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: Indacaterol 300 μg plus placebo to formoterol; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to formoterol | Arm Label: Indacaterol 600 μg plus placebo to formoterol; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to formoterol | Arm Label: Formoterol 12 μg plus placebo to indacaterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol, Drug: Placebo to indacaterol | Arm Label: Placebo to indacaterol plus placebo to formoterol; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to indacaterol, Drug: Placebo to formoterol | Intervention Type: DRUG; Name: Indacaterol; Assigned to Arm(s): Indacaterol 300 μg plus placebo to formoterol, Indacaterol 600 μg plus placebo to formoterol | Intervention Type: DRUG; Name: Formoterol; Assigned to Arm(s): Formoterol 12 μg plus placebo to indacaterol | Intervention Type: DRUG; Name: Placebo to indacaterol; Assigned to Arm(s): Formoterol 12 μg plus placebo to indacaterol, Placebo to indacaterol plus placebo to formoterol | Intervention Type: DRUG; Name: Placebo to formoterol; Assigned to Arm(s): Indacaterol 300 μg plus placebo to formoterol, Indacaterol 600 μg plus placebo to formoterol, Placebo to indacaterol plus placebo to formoterol
B: Arm Label: Arformoterol 15 mcg twice daily; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arformoterol Tartrate Inhalation Solution, Drug: Placebo | Arm Label: Tiotropium 18 mcg once daily; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium, Drug: Placebo | Arm Label: Arformoterol /Tiotropium; Type: EXPERIMENTAL; Interventions: Drug: Arformoterol and Tiotropium | Intervention Type: DRUG; Name: Arformoterol Tartrate Inhalation Solution; Assigned to Arm(s): Arformoterol 15 mcg twice daily | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium 18 mcg once daily | Intervention Type: DRUG; Name: Arformoterol and Tiotropium; Assigned to Arm(s): Arformoterol /Tiotropium | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Arformoterol 15 mcg twice daily, Tiotropium 18 mcg once daily
C: 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
D: Arm Label: Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Tiotropium, Drug: Placebo | Arm Label: Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Tiotropium | Arm Label: Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo | Arm Label: Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Tiotropium, Drug: Placebo | Intervention Type: DRUG; Name: Indacaterol; Assigned to Arm(s): Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg, Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium, Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo, Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg, Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium, Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg, Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo, Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg

Answer: C