Pulmonary Disease, Chronic ObstructivePhase 4NCT03370835
Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD
A Phase 4 study testing Metoprolol succinate ER and Carvedilol in people with Pulmonary Disease, Chronic Obstructive and Asthma, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Asthma, Adverse Effect of Beta-adrenoreceptor Antagonists
- What is being tested?
- Metoprolol succinate ER and Carvedilol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA West Los Angeles Medical Center
Los Angeles, California, 90073
About this study
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
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
- Being tested
- Metoprolol succinate ER, Carvedilol
- Keywords
- Beta-Blocker, Chronic Obstructive Pulmonary Disease, COPD, Cardioselective
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol succinate ERDrug
Cardioselective beta-blocker
CarvedilolDrug
Non-cardioselective beta-blocker
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Metoprolol succinate ER; Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in FEV1
Measured: 0, 4, 8, 14, 18 weeks
Secondary outcomes (1)
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
Measured: 0-4, 4-8, 10-14, 14-18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study startJun 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Freny V Mody, MD, Principal investigator, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370835
- Sponsor's protocol ID
- 0027
- Status last verified
- Dec 2017
- First submitted
- 20 Dec 2016
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03370835
- Acronym / sponsor ID
- 0027
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma, Adverse Effect of Beta-adrenoreceptor Antagonists
- Keywords
- Beta-Blocker, Chronic Obstructive Pulmonary Disease, COPD, Cardioselective
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Collaborators
- AstraZeneca
- Study start
- Jun 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Metoprolol succinate ER, Drug: CarvedilolMetoprolol-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 |
| Sequence 2 | Active comparator | Drug: Metoprolol succinate ER, Drug: CarvedilolCarvedilol 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metoprolol succinate ERCardioselective beta-blocker | Drug | Sequence 1, Sequence 2 |
| CarvedilolNon-cardioselective beta-blocker | Drug | Sequence 1, Sequence 2 |
Primary outcome
Percent Change in FEV1
Time frame: 0, 4, 8, 14, 18 weeks
1 secondary outcome
Mean dose
Time frame: 0-4, 4-8, 10-14, 14-18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freny V Mody, MD principal investigator
VA Greater Los Angeles Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoprolol succinate ER and Carvedilol in people with Pulmonary Disease, Chronic Obstructive and Asthma, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in FEV1 (time frame: 0, 4, 8, 14, 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.