Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Metoprolol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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René Aalbers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Martini Hospital Groningen

Locations

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Martini Hospital

Groningen, Provincie Groningen, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Mirjam Mensing, Drs.

Role: CONTACT

Phone: +31 50 524 7817

Email: [email protected]

Other Identifiers

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MeFCo2

Identifier Type: -

Identifier Source: org_study_id