Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease (COPD) efficacy safety inhalation long-acting muscarinic receptor antagonist (LAMA)
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 25
Healthy volunteers: no

Brief summary:
Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg) and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator. 25 patients are to participate in the study and all will be recruited in Sweden. Each patient will visit the study doctor 9 times during the study, whereof 5 visits will be overnight visits. All examinations, treatment and the follow-up is free of charge.

Detailed description:

Arms:
arm 1: 1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation arm 2: 1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation arm 3: 1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation arm 4: 1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride) arm 5: 1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)

Interventions: intervention 1: AZD9164 intervention 2: Tiotropium intervention 3: Placebo
Intervention descriptions: intervention 1: Solution for inhalation through nebulization, single dose intervention 2: Dry powder for inhalation, single dose intervention 3: Placebo

Protocol document: