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Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00288548
Recruitment Status : Unknown
Verified February 2006 by Martini Hospital Groningen.
Recruitment status was:  Recruiting
First Posted : February 8, 2006
Last Update Posted : February 20, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Metoprolol Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD
Study Start Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Primary Outcome Measures :
  1. Difference in airway reactivity after treatment with metoprolol compared to placebo.

Secondary Outcome Measures :
  1. Effect of formoterol on airway reactivity comparing metoprolol with placebo.
  2. Borg-scores during provocation test
  3. Peak-flow measurements
  4. CCQ-scores
  5. Exacerbation rate and rescue medication use

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00288548

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Contact: Mirjam Mensing, Drs. +31 50 524 7817

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Martini Hospital Recruiting
Groningen, Netherlands, 9700 RM
Sponsors and Collaborators
Martini Hospital Groningen
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Principal Investigator: René Aalbers, MD, PhD Martini Hospital Groningen
Layout table for additonal information Identifier: NCT00288548    
Other Study ID Numbers: MeFCo2
First Posted: February 8, 2006    Key Record Dates
Last Update Posted: February 20, 2006
Last Verified: February 2006
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action