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OpenTrials
Completed

NCT Number: NCT01074853

Beta Blockers for the Treatment of Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asthma and Allergy Research Group, Unviersity of Dundee

Dundee, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propranolol

Drug

10mg twice daily escalated to 80mg once daily

Placebo

Drug

Matched placebo

Primary outcomes

  1. To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics.

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • Chief Scientist Office of the Scottish Government

Registry information

Official study title

Evaluation of Beta Blockers for the Treatment of Asthma. A Randomised Controlled Trial of Propranolol

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 24, 2010
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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