Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00288548

Enrollment

Registered

2006-02-08

Start date

2006-02-28

Completion date

Unknown

Last updated

2006-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

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.

Interventions

DRUGMetoprolol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Difference in airway reactivity after treatment with metoprolol compared to placebo.	—

Secondary

Measure	Time frame
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	—

Countries

Netherlands

Contacts

Primary ContactMirjam Mensing, Drs.

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026