after an appropriate washout period
                  of at least 6 hrs prior to the evaluation for a shortacting β2-agonist. The
                  administration of salbutamol (or albuterol) for the reversibility test was to be
                  within 30 minutes after pre-bronchodilator spirometry. Reversibility had to be
                  demonstrated at Visit 1 or between Visits 1 and 2, in order for patients to be
                  included in the trial.

               4. For each patient, the smaller value of the Visit 1 FEV1 or the Visit 2 FEV1
                  pre-dose value had to be at least 85% of the larger value.

          -  Body mass index (BMI) between 18 and 32 kg/m^2 and weight >50 kg.

          -  patients using local contraception

        Exclusion Criteria:

          -  Pregnant or nursing women

          -  Recent use of tobacco or history of smoking > 10 pack years

          -  Patients diagnosed with chronic obstructive pulmonary disease (COPD)

          -  Patients with recent experience of severe asthma attack/exacerbation within 6-months
             of study start

          -  Patients with frequent rescue medication (>8 puffs/day for two consecutive days)

          -  Clinically relevant laboratory abnormality or a clinically significant condition

          -  Active cancer or a history of cancer with less than 5 years disease free survival time

          -  History of long QT syndrome or with long QTc interval prior to dosing

          -  History of hypersensitivity to the study drugs or to drugs with similar chemical
             structures

          -  Use of certain medications

          -  Use of other investigational drugs

          -  A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result

          -  History of immunodeficiency diseases, including a positive human immumodeficiency
             virus (HIV) test result.

          -  History of drug or alcohol abuse or evidence of such abuse

        Other protocol-defined inclusion/exclusion criteria may apply.