Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370835
• Other study ID #: 0027
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2016
• Last updated: December 7, 2017
• Start date: June 2004
• Est. completion date: June 2008

Study information

• Verified date: December 2017
• Source: VA Greater Los Angeles Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Effect of Beta-adrenoreceptor Antagonists
• Asthma
• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Metoprolol succinate ER
Cardioselective beta-blocker
• Carvedilol
Non-cardioselective beta-blocker

Locations

Country	Name	City	State
United States	VA West Los Angeles Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in FEV1		0, 4, 8, 14, 18 weeks
Secondary	Mean dose	Mean dose of beta-blocker achieved during low (weeks 0-4 and 10-14) and high (weeks 4-8, 14-18) treatment period	0-4, 4-8, 10-14, 14-18 weeks