Beta Blocker Therapy in Mild to Moderate Asthmatics

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: Propranolol; Drug: Qvar 50; Drug: Qvar 100

• Registration Number: NCT01544634
• Lead Sponsor: University of Dundee

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-02-29
• Study First Posted: 2012-03-06
• Study Start: 2012-04-04
• Primary Completion: 2013-05-25
• Study Completion: 2013-05-25
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo + high dose Qvar	Placebo	-
Propranolol + Low dose Qvar	Qvar 50	-
Placebo + high dose Qvar	Qvar 100	-
Propranolol + Low dose Qvar	Propranolol	-

Primary Outcome Measures

Name	Time	Method
Change in Histamine provocative concentration causing 20% fall in FEV1 (PC20)at 6 weeks	Change from baseline to 6 weeks	Measurement of airway hyper-reactivity (a hallmark of asthma).

Secondary Outcome Measures

Name	Time	Method
Change in resting heart rate at 6 weeks	Change from baseline to 6 weeks	Abosolute change in heart rate at 6 weeks will be a secondary outcome. Participants will measure their own heart rate at home on a daily basis and compare this to a given cut-off value, below which they will be advised to contact a trial doctor.
Change in overnight urinary cortisol/creatinine ratio (OUCC) at 6 weeks	Change from baseline to 6 weeks	Systemic effects from inhaled corticosteroids can be measured using OUCC.
Change in symptom scores (Asthma control questionnaire and Asthma quality of life questionnaire) at 6 weeks	Change from baseline to 6 weeks
Change in Spirometry parameters at 6 weeks	Change from baseline to 6 weeks	Change in: Forced expiratory volume in 1 second (FEV1); forced vital capacity (FVC); forced expriatory flow between 25-75% of vital capacity; FEV1/FVC ratio.
Change in Impulse oscillometry parameters at 6 weeks	Change from baseline to 6 weeks	Change in: Resistance at 5Hz, Resistance at 20Hz, Reactance at 5Hz, Frequency of resonance, Area under reactance curve.
Change in exhaled tidal nitric oxide levels at 6 weeks	Change from baseline to 6 weeks
Change in resting blood pressure at 6 weeks	Change from baseline to 6 weeks	Blood pressure will be monitored at each visit, or if patients develop symptoms that may be due to low blood pressure.

Trial Locations

Locations (1)

Asthma and Allergy Research Group, University of Dundee; 🇬🇧 Dundee, Scotland, United Kingdom