Beta Blockers for the Treatment of Asthma

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.

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: propranolol; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
    • Asthma and Allergy Research Group, Unviersity of Dundee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Dundee
• Collaborators: Chief Scientist Office of the Scottish Government
• Investigators: Principal Investigator: Brian J Lipworth, MD, University of Dundee

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 23, 2010
• First Submitted That Met QC Criteria: February 23, 2010
• First Posted (Estimate): February 24, 2010

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: PAW004