Beta Blockers for the Treatment of Asthma

• ClinicalTrials.gov Identifier: NCT01074853
• Recruitment Status: Completed
• First Posted: February 24, 2010
• Last Update Posted: April 12, 2019
• Sponsor: University of Dundee
• Collaborator: Chief Scientist Office of the Scottish Government
• Information provided by (Responsible Party): Brian J Lipworth, University of Dundee

Study Description

Brief 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. 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 or disease	Intervention/treatment	Phase
Asthma	Drug: propranolol; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of Beta Blockers for the Treatment of Asthma. A Randomised Controlled Trial of Propranolol
• Study Start Date: May 2010
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics. [ Time Frame: 6 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Short 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.

• Responsible Party: Brian J Lipworth, Professor, University of Dundee
• ClinicalTrials.gov Identifier: NCT01074853
• Other Study ID Numbers: PAW004
• First Posted: February 24, 2010
• Last Update Posted: April 12, 2019
• Last Verified: April 2019

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Propranolol; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents