Beta Blocker Therapy in Mild to Moderate Asthmatics (ANDA1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01544634
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : March 30, 2018
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
William J Anderson, 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Propranolol Drug: Placebo Drug: Qvar 50 Drug: Qvar 100 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Any Steroid Sparing Effect of Beta Blocker Therapy on Airway Hyper-responsiveness in Stable, Mild to Moderate Asthmatics
Actual Study Start Date : April 4, 2012
Actual Primary Completion Date : May 25, 2013
Actual Study Completion Date : May 25, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01544634

United Kingdom
Asthma and Allergy Research Group, University of Dundee
Dundee, Scotland, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Chief Scientist Office of the Scottish Government
Principal Investigator: William J Anderson, MBChB University of Dundee
Study Director: Brian J Lipworth, MD University of Dundee

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: William J Anderson, Clinical Research Fellow, University of Dundee Identifier: NCT01544634     History of Changes
Other Study ID Numbers: 2011RC16
2011-002512-89 ( EudraCT Number )
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by William J Anderson, University of Dundee:
Inhaled corticosteroids
Steroid sparing agent
Airway hyper-responsiveness

Additional relevant MeSH terms:
Respiratory Hypersensitivity
Respiratory Tract Diseases
Hypersensitivity, Immediate
Immune System Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents