Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

February 17, 2006 updated by: Martini Hospital Groningen

Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RM
        • Recruiting
        • Martini Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Difference in airway reactivity after treatment with metoprolol compared to placebo.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martini Hospital Groningen

Investigators

  • Principal Investigator: René Aalbers, MD, PhD, Martini Hospital Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (Estimate)

February 8, 2006

Study Record Updates

Last Update Posted (Estimate)

February 20, 2006

Last Update Submitted That Met QC Criteria

February 17, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MeFCo2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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