Randomized Open-Label Crossover Trial Comparing Tolerability of a Cardioselective Beta-Blocker (Metoprolol-Succinate-ER) and a Non-Cardioselective Beta-Blocker (Carvedilol) in Patients With Chronic Obstructive Pulmonary Disease
Overview
- Phase
- Phase 4
- Intervention
- Metoprolol succinate ER
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- VA Greater Los Angeles Healthcare System
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Percent Change in FEV1
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
Sequence 1
Metoprolol-succinate-ER 25mg daily weeks 0-2, 50mg daily weeks 2-4, 100mg daily weeks 4-6, 200mg daily weeks 6-8, 100mg daily week 9, 50mg daily week 10 Carvedilol 3.125mg twice daily weeks 10-12, 6.25mg twice daily weeks 12-14, 12.5mg twice daily weeks 14-16, 25mg twice daily weeks 16-18
Intervention: Metoprolol succinate ER
Sequence 1
Metoprolol-succinate-ER 25mg daily weeks 0-2, 50mg daily weeks 2-4, 100mg daily weeks 4-6, 200mg daily weeks 6-8, 100mg daily week 9, 50mg daily week 10 Carvedilol 3.125mg twice daily weeks 10-12, 6.25mg twice daily weeks 12-14, 12.5mg twice daily weeks 14-16, 25mg twice daily weeks 16-18
Intervention: Carvedilol
Sequence 2
Carvedilol 3.125mg twice daily weeks 0-2, 6.25mg twice daily weeks 2-4, 12.5mg twice daily weeks 4-6, 25mg twice daily weeks 6-8, 12.5mg twice daily week 9, 6.25mg twice daily week 10 Metoprolol-succinate-ER 25mg daily weeks 10-12, 50mg daily weeks 12-14, 100mg daily weeks 14-16, 200mg daily weeks 16-18
Intervention: Metoprolol succinate ER
Sequence 2
Carvedilol 3.125mg twice daily weeks 0-2, 6.25mg twice daily weeks 2-4, 12.5mg twice daily weeks 4-6, 25mg twice daily weeks 6-8, 12.5mg twice daily week 9, 6.25mg twice daily week 10 Metoprolol-succinate-ER 25mg daily weeks 10-12, 50mg daily weeks 12-14, 100mg daily weeks 14-16, 200mg daily weeks 16-18
Intervention: Carvedilol
Outcomes
Primary Outcomes
Percent Change in FEV1
Time Frame: 0, 4, 8, 14, 18 weeks
Secondary Outcomes
- Mean dose(0-4, 4-8, 10-14, 14-18 weeks)