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
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: propranolol
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Beta Blockers for the Treatment of Asthma. A Randomised Controlled Trial of Propranolol

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propranolol
Chronic dose escalation of propranolol over period of 6 to 8 weeks.
Drug: propranolol
10mg twice daily escalated to 80mg once daily
Placebo Comparator: Placebo
Matched placebo used for dose escalation period of 6 to 8 weeks
Drug: placebo
Matched placebo

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074853

Locations
United Kingdom
Asthma and Allergy Research Group, Unviersity of Dundee
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: Brian J Lipworth, MD University of Dundee
  More Information

No publications provided by University of Dundee

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian J Lipworth, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT01074853     History of Changes
Other Study ID Numbers: PAW004
Study First Received: February 23, 2010
Last Updated: February 6, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 22, 2014