Main Study: To evaluate and to compare the lung function response to the free combinations of tiotropium 18 μg (QD) + salmeterol 50 μg (QD or BID), salmeterol 50 μg BID and tiotropium 18 μg QD at the end of 6-week treatment periods in patients with COPD. Sub-Study: Was performed in subset of patients participating in the Main Study to assess the effect of the four randomised treatments on dynamic hyperinflation. Extension Study: To establish whether the FEV1 time profile following combination bronchodilator therapy of tiotropium plus salmeterol is affected by the pharmaceutical formulation of salmeterol, i.e. the MDI or the Diskus®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
97
administered via HandiHaler®
administered via metered dose inhaler (MDI)
Area under the curve of forced expiratory volume in one second (FEV1 AUC0-24h)
Time frame: up to 12 hours after morning and evening dose
FEV1 AUC0-12h
Time frame: up to 12 hours after morning and evening dose
FEV1 AUC12-24h
Time frame: after 6 weeks of each treatment
AUC of forced vital capacity (FVC AUC0-12h)
Time frame: after 6 weeks of each treatment
FVC AUC0-24h
Time frame: after 6 weeks of each treatment
FVC AUC12-24h
Time frame: after 6 weeks of each treatment
Peak FEV1
Time frame: after 6 weeks of each treatment
Trough FEV1
Trough FEV1 was defined as the pre-dose FEV1 measured just prior to the last administration of the morning dose of randomised treatment.
Time frame: after 6 weeks of each treatment
Peak FVC
Time frame: after 6 weeks of each treatment
Trough FVC
Trough FVC was defined as the pre-dose FVC measured just prior to the last administration of the morning dose of randomised treatment
Time frame: after 6 weeks of each treatment
Individual FEV measurements at each time point
Time frame: up to 6 weeks
Individual FVC measurements at each time point
Time frame: up to 6 weeks
Peak expiratory flow rate (PEFR) measured twice daily
Time frame: weeks 4 to 6 of each treatment period
Number of inhalations of rescue salbutamol therapy used per day
Time frame: weeks 4 to 6 of each treatment period
Change in focal score of the Mahler Transition Dyspnea Index (TDI)
The TDI focal score is the sum of the three components of the TDI: Functional Impairment, Magnitude of Task and Magnitude of Effort
Time frame: after 6 weeks of each treatment
Number of patients with adverse events
Time frame: up to 33 weeks
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