Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 147
Healthy volunteers: no

Brief summary:
The primary objective of this trial is to establish superiority of the once-daily Tiotropium plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in night-time lung function response over the comparator treatments inhaled in their established dose regimens when administered for 6-week periods to patients with chronic obstructive pulmonary disease (COPD). The main secondary objective is to evaluate the safety of the Tiotropium plus Salmeterol Inhalation Powder versus the comparator treatments.

Detailed description:

Arms:
arm 1: 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE)/ 18 µg Tiotropium (Tio18GEL) / 50 µg Salmeterol MDPI (Salm50DPI) / 18 µg Tiotropium (T18GEL) plus 50 µg Salmeterol MDPI (S\_DPI) BID arm 2: 18 µg Tiotropium (Tio18GEL) / 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) / 50 µg Salmeterol MDPI (Salm50DPI) arm 3: 50 µg Salmeterol MDPI (Salm50DPI) / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) / 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 18 µg Tiotropium (Tio18GEL) arm 4: 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 50 µg Salmeterol MDPI (Salm50DPI) / 18 µg Tiotropium (Tio18GEL) / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE)

Interventions: intervention 1: Tiotropium (Tio18GEL) intervention 2: Salmeterol MDPI (Salm50DPI) intervention 3: Tiotropium (T18GEL) + Salmeterol MDPI (S_DPI) intervention 4: Tiotropium/Salmeterol (T+S_PE)
Intervention descriptions: intervention 1: 18 µg Tiotropium (Tio18GEL) inhalation powder intervention 2: 50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID) intervention 3: 18 µg Tiotropium (T18GEL) inhalation powder plus 50 µg Salmeterol MDPI (S\_DPI) twice daily (BID) intervention 4: Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) inhalation powder

Protocol document: