Beta Blocker Therapy in Mild to Moderate Asthmatics (ANDA1)

March 29, 2018 updated by: William J Anderson, University of Dundee

Evaluation of Any Steroid Sparing Effect of Beta Blocker Therapy on Airway Hyper-responsiveness in Stable, Mild to Moderate Asthmatics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Asthma and Allergy Research Group, University of Dundee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propranolol + Low dose Qvar
Drug: Propranolol
Propranolol: 10mg bd for 1 week, 20mg bd for 2 weeks, 80mg MR for 4 weeks.
Drug: Qvar 50
Qvar 50, 1 puff bd for 6 weeks
Active Comparator: Placebo + high dose Qvar
Drug: Placebo
Placebo tablets: 1 tab bd for 2 weeks, 1 tab od for 4 weeks
Drug: Qvar 100
Qvar 100, 2 puffs bd for 6 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Impulse oscillometry parameters at 6 weeks
Time Frame: 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 from baseline to 6 weeks
Change in Spirometry parameters at 6 weeks
Time Frame: 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 from baseline to 6 weeks
Change in resting heart rate at 6 weeks
Time Frame: 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 from baseline to 6 weeks
Change in resting blood pressure at 6 weeks
Time Frame: 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.
Change from baseline to 6 weeks
Change in exhaled tidal nitric oxide levels at 6 weeks
Time Frame: Change from baseline to 6 weeks
Change from baseline to 6 weeks
Change in overnight urinary cortisol/creatinine ratio (OUCC) at 6 weeks
Time Frame: Change from baseline to 6 weeks
Systemic effects from inhaled corticosteroids can be measured using OUCC.
Change from baseline to 6 weeks
Change in symptom scores (Asthma control questionnaire and Asthma quality of life questionnaire) at 6 weeks
Time Frame: Change from baseline to 6 weeks
Change from baseline to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Collaborators

Chief Scientist Office of the Scottish Government

Investigators

  • Principal Investigator: William J Anderson, MBChB, University of Dundee
  • Study Director: Brian J Lipworth, MD, University of Dundee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2012

Primary Completion (Actual)

May 25, 2013

Study Completion (Actual)

May 25, 2013

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

February 29, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011RC16
  • 2011-002512-89 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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