Conditions: Asthma
Keywords: Abediterol Dry powder inhaler Pressured metered-dose inhaler Pharmacokinetic Pharmacodynamic Safety
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the pharmacodynamics of single doses of abediterol given by 2 different devices in participants with asthma. Abediterol (AZD0548) is a potential for once daily treatment of asthma and chronic obstructive pulmonary disease (COPD) in fixed dose combination (FDC) with an inhaled corticosteroid (ICS) or a novel anti-inflammatory agent. The aim of the clinical studies is to enable further investigations in participants with asthma and COPD to evaluate and develop abediterol as an effective long acting bronchodilator with an acceptable safety profile compared to other inhaled bronchodilators on the market, for the treatment of asthma and COPD.

Detailed description:
This is a randomised, double-blinded, double-dummy, placebo-controlled, multi-centre, six-way William's design, crossover study to assess the pharmacodynamics, pharmacokinetics, and safety of abediterol single dose, given by dry powder inhaler or pressurised metered-dose inhaler, in patients with asthma, on inhaled corticosteroids. During the screening period, all patients will take their own baseline inhaled corticosteroid for 2 weeks. Patients on long-acting β2-agonist/ inhaled corticosteroids will be switched over to the respective inhaled corticosteroid monocomponent. Patients will be provided salbutamol as rescue medication for use throughout the study. Abediterol is an investigational product in early stages of clinical development, therefore individual participants in the clinical studies may not have a clinical benefit, especially in view of alternative therapies (bronchodilators) being available for the treatment of asthma and COPD.

Arms:
arm 1: Dry powder for inhalation administered via dry powder inhaler 0.156 μg/inhalation; (1 inhalation) arm 2: Dry powder for inhalation, administered via dry powder, inhaler 2.5 μg/inhalation; (1 inhalation). arm 3: Pressurised metered-dose, inhaler 0.025 μg/puff; (2 puffs). arm 4: Pressurised metered-dose, inhaler 0.078 μg/puff; (2 puffs). arm 5: Pressurised metered-dose inhaler 1.25 μg/puff; (2 puffs). arm 6: Pressurised metered-dose inhaler (2 puffs) and Dry powder for inhalation administered via dry powder inhaler (1 inhalation).

Interventions: intervention 1: Abediterol 0.156 μg intervention 2: Abediterol 2.5 μg intervention 3: Abediterol 0.05 μg intervention 4: Abediterol 0.156 μg intervention 5: Abediterol 2.5 μg intervention 6: Placebo
Intervention descriptions: intervention 1: Dry powder for inhalation intervention 2: Dry powder for inhalation intervention 3: Pressurised metered-dose inhaler intervention 4: Pressurised metered-dose inhaler intervention 5: Pressurised metered-dose inhaler intervention 6: Pressurised metered-dose inhaler and dry powder for inhalation.

Protocol document: