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Status unknownNCT00288548Updated Feb 20, 2006

Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 interventional study of Metoprolol in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Martini Hospital Groningen. Status unknown at 1 site in Netherlands. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-02-20.

Sponsored by Martini Hospital Groningen · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 45 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Martini Hospital Groningen is the lead sponsor of 14 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
45 participants

Interventions

  • DrugMetoprolol
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Martini Hospital
    Groningen, 9700 RM, Netherlands
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00288548
Lead sponsor
Martini Hospital Groningen
First posted
Feb 8, 2006
Start date
Feb 2006
Last update
Feb 20, 2006

Study contacts

Mirjam Mensing, Drs.
Contact
M.Mensing@MZH.nl
+31 50 524 7817
René Aalbers, MD, PhD
principal investigator · Martini Hospital Groningen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2006. You cannot join it, but the record below documents what was studied.

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