Beta Blocker Therapy in Mild to Moderate Asthmatics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-04

Study Completion Date

2013-05-25

Brief Summary

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Current asthma medicines include inhalers. A common type of inhaler is called a 'beta-agonist' (e.g. salbutamol). They improve asthma symptoms by stimulating areas in the airway causing it to widen. Although these drugs are useful short term, long term use can make asthma worse in some people.

'Beta-blockers' are the complete opposite type of medication. Just now they are avoided in patients with asthma. Beta-blockers cause problems in asthmatics in the short term, including severe asthma attacks.

The other mainstay of inhaler treatment for asthma is inhaled steroid or 'preventer' medication. These work by dampening down the inflammation in the lungs that occurs in asthma.

New research has suggested that longer term use of beta-blockers can also reduce airway inflammation which may improve asthma control. This research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. At the moment the investigators are studying to see if there is a benefit of beta-blocker use for asthma over and above asthmatics own usual doses of inhaled steroids.

In this study, the investigators will be trying to find out if adding a beta blocker to a smaller dose of steroid inhaler has the same effect on asthma control as just using a higher dose of steroid inhaler by itself.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Propranolol + Low dose Qvar

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

Propranolol: 10mg bd for 1 week, 20mg bd for 2 weeks, 80mg MR for 4 weeks.

Qvar 50

Intervention Type DRUG

Qvar 50, 1 puff bd for 6 weeks

Placebo + high dose Qvar

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets: 1 tab bd for 2 weeks, 1 tab od for 4 weeks

Qvar 100

Intervention Type DRUG

Qvar 100, 2 puffs bd for 6 weeks

Interventions

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Propranolol

Propranolol: 10mg bd for 1 week, 20mg bd for 2 weeks, 80mg MR for 4 weeks.

Intervention Type DRUG

Placebo

Placebo tablets: 1 tab bd for 2 weeks, 1 tab od for 4 weeks

Intervention Type DRUG

Qvar 50

Qvar 50, 1 puff bd for 6 weeks

Intervention Type DRUG

Qvar 100

Qvar 100, 2 puffs bd for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stable mild to moderate asthma
* Histamine PC20 \</= 8mg/ml
* Receiving inhaled corticosteroid 0-1000ug daily (BDP equivalent dose)
* FEV1 \> 60% predicted
* Diurnal variability \< 30%
* Reliever use \</= 8puffs/day
* ECG demonstrating sinus rhythm

Exclusion Criteria

* Uncontrolled symptoms of asthma
* Systolic BP\<110mmHg
* Heart rate\<60bpm
* Pregnancy or lactation
* Heart block
* Heart rate limiting medications currently prescribed
* Asthma exacerbation within 6 months of study commencement

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No