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Completed

NCT Number: NCT03370835

Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Adverse Effect of Beta-adrenoreceptor Antagonists Asthma Bronchial Diseases Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VA West Los Angeles Medical Center

Los Angeles, California, 90073, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metoprolol succinate ER

Drug

Cardioselective beta-blocker

Carvedilol

Drug

Non-cardioselective beta-blocker

Primary outcomes

  1. Percent Change in FEV1

    Time frame: 0, 4, 8, 14, 18 weeks

Secondary outcomes

  1. Mean dose

    Time frame: 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

Sponsors and collaborators

Lead sponsor

VA Greater Los Angeles Healthcare System

Fed

Collaborators

  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Dec 12, 2017
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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