Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

Phase 4

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT00288548
• Lead Sponsor: Martini Hospital Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-02
• Study Start: 2006-02
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-08
• Last Update Submitted: 2006-02-17
• Last Update Posted: 2006-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in airway reactivity after treatment with metoprolol compared to placebo.

Secondary Outcome Measures

Name	Time	Method
Effect of formoterol on airway reactivity comparing metoprolol with placebo.
Borg-scores during provocation test
Peak-flow measurements
CCQ-scores
Exacerbation rate and rescue medication use

Trial Locations

Locations (1)

Martini Hospital; 🇳🇱 Groningen, Netherlands