Description:

ODM derived from http://clinicaltrials.gov/show/NCT00525512

Link:

http://clinicaltrials.gov/show/NCT00525512

Keywords:
Versions (2) ▾
  1. 12/10/13
  2. 4/14/14
Uploaded on:

April 14, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00525512 Pulmonary Disease, Chronic Obstructive

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 40 Years
All patients must sign an informed consent
Diagnosis of COPD with specific spirometric criteria (determined at study visits)
Age >= 40 years
Medical Research Council Dyspnea Scale >= 2
Current or ex-smoker with a >= 10 pack-year smoking history
Ability to exercise on treadmill
Exclusion Criteria
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
Clinical history of asthma
Use of supplemental oxygen therapy
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)
Recent history (<= 12 months) of myocardial infarction
Unstable or life-threatening cardiac arrhythmia
Malignancy treated with radiation therapy or chemotherapy in the last 5 years
Pregnant or nursing women
Known hypersensitivity to anticholinergic drugs or any component of the study medications
Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
Estimated life expectancy < 2 years
Symptomatic prostatic hyperplasia or bladder neck obstruction
Known narrow-angle glaucoma
Any condition that is contraindicated for exercise
Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space