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Beta Blocker Therapy in Mild to Moderate Asthmatics (ANDA1)

This study is currently recruiting participants.
Verified June 2012 by University of Dundee
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
William J Anderson, University of Dundee
ClinicalTrials.gov Identifier:
NCT01544634
First received: February 24, 2012
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Asthma
 Drug: Propranolol
Drug: Placebo
Drug: Qvar 50
Drug: Qvar 100
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Change in Histamine provocative concentration causing 20% fall in FEV1 (PC20)at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
    Measurement of airway hyper-reactivity (a hallmark of asthma).


Secondary Outcome Measures:
  • Change in Impulse oscillometry parameters at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
    Change in: Resistance at 5Hz, Resistance at 20Hz, Reactance at 5Hz, Frequency of resonance, Area under reactance curve.

  • Change in Spirometry parameters at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
    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 resting heart rate at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: Yes ]
    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 resting blood pressure at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: Yes ]
    Blood pressure will be monitored at each visit, or if patients develop symptoms that may be due to low blood pressure.

  • Change in exhaled tidal nitric oxide levels at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Change in overnight urinary cortisol/creatinine ratio (OUCC) at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: March 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544634

Contacts
Contact: William J Anderson, MBChB 00441382496440 w.j.anderson@dundee.ac.uk

Locations
United Kingdom
Asthma and Allergy Research Group, University of Dundee Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Contact: William J Anderson, MBChB     441382496440     w.j.anderson@dundee.ac.uk    
Contact: Patricia Burns, BSc     441382496440     p.burns@dundee.ac.uk    
Principal Investigator: William J Anderson, MBChB            
Sponsors and Collaborators
University of Dundee
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
  More Information

Publications:

Responsible Party: William J Anderson, Clinical Research Fellow, University of Dundee
ClinicalTrials.gov Identifier: NCT01544634     History of Changes
Other Study ID Numbers: 2011RC16, 2011-002512-89
Study First Received: February 24, 2012
Last Updated: June 11, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:
Asthma
Propranolol
Inhaled corticosteroids
Steroid sparing agent
Airway hyper-responsiveness

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Adrenergic beta-Antagonists
Propranolol
Beclomethasone
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013