Beta Blockers for the Treatment of Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074853
• Other study ID #: PAW004
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• propranolol
10mg twice daily escalated to 80mg once daily
• placebo
Matched placebo

Locations

Country	Name	City	State
United Kingdom	Asthma and Allergy Research Group, Unviersity of Dundee	Dundee

Sponsors (2)

Lead Sponsor	Collaborator
University of Dundee	Chief Scientist Office of the Scottish Government

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics.		6 weeks