Conditions: Pulmonary Disease, Chronic Obstructive Chronic Bronchitis Pulmonary Emphysema
Keywords: Pulmonary Disease, Chronic Obstructive Tiotropium Formoterol Bronchodilator Agents Exercise Tolerance Randomized Controlled Trial [Publication Type] COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 33
Healthy volunteers: no

Brief summary:
The primary objective is to comparatively evaluate the isolated effects of a long-acting beta2-adrenergic (formoterol fumarate 12µg b.i.d. via Aeroliser) and combined with a long-acting anti-cholinergic (tiotropium bromide 18µg o.d via Handihaler) on breathlessness, dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic obstructive pulmonary disease. The study hypothesis is that combining long acting bronchodilators with different action mechanisms would promote synergistic effects on clinical outcomes.

Detailed description:
This will be a single center, randomized, double-blind study consisting of two 2-week treatment periods separated by a 5-7 days washout phase without long-acting bronchodilators. Eligible patients who complete the one week screening phase will be randomized to one of two treatment sequences: 1) Formoterol --\> Formoterol + Tiotropium or 2) Formoterol + Tiotropium --\> Formoterol. During the treatment periods, patients will be allowed to use a short-acting beta2-adrenergic+short-acting anticholinergic as rescue medication (salbutamol+ipratropium via MDI)

Arms:
arm 1: Formoterol plus Placebo (Tiotropium) arm 2: Formoterol plus Tiotropium

Interventions: intervention 1: Formoterol plus Placebo (Tiotropium) intervention 2: Formoterol plus Tiotropium
Intervention descriptions: intervention 1: Formoterol 12mcg-capsules (2x/d) + Placebo (Tiotropium) (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks. intervention 2: Formoterol 12mcg-capsule (2x/dia) + Tiotropium 18mcg-capsule (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.

Protocol document: