Efficacy and Safety Comparison of Tiotropium Daily + Salmeterol Daily or Twice Daily Versus Tiotropium Daily in Patients With COPD
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.
Timeline
- Start
- 2008-04-15
- Primary completion
- 2009-07-22
- Completion
- 2009-07-22
Outcome
Mixed primary results
registry analysis (superiority test); 7.5 µg /25 µg Tio /Salmeterol (T+S_PE) vs 50 µg Salmeterol MDPI (Salm50DPI); p <0.0001; Difference of adjusted means 0.130 (95% CI 0.102 to 0.158); ANOVA NCT00662792 ↗
registry analysis (non-inferiority test); 7.5 µg /25 µg Tio /Salmeterol (T+S_PE) vs 18µg Tiotropium (Tio18GEL); p = 0.0857; Difference of adjusted means 0.029 (95% CI -0.004 to 0.063); ANOVA NCT00662792 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Salmeterol | Other / unclassified | 50 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 18 ug | Inhaled |
| Subject | Tiotropium/Salmeterol | Unknown | — | Inhaled |