Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

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

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

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

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

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

Martini Hospital, Groningen 9700 RM, Netherlands; Recruiting

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