Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Randomised, Placebo- and Active-controlled, 5 Way, Crossover Trial to Characterise the Pharmacokinetics and Evaluate the Bronchodilator Efficacy and Safety of Once-daily Tiotropium Delivered (Double-blind) From the Respimat Inhaler as Solution for Inhalation (1.25, 2.5, 5 mcg or Placebo) and as Inhalation Powder (18mcg) From the HandiHaler (Open Label) After 4 Week-treatment Periods in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in the body over a period of hours and provides information on potential effects of the medication.


Options:
A: Arm Label: Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Oxygen | Arm Label: No oxygen; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Oxygen; Assigned to Arm(s): Oxygen
B: Arm Label: Cognitive Behavioral Therapy (CBT-I); Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia | Arm Label: CBT-I + COPD-ED; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia, Behavioral: COPD Education | Arm Label: COPD Education (COPD-ED); Type: EXPERIMENTAL; Interventions: Behavioral: COPD Education | Arm Label: Attention Control (AC); Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Attention Control | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy for Insomnia; Assigned to Arm(s): CBT-I + COPD-ED, Cognitive Behavioral Therapy (CBT-I) | Intervention Type: BEHAVIORAL; Name: COPD Education; Assigned to Arm(s): CBT-I + COPD-ED, COPD Education (COPD-ED) | Intervention Type: BEHAVIORAL; Name: Attention Control; Assigned to Arm(s): Attention Control (AC)
C: Arm Label: Tiotropium Respimat 5mcg (Tio R5); Type: OTHER; Interventions: Drug: Tiotropium Inhalation Solution | Arm Label: Tiotropium Respimat 10mcg (Tio R10); Type: OTHER; Interventions: Drug: Tiotropium Inhalation Solution | Arm Label: Placebo; Type: OTHER; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Tiotropium Inhalation Solution; Assigned to Arm(s): Tiotropium Respimat 10mcg (Tio R10), Tiotropium Respimat 5mcg (Tio R5) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Tiotropium low; Type: EXPERIMENTAL; Interventions: Drug: Tiotropium low | Arm Label: Tiotropium medium; Type: EXPERIMENTAL; Interventions: Drug: Tiotropium medium | Arm Label: Tiotropium high; Type: EXPERIMENTAL; Interventions: Drug: Tiotropium high | Arm Label: Tiotropium 18mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium 18mcg | Arm Label: Tiotropium placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Tiotropium placebo | Intervention Type: DRUG; Name: Tiotropium medium; Assigned to Arm(s): Tiotropium medium | Intervention Type: DRUG; Name: Tiotropium low; Assigned to Arm(s): Tiotropium low | Intervention Type: DRUG; Name: Tiotropium high; Assigned to Arm(s): Tiotropium high | Intervention Type: DRUG; Name: Tiotropium 18mcg; Assigned to Arm(s): Tiotropium 18mcg | Intervention Type: DRUG; Name: Tiotropium placebo; Assigned to Arm(s): Tiotropium placebo

Answer: D