search
Back to results

Beta Blockers for the Treatment of Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
propranolol
placebo
Sponsored by
University of Dundee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Asthma and Allergy Research Group, Unviersity of Dundee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propranolol

Placebo

Arm Description

Chronic dose escalation of propranolol over period of 6 to 8 weeks.

Matched placebo used for dose escalation period of 6 to 8 weeks

Outcomes

Primary Outcome Measures

To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2010
Last Updated
April 10, 2019
Sponsor
University of Dundee
Collaborators
Chief Scientist Office of the Scottish Government
search

1. Study Identification

Unique Protocol Identification Number
NCT01074853
Brief Title
Beta Blockers for the Treatment of Asthma
Official Title
Evaluation of Beta Blockers for the Treatment of Asthma. A Randomised Controlled Trial of Propranolol
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee
Collaborators
Chief Scientist Office of the Scottish Government

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propranolol
Arm Type
Experimental
Arm Description
Chronic dose escalation of propranolol over period of 6 to 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo used for dose escalation period of 6 to 8 weeks
Intervention Type
Drug
Intervention Name(s)
propranolol
Intervention Description
10mg twice daily escalated to 80mg once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Matched placebo
Primary Outcome Measure Information:
Title
To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Lipworth, MD
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asthma and Allergy Research Group, Unviersity of Dundee
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23593932
Citation
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.
Results Reference
result
PubMed Identifier
26123421
Citation
Short PM, Anderson WJ, Manoharan A, Lipworth BJ. Usefulness of impulse oscillometry for the assessment of airway hyperresponsiveness in mild-to-moderate adult asthma. Ann Allergy Asthma Immunol. 2015 Jul;115(1):17-20. doi: 10.1016/j.anai.2015.04.022.
Results Reference
derived

Learn more about this trial

Beta Blockers for the Treatment of Asthma

We'll reach out to this number within 24 hrs