Beta Blockers for the Treatment of Asthma
This study has been completed.
Sponsor:
University of Dundee
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
ClinicalTrials.gov Identifier:
NCT01074853
First received: February 23, 2010
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: propranolol Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Evaluation of Beta Blockers for the Treatment of Asthma. A Randomised Controlled Trial of Propranolol |
Resource links provided by NLM:
Further study details as provided by University of Dundee:
Primary Outcome Measures:
- To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | May 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Propranolol
Chronic dose escalation of propranolol over period of 6 to 8 weeks.
|
Drug: propranolol
10mg twice daily escalated to 80mg once daily
|
|
Placebo Comparator: Placebo
Matched placebo used for dose escalation period of 6 to 8 weeks
|
Drug: placebo
Matched placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074853
Locations
| United Kingdom | |
| Asthma and Allergy Research Group, Unviersity of Dundee | |
| Dundee, United Kingdom, DD1 9SY | |
Sponsors and Collaborators
University of Dundee
Chief Scientist Office of the Scottish Government
Investigators
| Principal Investigator: | Brian J Lipworth, MD | University of Dundee |
More Information
No publications provided
| Responsible Party: | Brian J Lipworth, Professor, University of Dundee |
| ClinicalTrials.gov Identifier: | NCT01074853 History of Changes |
| Other Study ID Numbers: | PAW004 |
| Study First Received: | February 23, 2010 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Adrenergic beta-Antagonists Propranolol |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on May 21, 2013