AsthmaPhase 2NCT01074853
Beta Blockers for the Treatment of Asthma
A Phase 2 study testing propranolol in people with Asthma, run by University of Dundee at 1 site in United Kingdom.
Trial summary
Current asthma medicines include inhalers. A common inhaler used in asthma is called a beta-agonist (for example salbutamol). They improve asthma symptoms by stimulating areas in the human airway resulting in widening of the human airway. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- propranolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to Mar 2012
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female volunteers with stable mild intermittent or mild persistent asthma.
- Stable defined as: FEV1 (Forced Expiratory Volume in 1second) >80% predicted with diurnal FEV1 variation <30% when LABA (Long Acting Beta Agonist) washed out.
- Methacholine PC20 <4mg/ml.
- Ability to perform spirometry, IOS (Impulse Oscillometry), bronchial challenge and all domiciliary measurements.
- Ability to obtain Informed consent.
- Mild to Moderate Asthmatics taking ≤1000μg BDP (Beclomethasone Diproprionate) per day or equivalent.
- Withhold LABAs for 1 week prior to study.
Who cannot join
- Uncontrolled symptoms of asthma.
- Resting BP (Blood Pressure) <110 systolic or HR (Heart Rate)<60.
- Pregnancy or lactation.
- Known or suspected sensitivity to the IMP (Investigational Medicinal Product)(s).
- Inability to comply with protocol.
- Any degree of heart block.
Show all 9Show fewer
- Rate limiting medication including β blockers, rate limiting Calcium - Channel Blockers and Amiodarone.
- Any other clinically significant medical condition that may either endanger the health or safety of the participant, or jeopardise the protocol.
- An asthma exacerbation within the last 6 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Asthma and Allergy Research Group, Unviersity of Dundee
Dundee, DD1 9SY
About this study
Official title: Evaluation of Beta Blockers for the Treatment of Asthma. A Randomised Controlled Trial of Propranolol
Current asthma medicines include inhalers. A common inhaler used in asthma is called a beta-agonist (for example salbutamol). They improve asthma symptoms by stimulating areas in the human airway resulting in widening of the human airway. Although these drugs are useful after the first dose, longterm use can cause worsening asthma symptoms.
Beta-blockers are the complete opposite type of medication. Just now they are avoided in patients with asthma as after the first dose they can cause airway narrowing and cause an asthma attack.
Read more
New research has suggested that long term use of beta-blockers can reduce airway inflammation which can improve asthma control and improve symptoms.
This research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. What the investigators want to do is see if the same benefit of beta-blocker use is asthma can be seen in people who take inhaled steroids.
- Conditions
- Asthma
- Being tested
- propranolol, placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
10mg twice daily escalated to 80mg once daily
placeboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | Chronic dose escalation of propranolol over period of 6 to 8 weeks. Receives: Drug: propranolol |
| Placebo | Placebo comparator | Matched placebo used for dose escalation period of 6 to 8 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Responsible party
- Principal investigator, Brian J Lipworth, University of Dundee
- Investigators
- Brian J Lipworth, MD, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074853
- Sponsor's protocol ID
- PAW004
- Status last verified
- Apr 2019
- First submitted
- 23 Feb 2010
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Short PM, Williamson PA, Anderson WJ, Lipworth BJ. Randomized placebo-controlled trial to evaluate chronic dosing effects of propranolol in asthma. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1308-14. doi: 10.1164/rccm.201212-2206OC.
PubMed 23593932Short PM, Anderson WJ, Manoharan A, Lipworth BJ. Usefulness of impulse oscillometry for the assessment of airway hyperresponsiveness in mild-to-moderate adult asthma. Ann Allergy Asthma Immunol. 2015 Jul;115(1):17-20. doi: 10.1016/j.anai.2015.04.022.
PubMed 26123421
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Beta Blockers for the Treatment of Asthma. A Randomised Controlled Trial of Propranolol
- ClinicalTrials.gov ID
- NCT01074853
- Acronym / sponsor ID
- PAW004
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Study start
- May 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 Feb 2010 (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.
Current asthma medicines include inhalers. A common inhaler used in asthma is called a beta-agonist (for example salbutamol). They improve asthma symptoms by stimulating areas in the human airway resulting in widening of the human airway. Although these drugs are useful after the first dose, longterm use can cause worsening asthma symptoms.
Beta-blockers are the complete opposite type of medication. Just now they are avoided in patients with asthma as after the first dose they can cause airway narrowing and cause an asthma attack.
New research has suggested that long term use of beta-blockers can reduce airway inflammation which can improve asthma control and improve symptoms.
This research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. What the investigators want to do is see if the same benefit of beta-blocker use is asthma can be seen in people who take inhaled steroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: propranololChronic dose escalation of propranolol over period of 6 to 8 weeks. |
| Placebo | Placebo comparator | Drug: placeboMatched placebo used for dose escalation period of 6 to 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female volunteers with stable mild intermittent or mild persistent asthma.
- Stable defined as: FEV1 (Forced Expiratory Volume in 1second) >80% predicted with diurnal FEV1 variation <30% when LABA (Long Acting Beta Agonist) washed out.
- Methacholine PC20 <4mg/ml.
- Ability to perform spirometry, IOS (Impulse Oscillometry), bronchial challenge and all domiciliary measurements.
- Ability to obtain Informed consent.
Key exclusion criteria (9 listed)
- Uncontrolled symptoms of asthma.
- Resting BP (Blood Pressure) <110 systolic or HR (Heart Rate)<60.
- Pregnancy or lactation.
- Known or suspected sensitivity to the IMP (Investigational Medicinal Product)(s).
- Inability to comply with protocol.
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 |
|---|---|---|
| propranolol10mg twice daily escalated to 80mg once daily | Drug | Propranolol |
| placeboMatched placebo | Drug | Placebo |
Primary outcome
To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics.
Time frame: 6 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 Apr 2019.
- Results publication: PubMed 23593932Short PM, Williamson PA, Anderson WJ, Lipworth BJ. Randomized placebo-controlled trial to evaluate chronic dosing effects of propranolol in asthma. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1308-14. doi: 10.1164/rccm.201212-2206OC.
- Derived from this study: PubMed 26123421Short PM, Anderson WJ, Manoharan A, Lipworth BJ. Usefulness of impulse oscillometry for the assessment of airway hyperresponsiveness in mild-to-moderate adult asthma. Ann Allergy Asthma Immunol. 2015 Jul;115(1):17-20. doi: 10.1016/j.anai.2015.04.022.
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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.
Brian J Lipworth, MD principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing propranolol in people with Asthma, run by University of Dundee at 1 site in United Kingdom.
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 7 inclusion and 9 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 Apr 2019. 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 Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01074853, which also lists 2 linked publications.
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 Apr 2019.