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Beta Blockers for the Treatment of Asthma

This study has been completed.
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
ClinicalTrials.gov Identifier:
NCT01074853
First received: February 23, 2010
Last updated: February 6, 2013
Last verified: February 2013

February 23, 2010
February 6, 2013
May 2010
March 2012   (final data collection date for primary outcome measure)
To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01074853 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Beta Blockers for the Treatment of Asthma
Evaluation of Beta Blockers for the Treatment of Asthma. A Randomised Controlled Trial of Propranolol

Current asthma medicines include inhalers. A common inhaler used in asthma is called a beta-agonist (for example salbutamol). They improve asthma symptoms by stimulating areas in the human airway resulting in widening of the human airway. Although these drugs are useful after the first dose, longterm use can cause worsening asthma symptoms.

Beta-blockers are the complete opposite type of medication. Just now they are avoided in patients with asthma as after the first dose they can cause airway narrowing and cause an asthma attack.

New research has suggested that long term use of beta-blockers can reduce airway inflammation which can improve asthma control and improve symptoms.

This research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. What the investigators want to do is see if the same benefit of beta-blocker use is asthma can be seen in people who take inhaled steroids.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: propranolol
    10mg twice daily escalated to 80mg once daily
  • Drug: placebo
    Matched placebo
  • Experimental: Propranolol
    Chronic dose escalation of propranolol over period of 6 to 8 weeks.
    Intervention: Drug: propranolol
  • Placebo Comparator: Placebo
    Matched placebo used for dose escalation period of 6 to 8 weeks
    Intervention: Drug: placebo
Short PM, Williamson PA, Anderson WJ, Lipworth BJ. Randomized Placebo-controlled Trial to Evaluate Chronic Dosing Effects of Propranolol in Asthma. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1308-14. doi: 10.1164/rccm.201212-2206OC.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female volunteers with stable mild intermittent or mild persistent asthma.
  • Stable defined as: FEV1 (Forced Expiratory Volume in 1second) >80% predicted with diurnal FEV1 variation <30% when LABA (Long Acting Beta Agonist) washed out.
  • Methacholine PC20 <4mg/ml.
  • Ability to perform spirometry, IOS (Impulse Oscillometry), bronchial challenge and all domiciliary measurements.
  • Ability to obtain Informed consent.
  • Mild to Moderate Asthmatics taking ≤1000μg BDP (Beclomethasone Diproprionate) per day or equivalent.
  • Withhold LABAs for 1 week prior to study.

Exclusion Criteria:

  • Uncontrolled symptoms of asthma.
  • Resting BP (Blood Pressure) <110 systolic or HR (Heart Rate)<60.
  • Pregnancy or lactation.
  • Known or suspected sensitivity to the IMP (Investigational Medicinal Product)(s).
  • Inability to comply with protocol.
  • Any degree of heart block.
  • Rate limiting medication including β blockers, rate limiting Calcium - Channel Blockers and Amiodarone.
  • Any other clinically significant medical condition that may either endanger the health or safety of the participant, or jeopardise the protocol.
  • An asthma exacerbation within the last 6 months.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01074853
PAW004
Yes
Brian J Lipworth, University of Dundee
University of Dundee
Chief Scientist Office of the Scottish Government
Principal Investigator: Brian J Lipworth, MD University of Dundee
University of Dundee
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP