Back to resultsTolerability of Metoprolol-Succinate-ER and Carvedilol in COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Asthma, Adverse Effect of Beta-adrenoreceptor Antagonists
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metoprolol succinate ER
Carvedilol
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Beta-Blocker, Chronic Obstructive Pulmonary Disease, COPD, Cardioselective
Eligibility Criteria
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
Sites / Locations
- VA West Los Angeles Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sequence 1
Sequence 2
Arm Description
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
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
Outcomes
Primary Outcome Measures
Percent Change in FEV1
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03370835
First Posted
December 20, 2016
Last Updated
December 7, 2017
Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT03370835
Brief Title
Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Asthma, Adverse Effect of Beta-adrenoreceptor Antagonists
Keywords
Beta-Blocker, Chronic Obstructive Pulmonary Disease, COPD, Cardioselective
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
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
Arm Title
Sequence 2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Metoprolol succinate ER
Intervention Description
Cardioselective beta-blocker
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Description
Non-cardioselective beta-blocker
Primary Outcome Measure Information:
Title
Percent Change in FEV1
Time Frame
0, 4, 8, 14, 18 weeks
Secondary Outcome Measure Information:
Title
Mean dose
Description
Mean dose of beta-blocker achieved during low (weeks 0-4 and 10-14) and high (weeks 4-8, 14-18) treatment period
Time Frame
0-4, 4-8, 10-14, 14-18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Freny V Mody, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA West Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD
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