Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

• Sponsor: Martini Hospital Groningen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00288548
• Collaborator: (none)
• Enrollment: 45
• Location: 1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Feb 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Martini Hospital	Groningen		Netherlands	9700 RM

Sponsors and Collaborators

• Martini Hospital Groningen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00288548
• Other Study ID Numbers: MeFCo2
• First Posted: Feb 8, 2006
• Last Update Posted: Feb 20, 2006
• Last Verified: Feb 1, 2006

• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Metoprolol

Study Results

No Results Posted as of Feb 20, 2006