Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, 6-week, Crossover Study to Examine the Effects of Tiotropium (Spiriva® HandiHaler®, 18 µg Once Daily) on Dynamic Hyperinflation and Physical Exercise Capacity in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.


Options:
A: Arm Label: 18 mcg tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): 18 mcg tiotropium | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Pedometer-based activity promotion; Type: EXPERIMENTAL; Interventions: Behavioral: Pedometer-based activity promotion, Other: Pulmonary rehabilitation (Standard care) | Arm Label: Short patient education and exercise; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Short patient education and exercise, Other: Pulmonary rehabilitation (Standard care) | Intervention Type: BEHAVIORAL; Name: Pedometer-based activity promotion; Assigned to Arm(s): Pedometer-based activity promotion | Intervention Type: BEHAVIORAL; Name: Short patient education and exercise; Assigned to Arm(s): Short patient education and exercise | Intervention Type: OTHER; Name: Pulmonary rehabilitation (Standard care); Assigned to Arm(s): Pedometer-based activity promotion, Short patient education and exercise
C: Arm Label: Tool + Self-management Support Program; Type: EXPERIMENTAL; Interventions: Device: Tool, Behavioral: Self-management Support Program | Arm Label: Self- management Support Program; Type: EXPERIMENTAL; Interventions: Behavioral: Self-management Support Program | Arm Label: Care as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Tool; Assigned to Arm(s): Tool + Self-management Support Program | Intervention Type: BEHAVIORAL; Name: Self-management Support Program; Assigned to Arm(s): Self- management Support Program, Tool + Self-management Support Program
D: Arm Label: Pulmonary Rehabilitation Group; Type: EXPERIMENTAL; Interventions: Other: Pulmonary Rehabilitation | Arm Label: Standard Care Group; Type: ACTIVE_COMPARATOR; Interventions: Other: Daily medication | Intervention Type: OTHER; Name: Pulmonary Rehabilitation; Assigned to Arm(s): Pulmonary Rehabilitation Group | Intervention Type: OTHER; Name: Daily medication; Assigned to Arm(s): Standard Care Group

Answer: A