Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Martini Hospital Groningen
• Treatments: Formoterol Fumarate; Metoprolol

Criteria

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