Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease sleeping oxygen saturation sleep quality
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 200
Healthy volunteers: no

Brief summary:
The aim of this study was to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD.

Detailed description:
Patients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD. In a randomized, parallel-group trial involving 200 patients with mild to moderate COPD (resting arterial oxygen tension \>60 mmHg while awake), we compared the effects of 6 months' treatment with the two devices on sleeping SaO2 and sleep quality.

Arms:
arm 1: Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler arm 2: Tiotropium was delivered via the Respimat® Soft Mist Inhaler,

Interventions: intervention 1: tiotropium intervention 2: Handihaler intervention 3: Respimat
Intervention descriptions: intervention 1: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. intervention 2: Inhalation via the HandiHaler once daily intervention 3: Inhalation via the Respimat once daily

Protocol document: