Chronic Obstructive Pulmonary DiseaseBOLDNCT00745043
Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study
A study testing bronchodilator response in people with Chronic Obstructive Pulmonary Disease, run by Waikato Hospital at 1 site in New Zealand.
Trial summary
Smoking causes both smoking related lung disease (COPD) and ischaemic heart disease. These are very common conditions and many patients have both diseases. Beta-blocker drugs are extensively used in the treatment of angina, high blood pressure and after heart attacks to decrease symptoms and prolong life. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- bronchodilator response
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteNew Zealand
- Study dates
- May 2005to Aug 2007
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD
- > 40 years of age
- > 15 pack year smoking history
Who cannot join
- Contra-indication to beta-blocker use
- Severe COPD FEV1 < 30% or 1 L
- Not responsive the methacholine
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Department of Respiratory Medicine
Hamilton, Waikato Region, 3204
About this study
Official title: Do Beta-blockers Affect the Use of Beta-agonist Inhalers in COPD?
Smoking causes both smoking related lung disease (COPD) and ischaemic heart disease. These are very common conditions and many patients have both diseases. Beta-blocker drugs are extensively used in the treatment of angina, high blood pressure and after heart attacks to decrease symptoms and prolong life. Beta-agonists are used in COPD to decrease breathlessness and improve exercise tolerance. It used to be thought that beta-blockers cannot be used in COPD patients as they may make the breathlessness worse, but it has now been established that they can be used safely. Beta-blocker drugs and beta-agonists have 'opposite' effects on the body and the investigators do not know if they can work together or if they would cancel each other out. The investigators also do not know which of the different types of beta-blockers now available are better for COPD patients. This study will investigate what happens to the airways of people taking both of these drugs.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- bronchodilator response
- Keywords
- COPD, Betablockers, bronchodilator, exercise capacity, methacholine challenge
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchodilator responseDrug
| Study group | Role | What they receive |
|---|---|---|
| R302 | Placebo comparator | Daily placebo capsules Receives: Drug: bronchodilator response |
| R303 | Active comparator | Daily metoprolol 95mg capsules Receives: Drug: bronchodilator response |
| R304 | Active comparator | Daily propranolol 80mg capsules Receives: Drug: bronchodilator response |
| Open Label | Active comparator | Daily Metoprolol 190mg capsules Receives: Drug: bronchodilator response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchodilator response to salbutamol after beta-blockers
Measured: 7-10 days
Incremental Shuttle Walk Test Result after taking beta-blockers
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startMay 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waikato Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Waikato Hospital Research Fund
- Investigators
- Bob Hancox, MD FRACP, Study director, Waikato Hospital Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745043
- Sponsor's protocol ID
- NTX/05/04/035
- Acronym
- BOLD
- Status last verified
- Aug 2008
- First submitted
- 29 Aug 2008
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Beta-blockers Affect the Use of Beta-agonist Inhalers in COPD?
- ClinicalTrials.gov ID
- NCT00745043
- Acronym / sponsor ID
- BOLD / NTX/05/04/035
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Betablockers, bronchodilator, exercise capacity, methacholine challenge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Waikato HospitalUniversity, hospital or other
- Collaborators
- Waikato Hospital Research Fund
- Study start
- May 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 1 Sep 2008 (estimated)
- 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.
Smoking causes both smoking related lung disease (COPD) and ischaemic heart disease. These are very common conditions and many patients have both diseases. Beta-blocker drugs are extensively used in the treatment of angina, high blood pressure and after heart attacks to decrease symptoms and prolong life. Beta-agonists are used in COPD to decrease breathlessness and improve exercise tolerance. It used to be thought that beta-blockers cannot be used in COPD patients as they may make the breathlessness worse, but it has now been established that they can be used safely. Beta-blocker drugs and beta-agonists have 'opposite' effects on the body and the investigators do not know if they can work together or if they would cancel each other out. The investigators also do not know which of the different types of beta-blockers now available are better for COPD patients. This study will investigate what happens to the airways of people taking both of these drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| R302 | Placebo comparator | Drug: bronchodilator responseDaily placebo capsules |
| R303 | Active comparator | Drug: bronchodilator responseDaily metoprolol 95mg capsules |
| R304 | Active comparator | Drug: bronchodilator responseDaily propranolol 80mg capsules |
| Open Label | Active comparator | Drug: bronchodilator responseDaily Metoprolol 190mg capsules |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of COPD
- > 40 years of age
- > 15 pack year smoking history
Key exclusion criteria (3 listed)
- Contra-indication to beta-blocker use
- Severe COPD FEV1 < 30% or 1 L
- Not responsive the methacholine
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 |
|---|---|---|
| bronchodilator response | Drug | Open Label, R302, R303, R304 |
Primary outcome
Bronchodilator response to salbutamol after beta-blockers
Time frame: 7-10 days
Incremental Shuttle Walk Test Result after taking beta-blockers
Time frame: 7-10 days
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 29 Jul 2024.
Related trials for Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruiting
High-Intensity Interval Alternating Concentric-Eccentric Training in Chronic Respiratory Disease
Chronic Respiratory Disease, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Active, not recruitingPhase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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.
Bob Hancox, MD FRACP study director
Waikato Hospital Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchodilator response in people with Chronic Obstructive Pulmonary Disease, run by Waikato Hospital at 1 site in New Zealand.
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 3 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 29 Jul 2024. 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 New Zealand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Bronchodilator response to salbutamol after beta-blockers (time frame: 7-10 days). The study lists 2 primary outcomes in all. 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 29 Jul 2024.