Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD

Phase 4

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive; Adverse Effect of Beta-adrenoreceptor Antagonists; Asthma
• Interventions: Drug: Metoprolol succinate ER; Drug: Carvedilol

• Registration Number: NCT03370835
• Lead Sponsor: VA Greater Los Angeles Healthcare System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2016-12-20
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-07
• Last Update Submitted: 2017-12-07
• Study First Posted: 2017-12-12
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	Metoprolol succinate ER	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
Sequence 2	Carvedilol	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
Sequence 2	Metoprolol succinate ER	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
Sequence 1	Carvedilol	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

Primary Outcome Measures

Name	Time	Method
Percent Change in FEV1	0, 4, 8, 14, 18 weeks

Secondary Outcome Measures

Name	Time	Method
Mean dose	0-4, 4-8, 10-14, 14-18 weeks	Mean dose of beta-blocker achieved during low (weeks 0-4 and 10-14) and high (weeks 4-8, 14-18) treatment period

Trial Locations

Locations (1)

VA West Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States