Beta Blockers for the Treatment of Asthma

NCT ID: NCT01074853

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-03-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Propranolol

Chronic dose escalation of propranolol over period of 6 to 8 weeks.

Group Type: EXPERIMENTAL

propranolol

Intervention Type: DRUG

10mg twice daily escalated to 80mg once daily

Placebo

Matched placebo used for dose escalation period of 6 to 8 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Matched placebo

Interventions

propranolol

10mg twice daily escalated to 80mg once daily

Intervention Type: DRUG

placebo

Matched placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role: collaborator

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

Brian J Lipworth

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian J Lipworth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Locations

Asthma and Allergy Research Group, Unviersity of Dundee

Dundee, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 23593932 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26123421 (View on PubMed)

Other Identifiers

PAW004

Identifier Type: -

Identifier Source: org_study_id