Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

NCT00288548 | Unknown Phase 4

• 1 other identifier: MeFCo2
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Interventions

Metoprolol DRUG

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Martini Hospital Groningen: lead

Study Sites (1)

Martini Hospital

Groningen, Provincie Groningen, 9700 RM, Netherlands

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• René Aalbers, MD, PhD

  Martini Hospital Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirjam Mensing, Drs.

CONTACT

+31 50 524 7817; M.Mensing@MZH.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 8, 2006
• Study Start: February 1, 2006
• Last Updated: February 20, 2006

Record last verified: 2006-02

Locations

NL (1)