Chronic Obstructive Pulmonary Disease (COPD) | Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD) research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Obstructive Pulmonary Disease (COPD)
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: February 2006
Phase: Phase 4
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.
Study sponsors, principal investigator, and references
Principal Investigator: René Aalbers, MD, PhD
Lead Sponsor: Martini Hospital Groningen