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Completed

NCT Number: NCT01544634

Beta Blocker Therapy in 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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asthma and Allergy Research Group, University of Dundee

Dundee, Scotland, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propranolol

Drug

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

Placebo

Drug

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

Qvar 50

Drug

Qvar 50, 1 puff bd for 6 weeks

Qvar 100

Drug

Qvar 100, 2 puffs bd for 6 weeks

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Change in exhaled tidal nitric oxide levels at 6 weeks

    Time frame: Change from baseline to 6 weeks

  6. 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.

  7. Change in symptom scores (Asthma control questionnaire and Asthma quality of life questionnaire) at 6 weeks

    Time frame: Change from baseline to 6 weeks

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • Chief Scientist Office of the Scottish Government

Registry information

Official study title

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

Acronym: ANDA1

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 6, 2012
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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