Evaluation of Beta Blockers for the Treatment of Asthma. A randomised controlled trial of propranolol.

Phase 1

Conditions: asthma
MedDRA version: 12.1Level: LLTClassification code 10003553Term: Asthma

Registration Number: EUCTR2009-017356-28-GB

Lead Sponsor: niversity of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

Male and female volunteers with stable mild intermittent or mild persistent asthma. Stable defined as: FEV1 >80% predicted with diurnal FEV1 variation <30% when LABA washed out. Methacholine PC20 <4mg/ml.
Male and female participants, aged between 18 to 65.
Ability to perform spirometry, IOS, bronchial challenge and all domiciliary measurements.
Ability to obtain Informed consent.
Mild to Moderate Asthmatics taking =1000µg BDP per day or equivalent.
Withold LABAs for 1 week prior to study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Uncontrolled symptoms of asthma.
Resting BP<110 systolic or HR<60.
Pregnancy or lactation.
Known or suspected sensitivity to the IMP(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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish whether chronic dosing with beta-blockers reduces airway inflammation in mild-to-moderate asthmatics on inhaled corticosteriods.;Secondary Objective: ;Primary end point(s): Primary endpoint: Change in methacholine PC20.<br>Secondary endpoints: Change in Histamine PC20, AUC for recovery post methacholine and histamine challenge, Full Spirometry, Impulse Oscillometry (IOS), Serum K+, brain derived neurotrophic factor (BDNF), eosinophil derived neurotoxin (EDN), Eosinophil Cationic Protein (ECP), Cyclic adenosine monophosphate (cAMP), beta-2 genotyping, beta blocker assays, Blood Pressure and Heart Rate.<br>

Secondary Outcome Measures