Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)
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ClinicalTrials.gov Identifier: NCT00288548
Recruitment Status : Unknown
Verified February 2006 by Martini Hospital Groningen. Recruitment status was: Recruiting
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.
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Ages Eligible for Study:
40 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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