A randomized, double-blind, placebo-controlled two-year trial to examine the changes in Exercise Endurance and COPD Patients Treated with Tiotropium (Spiriva HandiHaler) 18 µg once daily (EXACTT trial) - EXACTT
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 6.1Level: PTClassification code 10009026
- Registration Number
- EUCTR2006-004610-41-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 538
-Male or female -40 years old or more -with a diagnosis of COPD (pre-bronchodilator FEV1 60% or less then predicted, post bronchodilator FEV1 65% or less then predicted, FEV1/FVC less then 70%) -smoking history 10 or more pack-years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-Patients with significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patient?s ability to participate in the study. -Patients with a history of asthma. -A history of thoracotomy with pulmonary resection. -Patients requiring the use of supplemental oxygen therapy. -Patients with any respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3. These patients may be randomized 6 weeks following recovery from the infection or exacerbation -Patients with a recent history (i.e., 12 months or less) of myocardial infarction. -Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year. -Malignancy for which patient is undergoing radiation therapy or chemotherapy, within the last 5 years. -Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception. -A known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule, or to components in Atrovent or in the provided rescue medication. -Patients who are currently in a pulmonary or cardiac rehabilitation program or who have completed a pulmonary or cardiac rehabilitation program within 13 weeks of Visit 1. -Patients with a history of significant alcohol or drug abuse in the previous year. -Participation in another trial with an investigational drug within 30 days or 6 half lives (whichever is greater) of the start of the study. -Patients with a history of orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing -Patients with prostatic hyperplasia or bladder neck obstruction. Patients with symptomatically controlled prostatic hyperplasia on medications may be included and should continue their medications -Patients with known narrow-angle glaucoma. -Patients with known moderate to severe renal impairment. -Patients with a body mass index < 18 kg/m**2 or > 35 kg/m**2. Patients who experience oxygen desaturation (oxygen saturation <=85%) during the incremental exercise test or during the constant work rate tests at Visit 3 and 3r. -History of life-threatening pulmonary obstruction, interstitial lung disease, cystic fibrosis, pulmonary thromboembolic disease or clinically evident bronchiectasis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method