Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomised, Double-blind, Double-dummy, Parallel Group, One-year Study).
Brief Summary: This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week randomised treatment phase. Patients who withdraw prematurely from trial medication will be encouraged to remain in the trial and participate in follow-up telephone contacts until their predicted normal exit date from the trial (i.e. 52 weeks after taking the first dose of randomised treatment). The phone calls will be made at all scheduled visits.

The primary objective of this study is to compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD exacerbations.

The primary endpoint is time to first COPD exacerbation during the 52 week randomised treatment period. A COPD exacerbation will be defined as a complex of respiratory events / symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnoea or chest tightness with at least one symptom lasting at least three days requiring treatment with antibiotics and/or systemic steroids and/or hospitalisation.

The onset of an exacerbation is defined as the onset of the first new or increased reported symptom. The end of the exacerbation should be recorded as defined by the investigator.

Only COPD exacerbations with onset during randomised treatment will be included in the analysis.


Options:
A: Arm Label: Aclidinium 200 μg once-daily; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium bromide | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Aclidinium bromide; Assigned to Arm(s): Aclidinium 200 μg once-daily | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Tiotropium + Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium bromide, Drug: Placebo Salmeterol | Arm Label: Salmeterol + Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Salmeterol, Drug: Placebo Tiotropium | Intervention Type: DRUG; Name: Tiotropium bromide; Assigned to Arm(s): Tiotropium + Placebo | Intervention Type: DRUG; Name: Salmeterol; Assigned to Arm(s): Salmeterol + Placebo | Intervention Type: DRUG; Name: Placebo Salmeterol; Assigned to Arm(s): Tiotropium + Placebo | Intervention Type: DRUG; Name: Placebo Tiotropium; Assigned to Arm(s): Salmeterol + Placebo
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Budesonide/formoterol (Symbicort Turbuhaler) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol (Oxis Turbuhaler) | Intervention Type: DRUG; Name: Budesonide/formoterol (Symbicort Turbuhaler); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Formoterol (Oxis Turbuhaler); Assigned to Arm(s): 2
D: Intervention Type: DRUG; Name: Tiotropium bromide; Assigned to Arm(s): N/A

Answer: B