Clinical trial NCT01074853: Beta Blockers for the Treatment of Asthma
Official title: Evaluation of Beta Blockers for the Treatment of Asthma. A Randomised Controlled Trial of Propranolol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: Chief Scientist Office of the Scottish Government
First posted: 2010-02-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Asthma and Allergy Research Group, Unviersity of Dundee
Study officials:
affiliation: University of Dundee
name: Brian J Lipworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.