Overview

Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
Summary
Use of beta-blockers has proven beneficial in patients with hypertension, heart failure, and in people who have suffered a heart attack. The use in patients who have Chronic Obstructive Pulmonary Disease (COPD) and reactive airway disease, however, has been limited due to possible side effects such as worsening of lung function or increasing airway spasms and asthma attacks. The purpose of this study is to find out if patients with COPD can tolerate being on a beta-blocker at doses recommended for the treatment of heart disease conditions. This study also seeks to find out if a selective beta-1 receptor beta-blocker is better than a non-selective beta-blocker in patients with mild to moderate COPD.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
VA Greater Los Angeles Healthcare System
Collaborator:
AstraZeneca
Treatments:
Carvedilol
Metoprolol
Criteria
Inclusion Criteria:

- 40 years of age or older

- Mild to moderate COPD as defined by the American Thoracic Society

- Current treatment with a beta-blocker for either hypertension, myocardial infarction,
or congestive heart failure.

Exclusion Criteria:

- Recent (within 30 days) COPD exacerbation or requirement for oral steroid therapy
within the last 6 months

- Any history of ventilator support requirement for COPD

- Patients with asthma or reactive airway disease (RAD) defined as obstructive lung
disease with a >15% improvement in FEV1 with beta-agonist therapy

- Relative or absolute contraindication to beta-blocker therapy

- Exposure to any investigational drugs within the previous 30 days

- Patients with any concurrent disease or condition, which in the judgment of the
investigator would make the patient inappropriate for participation in the study were
excluded from this study