Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD
NCT number | NCT00288548 |
Other study ID # | MeFCo2 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | February 7, 2006 |
Last updated | February 17, 2006 |
Start date | February 2006 |
We want to study the effect of the combination of metoprolol (a beta-blocker) with formoterol (a beta-agonist) on long function in patients with Chronic Obstructive Pulmonary Disease (COPD). There are more and more clues that a beta-blocker, when well chosen and in the right dosage, won't harm the long function in patients with COPD. Since a beta-blocker can be a valuable addition to treating patients with heart problems we would like to see if this category of medication can be available for COPD patients in the future.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: - male/female aged between 40-70 inclusive - COPD defined by GOLD criteria - FEV1 greater or equal to 60% of predicted without medication - baseline FEV1 greater or equal than 1.2L - 10 or more pack years - no hard contraindications for use of beta blockers - being able to perform technically acceptable pulmonary function tests - signed informed consent - systolic blood pressure equal to 130 or greater Exclusion Criteria: - instable COPD during the month before visit 1 - usage of corticosteroids during the month before visit 1 - significant pulmonary diseases other than COPD - a history of cancer within the last 5 years (basal cell carcinoma or cutaneous squamous cell carcinoma allowed) - a recent history of myocardial infarction - use of an investigational drug within one month or six half lives (which ever is greater) of visit 1 - contra-indications for the use of ipratropium-bromide |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Martini Hospital | Groningen |
Lead Sponsor | Collaborator |
---|---|
Martini Hospital Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in airway reactivity after treatment with metoprolol compared to placebo. | |||
Secondary | Effect of formoterol on airway reactivity comparing metoprolol with placebo. | |||
Secondary | Borg-scores during provocation test | |||
Secondary | Peak-flow measurements | |||
Secondary | CCQ-scores | |||
Secondary | Exacerbation rate and rescue medication use |
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