Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03370835

Enrollment

Registered

2017-12-12

Start date

2004-06-30

Completion date

2008-06-30

Last updated

2017-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Beta-Blocker, Chronic Obstructive Pulmonary Disease, COPD, Cardioselective

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.

Interventions

DRUGMetoprolol succinate ER

Cardioselective beta-blocker

DRUGCarvedilol

Non-cardioselective beta-blocker

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percent Change in FEV1	0, 4, 8, 14, 18 weeks

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026