Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Indacaterol maleate 400 μg; Indacaterol acetate 400 μg; Indacaterol xinafoate 400 μg; Placebo to indacaterol
Intervention description: Indacaterol maleate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.; Indacaterol acetate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.; Indacaterol xinafoate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.; Placebo to indacaterol was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler.
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: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: QAB149; asthma; indacaterol salts (acetate, maleate, and xinafoate); orally inhaled indacaterol salts; persistent asthma

Summary:

      This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate,
      xinafoate and acetate) in patients with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-smoker male and female adult patients aged 18-75 years inclusive, who have signed
             an informed consent form prior to initiation of any study-related procedure, including
             any adjustments to asthma medication prior to screening.

          -  Patients with asthma, receiving daily treatment with inhaled corticosteroid.

          -  Patients with a forced expiratory volume in 1 second (FEV1) during screening of ≥ 50%
             of the predicted normal value for the patient.

          -  Body mass index (BMI) must be within the range 18-32 kg/m^2 (inclusive).

          -  Able to communicate well with the investigator and comply with the requirements of the
             study.

        Exclusion criteria:

          -  A urine cotinine level greater than the local laboratory lowest level of
             quantification (LOQ of 500 ng/ml or lower).

          -  Patients who have had a severe asthma attack/exacerbation requiring hospitalization in
             the 6 months prior to screening.

          -  Patients who have had an emergency room visit for an asthma attack/exacerbation within
             6 weeks prior to screening or any time between screening and pre-dose on day 1 of the
             study.

          -  Patients who have had a respiratory tract infection within 4 weeks prior to screening
             or any time between screening and pre-dose on day 1 of the study.

          -  Patients who require the use of ≥ 8 inhalations per day of the short-acting β2-agonist
             salbutamol/albuterol (100 μg/90 μg salbutamol/albuterol metered dose inhaler [MDI] or
             equivalent dose of a dry-powder inhaler [DPI]) on any 2 consecutive days from
             screening to randomization.

          -  Patients diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the
             Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2008).

          -  Participation in any clinical investigation within 4 weeks prior to dosing or longer
             if required by local regulation. Previous participation in a study with either the
             investigational or comparator drugs does not exclude a patient from participation in
             this study.

          -  Significant illness.

          -  History of being immunocompromised, including a positive human immunodeficiency virus
             (HIV) test result (ELISA and Western blot).

          -  A positive hepatitis B surface antigen (HBsAg) or hepatitis C test result.

          -  Patients who are considered vulnerable as per ICH GCP guidelines.

          -  Patients with a history of hypersensitivity to indacaterol or to similar drugs
             including untoward reactions to sympathomimetic amines or inhaled medication or any
             component thereof.

          -  Treatments for asthma and allied conditions:

          -  The following treatments should not be used unless they have been stabilized prior to
             screening: antihistamines, inhaled nasal cromolyn, inhaled nasal corticosteroids, and
             maintenance immunotherapy.

        Other protocol-defined inclusion/exclusion criteria applied to the study.