Back to resultsMetoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Metoprolol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)
Eligibility 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
Sites / Locations
- Martini HospitalRecruiting
Outcomes
Primary Outcome Measures
Difference in airway reactivity after treatment with metoprolol compared to placebo.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00288548
First Posted
February 7, 2006
Last Updated
February 17, 2006
Sponsor
Martini Hospital Groningen
1. Study Identification
Unique Protocol Identification Number
NCT00288548
Brief Title
Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Martini Hospital Groningen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Primary Outcome Measure Information:
Title
Difference in airway reactivity after treatment with metoprolol compared to placebo.
Secondary Outcome Measure Information:
Title
Effect of formoterol on airway reactivity comparing metoprolol with placebo.
Title
Borg-scores during provocation test
Title
Peak-flow measurements
Title
CCQ-scores
Title
Exacerbation rate and rescue medication use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirjam Mensing, Drs.
Phone
+31 50 524 7817
Email
M.Mensing@MZH.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
René Aalbers, MD, PhD
Organizational Affiliation
Martini Hospital Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martini Hospital
City
Groningen
ZIP/Postal Code
9700 RM
Country
Netherlands
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)
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