Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2006 by Martini Hospital Groningen. Recruitment status was Recruiting

First Received on February 7, 2006. Last Updated on February 17, 2006 History of Changes

Sponsor:	Martini Hospital Groningen
Information provided by:	Martini Hospital Groningen
ClinicalTrials.gov Identifier:	NCT00288548

Purpose

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	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Metoprolol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formoterol fumarate Metoprolol Metoprolol Tartrate Arformoterol Formoterol Metoprolol succinate Metoprolol fumarate Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Martini Hospital Groningen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	45
Study Start Date:	February 2006

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288548

Contacts

Contact: Mirjam Mensing, Drs.

+31 50 524 7817

M.Mensing@MZH.nl

Locations

Netherlands
Martini Hospital	Recruiting
Groningen, Netherlands, 9700 RM

Sponsors and Collaborators

Martini Hospital Groningen

Investigators

Principal Investigator:

René Aalbers, MD, PhD

Martini Hospital Groningen

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00288548 History of Changes
Other Study ID Numbers:	MeFCo2
Study First Received:	February 7, 2006
Last Updated:	February 17, 2006
Health Authority:	Netherlands: Independent Ethics Committee

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Metoprolol
Metoprolol succinate
Formoterol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
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
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012