Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT00288548
Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Metoprolol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Martini Hospital Groningen at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Metoprolol
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2006to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- being able to perform technically acceptable pulmonary function tests
- signed informed consent
- systolic blood pressure equal to 130 or greater
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Martini Hospital
Groningen, Provincie Groningen, 9700 RM
About this study
Official title: Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD
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.
- Being tested
- Metoprolol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in airway reactivity after treatment with metoprolol compared to placebo.
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Martini Hospital Groningen
- Sponsor type
- University, hospital or other
- Investigators
- René Aalbers, MD, PhD, Principal investigator, Martini Hospital Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288548
- Sponsor's protocol ID
- MeFCo2
- Status last verified
- Feb 2006
- First submitted
- 7 Feb 2006
- Last updated
- 20 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD
- ClinicalTrials.gov ID
- NCT00288548
- Acronym / sponsor ID
- MeFCo2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants
- Lead sponsor
- Martini Hospital GroningenUniversity, hospital or other
- Study start
- Feb 2006
- First posted
- 8 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metoprolol | Drug | – |
Primary outcome
Difference in airway reactivity after treatment with metoprolol compared to placebo.
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René Aalbers, MD, PhD principal investigator
Martini Hospital Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoprolol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Martini Hospital Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mirjam Mensing, Drs. (+31 50 524 7817, M.Mensing@MZH.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in airway reactivity after treatment with metoprolol compared to placebo.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2006.