Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
Condition: Asthma
MeSH terms: Asthma
Intervention: Indacaterol maleate; Indacaterol acetate; Placebo
Intervention description: 150 μg via Concept1 device; 150 μg via Concept1 device; Capsule containing no active ingredients delivered via Concept1 device
Intervention MeSH terms: 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: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: asthma, asthma attack, difficulty breathing, bronchial diseases, lung, lung diseases, inhaled drugs, bronchodilator, inhaled corticosteriod

Summary:

      This study is a randomized, double-blind, placebo-controlled, three-period cross-over study
      in approximately 54 subjects with asthma.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male and female patients aged ≥ 18 and above

          -  Patients with a documented physician diagnosis of asthma for a period of at least 1
             year prior to screening and who additionally meet the following criteria:

        Patients receiving daily treatment with an inhaled corticosteroid up to the maximum dose
        per day (as indicated in the package leaflet), on a stable regimen for at least 4 weeks
        prior to screening.

          -  Pre-bronchodilator FEV1 ≥ 50 % and ≤ 90% of the predicted normal value for the patient
             during screening.

          -  Patients who demonstrate an increase in FEV1 of ≥ 12% and ≥ 200 mL after
             administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at
             screening.

          -  Subjects must weigh at least 50 kg at screening to participate in the study, and must
             have a body mass index (BMI) within the range of 18 to 40 kg/m2.

        Key Exclusion Criteria:

        -Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to
        any of the following inhaled drugs, drugs of a similar class, or any component thereof:
        Sympathomimetic amines / adrenoceptor agonist agents Lactose or any of the other excipients
        of the study drug (including patients with history of galactose intolerance, Lapp lactase
        deficiency or glucose-galactose malabsorption)

          -  Patients who have had an asthma attack/exacerbation requiring systemic steroids or
             hospitalization or emergency room visit within 6 weeks of screening.

          -  Patients who have had a respiratory tract infection or asthma worsening within 4 weeks
             prior to screening.

          -  Patients with a history of chronic lung diseases other than asthma

          -  Patients who have a decline in PEF from the reference PEF (taken at screening) of ≥30%
             for 5 of 6 consecutive scheduled PEF readings (readings taken at morning and evening)
             during at least 3 days of screening epoch prior to randomization.

          -  Patients who require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours
             (over two consecutive days) during screening prior to randomization.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive hCG laboratory test.

          -  Patients with Type I diabetes or uncontrolled Type II diabetes (HbA1c > 9%) at
             screening.

          -  Current smokers (urine cotinine > than the laboratory's lowest level of quantification
             (LoQ of 500 ng/mL or lower)) and patients who have smoked or inhaled tobacco products
             within the 6 month period prior to screening, or who have a smoking history of greater
             than 10 pack years (Note: 1 pack is equivalent to 20 cigarettes. 10 pack years = 1
             pack /day x 10 yrs., or ½ pack/day x 20 yrs.).