A randomized, double-blind, placebo-controlled two-year trial to examine the changes in Exercise Endurance and COPD Patients Treated with Tiotropium (Spiriva (R) HandiHaler (R)) 18 µg once daily (EXACTT trial) - EXACTT
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10009033Term: Chronic obstructive pulmonary disease
- Registration Number
- EUCTR2006-004610-41-DE
- Lead Sponsor
- Boehringer Ingelheim Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 460
- Male or female
-40 years old or more
-with a diagnosis of COPD (pre-bronchodilator FEV1 60% or less than predicted, post bronchodilator FEV1 65% or less than predicted, FEV1/FVC less than 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
-history of asthma
-use of supplemental oxygen therapy
-recent history of MI
-history of thoracotomy with pulmonary resection
-chronic use of systemic corticosterids in an unstable daily dose (< 6 weeks) or a daily dose of>10 mg of prednisone or equivalent
-BPH or bladder neck obstruction; narrow angle glaucome; moderate to severe renal impairment; active tuberculosis
-BMI < 18 kg/m2 or >35 kg/m
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily, in patients with COPD compared to placebo.<br><br>;Secondary Objective: Secondary endpoints:<br>-Exercise duration at Visit 11<br>-FEV1 and FVC measurements at each time point<br>-Questionnaires: Modified Borg Scale; Global evaluation; SGRQ<br>-COPD exacerbations<br>-Exercise duration at visits 4-9;Primary end point(s): The difference between treatment groups of the exercise duration Constant Work Rate (CWR) treadmill exercise at 96 weeks
- Secondary Outcome Measures
Name Time Method