Conditions: Chronic Obstructive Pulmonary Disease (COPD) Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 55
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and tolerability of single doses of LAS190792 administered by inhalation to patients with mild persistent asthma and moderate to severe chronic obstructive pulmonary disease (COPD) and also to assess the ability of LAS190792 to produce bronchodilation (opening of the airways).

Detailed description:
This study is an integrated Phase I protocol divided into 2 parts.

Part one: a single ascending dose study (6 LAS190792 dose levels) in 16 male subjects with mild asthma. LAS190792 will be administered (by the Genuair® inhaler) under supervision at the study centre, according to the randomisation scheme. One dose level will be administered per week with 2 to 3 weeks between each dose level for the safety and pharmacokinetic data review.

Part two: A 5-way , crossover, single dose study (of LAS190792 \[two doses\], indacaterol, tiotropium and placebo) in 40 male and non-childbearing potential women subjects with moderate to severe COPD. Each treatment period will be separated by a washout period of at least 7 to 14 days. The aim is to ensure at least 30 subjects complete Part 2 of the study. The primary comparison for bronchodilation will be between LAS190792 doses and placebo. Other treatment comparisons (indacaterol or tiotropium vs placebo and LAS190792 vs indacaterol or tiotropium) will be considered additional.

Arms:
arm 1: Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) arm 2: Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) arm 3: Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) arm 4: Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) arm 5: Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) arm 6: Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) arm 7: Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) arm 8: Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) arm 9: Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) arm 10: Single dose, oral inhalation by HandiHaler® single-dose DPI arm 11: Single dose, oral inhalation by Breezhaler® single-dose DPI arm 12: Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)

Interventions: intervention 1: LAS190792 Dose 1 intervention 2: LAS190792 Dose 2 intervention 3: LAS190792 Dose 3 intervention 4: LAS190792 Dose 4 intervention 5: LAS190792 Dose 5 intervention 6: LAS190792 Dose 6 intervention 7: LAS190792 Dose 1 (Part 2) intervention 8: LAS190792 Dose 2 (Part 2) intervention 9: Tiotropium 18 μg intervention 10: Indacaterol 150 μg intervention 11: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None

Protocol document: