Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD

NCT03370835 | Completed Phase 4

• 1 other identifier: 0027
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent Change in FEV1

  0, 4, 8, 14, 18 weeks

Secondary Outcomes (1)

• Mean dose

  0-4, 4-8, 10-14, 14-18 weeks

Study Arms (2)

Sequence 1

EXPERIMENTAL

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

Drug: Metoprolol succinate ER; Drug: Carvedilol

Sequence 2

ACTIVE COMPARATOR

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

Drug: Metoprolol succinate ER; Drug: Carvedilol

Interventions

Metoprolol succinate ER DRUG

Cardioselective beta-blocker

Sequence 1; Sequence 2

Carvedilol DRUG

Non-cardioselective beta-blocker

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead
• AstraZeneca: collaborator

Study Sites (1)

VA West Los Angeles Medical Center

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

Metoprolol; Carvedilol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Freny V Mody, MD

  VA Greater Los Angeles Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 12, 2017
• Study Start: June 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 12, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)