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Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD

NCT ID: NCT03370835

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-06-30

Brief Summary

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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

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Conditions

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

Keywords

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Beta-Blocker Chronic Obstructive Pulmonary Disease COPD Cardioselective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Metoprolol succinate ER

Intervention Type DRUG

Cardioselective beta-blocker

Carvedilol

Intervention Type DRUG

Non-cardioselective beta-blocker

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

Group Type ACTIVE_COMPARATOR

Metoprolol succinate ER

Intervention Type DRUG

Cardioselective beta-blocker

Carvedilol

Intervention Type DRUG

Non-cardioselective beta-blocker

Interventions

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Metoprolol succinate ER

Cardioselective beta-blocker

Intervention Type DRUG

Carvedilol

Non-cardioselective beta-blocker

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

VA Greater Los Angeles Healthcare System

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Freny V Mody, MD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System

Locations

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VA West Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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0027

Identifier Type: -

Identifier Source: org_study_id