Tiotropium In Exercise

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Pfizer
• Treatments: Tiotropium Bromide

Criteria

Inclusion criteria

1. All patients must sign an informed consent

2. Diagnosis of COPD with specific spirometric criteria (determined at study visits)

3. Age >= 40 years

4. Medical Research Council Dyspnoea score >= 2

5. Current or ex-smoker with a >= 10 pack-year smoking history

6. Ability to exercise on treadmill

Exclusion criteria

1. Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment

2. Clinical history of asthma

3. Use of supplemental oxygen therapy

4. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)

5. Recent history (<= 12 months) of myocardial infarction

6. Unstable or life-threatening cardiac arrhythmia

7. Malignancy treated with radiation therapy or chemotherapy in the last 5 years

8. Pregnant or nursing women

9. Known hypersensitivity to anticholinergic drugs or any component of the study medications

10. Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1

11. Estimated life expectancy < 2 years

12. Symptomatic prostatic hyperplasia or bladder neck obstruction

13. Known narrow-angle glaucoma

14. Any condition that is contraindicated for exercise

15. Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing

16. Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space