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Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

Information source: Martini Hospital Groningen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)

Intervention: Metoprolol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Martini Hospital Groningen

Official(s) and/or principal investigator(s):
René Aalbers, MD, PhD, Principal Investigator, Affiliation: Martini Hospital Groningen

Overall contact:
Mirjam Mensing, Drs., Phone: +31 50 524 7817, Email: M.Mensing@MZH.nl

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.

Clinical Details

Official title: Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Secondary outcome:

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

Eligibility

Minimum age: 40 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Mirjam Mensing, Drs., Phone: +31 50 524 7817, Email: M.Mensing@MZH.nl

Martini Hospital, Groningen 9700 RM, Netherlands; Recruiting
Additional Information

Starting date: February 2006
Last updated: February 17, 2006

Page last updated: August 23, 2015

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