Tiotropium In Exercise

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive; Exercise

Treatments: Drug: Placebo; Drug: tiotropium 18 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00525512

205.368

2006-004610-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 519 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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519 participants in 2 patient groups, including a placebo group

tiotropium 18mcg

Experimental group

Description:

Oral inhalation once daily of 18mcg tiotropium via handihaler

Treatment:

Drug: tiotropium 18 mcg

Placebo

Placebo Comparator group

Description:

Oral inhalation once daily of placebo matching tiotropium via handihaler

Treatment:

Drug: Placebo