Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00288548
• Other study ID #: MeFCo2
• Status: Recruiting
• Phase: Phase 4
• First received: February 7, 2006
• Last updated: February 17, 2006
• Start date: February 2006

Study information

• Verified date: February 2006
• Source: Martini Hospital Groningen
• Contact: Mirjam Mensing, Drs.
• Phone: +31 50 524 7817
• Email: M.Mensing[@]MZH.nl
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Metoprolol

Locations

Country	Name	City	State
Netherlands	Martini Hospital	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Martini Hospital Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

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