NCT01074853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started May 2010

Typical duration for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

February 23, 2010

Last Update Submit

April 10, 2019

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

    6 weeks

Study Arms (2)

Propranolol

EXPERIMENTAL

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

Drug: propranolol

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

propranololDRUG

10mg twice daily escalated to 80mg once daily

Propranolol
placeboDRUG

Matched placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma and Allergy Research Group, Unviersity of Dundee

Dundee, DD1 9SY, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 23593932RESULT

  • 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.

    PMID: 26123421DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Brian J Lipworth, MD

    University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

May 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 12, 2019

Record last verified: 2019-04

Locations

GB(1)