Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma

A Multi-centre, Randomized, Double-blind, Placebo-controlled, Multiple-dose, 4-way Crossover Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Salts (Maleate, Xinafoate, and Acetate) in Patients With Persistent Asthma

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

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.