EUCTR2006-001009-27-PT
Active, not recruiting
Not Applicable
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Long Term (one year) Efficacy and Safety Study of Tiotropium Inhalation Solution 5µg (2 puffs of 2.5µg) Delivered by the Respimat Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD) - ROSES
Boehringer Ingelheim (UK), Ltd0 sites3,000 target enrollmentAugust 21, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD).
- Sponsor
- Boehringer Ingelheim (UK), Ltd
- Enrollment
- 3000
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female patients aged 40 years or more with a diagnosis of relatively stable, moderate to severe COPD and with a smoking history of at least 10 pack years will be eligible for inclusion in the trial. Patients must have a pre\-bronchodilator FEV1 \= 60% of predicted normal and FEV1 \= 70% of FVC both at screening and on entry to the randomised phase of the trial.
- •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
Exclusion Criteria
- •Principal exclusion criteria are summarised as follows:
- •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 patients’ ability to participate in the study.
- •Recent history (i.e six months or less) of myocardial infarction.
- •Unstable or life\-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
- •Hospitalisation for cardiac failure during the past year.
- •Malignancy requiring resection, radiation or chemotherapy within the last five years.
- •Known narrow angle glaucoma.
- •Patients with a history of asthma, allergic rhinitis or who have a blood eosinophil count \= 600 / mm3\.
- •Patients with a life\-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
- •Known active tuberculosis.
Outcomes
Primary Outcomes
Not specified
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