Reversal of Acute β-Blocker Induced Bronchoconstriction

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Current therapies for the management of asthma include inhalers. Types of these medications (beta agonists), improve asthma symptoms by stimulating areas (receptors) within the human airway resulting in dilation of the human airway. Whilst these drugs are highly effectively in the immediate setting their longterm use, constantly stimulation of receptors within the airway has been associated with increased asthma exacerbations and rare cases of death.

Conversely medications that block receptors within the human airway (betablockers)have been avoided in asthma.

The main reason for this is because of the possible acute airway narrowing that can occur after soon after administration. However chronic use of betablockers in asthma has recently been shown to be of benefit in reducing airway inflammation which is of great importance in improving asthma control and reducing symptoms.

Despite this early evidence supporting chronic use of beta blockers in asthma, there is concern in 2 major regards:their potential to cause acute airway narrowing (irrespective of longterm benefit) and the possibility that they could block the reliever action of beta agonists.

The objective of this study is to establish how best to reverse the short term effects of a single dose of beta blocker.

This study is designed as a single centre study, with participants attending the department on approximately 3 separate visits (including a screening visit) at approximately 1 weekly intervals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Collaborator: NHS Tayside
• Treatments: Adrenergic beta-Antagonists; Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Propranolol

Criteria

Inclusion Criteria:

• Ability to obtain Informed consent.

• Mild to Moderate Asthmatics taking ≤1000μg BDP per day or equivalent.

• Histamine PC10

• Ability to perform spirometry, IOS, bronchial challenge and all domiciliary measurements.

• Withhold LABAs, montelukast and theophyllines for 1 week prior to study.

• FEV1 >80% predicted with diurnal FEV1 variation <20% post wash out.

Exclusion Criteria:

• Uncontrolled symptoms of asthma.

• Resting BP<110 systolic or HR<60.

• Pregnancy or lactation.

• Known or suspected sensitivity to IMP.

• 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.