A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: indacaterol; formoterol; placebo to indacaterol; placebo to formoterol; short acting β2-agonist
Intervention description: Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).; Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.; Placebo TWISTHALER® device; Placebo AEROLIZER® device; 100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 392.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: QMF; indacaterol; Twisthaler®

Summary:

      This study will evaluate the dose response relationship among four doses of indacaterol as
      well as placebo delivered via the TWISTHALER® device.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female adult and adolescent patients aged 12-75 years inclusive (or ≥18-75
             years depending upon regulatory and/or Institutional Review Board (IRB)/Independent
             Ethics Committee (IEC)/Research Ethics Board (REB) approval), who have signed an
             Informed Consent Form prior to initiation of any study-related procedure, including
             any adjustments to asthma medication prior to Visit 1. Patients below the legal age of
             consent are required to have the Informed Consent Form signed by the patient's parent
             / guardian.

          2. Patients with asthma, diagnosed according to Global Initiative for Asthma (GINA)
             guidelines (National Institute of Health, National Heart, Lung and Blood Institute,
             2006) and who additionally meet 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 one second (FEV1) at Visit 1 of ≥50%
                  of the predicted normal value for the patient. This criterion for FEV1 will have
                  to be demonstrated after a washout period of at least 6 hours during which no
                  short acting β2-agonist has been inhaled, and a minimum of 48 hours for a long
                  acting β2-agonist.

               3. Patients who demonstrate an increase of ≥12% and ≥200 mL in FEV1 over their
                  pre-bronchodilator value within 30 minutes after inhaling a total of 200 µg/180
                  µg of salbutamol/albuterol Metered Dose Inhaler (MDI) (or equivalent dose of Dry
                  Powder Inhaler [DPI]) (the reversibility test). Reversibility will have to be
                  demonstrated after an appropriate washout period of at least 6 hrs prior to the
                  evaluation for a short-acting β2-agonist. The administration of
                  salbutamol/albuterol for the reversibility test is to be within 30 minutes after
                  pre bronchodilator spirometry. Reversibility has to be demonstrated at Visit 1 or
                  between Visits 1 and 2, in order for patients to be included in the trial.

        Exclusion Criteria:

          -  Pregnant women, nursing mothers, or females of childbearing potential, regardless of
             whether or not sexually active, if they are not using a reliable form of
             contraception.

          -  Patients with Chronic Obstructive Pulmonary Disease (COPD), or current smokers, or
             patients who have used tobacco products within the 6 month period prior to Visit 1, or
             who have a smoking history of greater than 10 pack years.

          -  Patients:

               1. who's asthma is likely to deteriorate during the study (including seasonal
                  allergy),

               2. hospitalized for an acute asthma attack/asthma exacerbation within 6 months prior
                  to Visit 1,

               3. who have had an emergency room visit for an asthma attack/asthma exacerbation
                  within 6 weeks prior to Visit 1

               4. who have had a respiratory tract infection or emergency room treatment for an
                  asthma attack/asthma exacerbation within 4 weeks prior to Visit 1

               5. Patients who require the use of ≥8 inhalations per day of short acting B2-agonist
                  (100 µg/ 90 µg salbutamol/albuterol MDI or equivalent dose of DPI) on any 2
                  consecutive days from Screening to Randomization.

        Other protocol-defined inclusion/exclusion criteria may apply