NCT01544634

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Apr 2012

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 24, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
29 days until next milestone

Study Start

First participant enrolled

April 4, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2013

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

February 24, 2012

Last Update Submit

March 29, 2018

Conditions

Asthma

Keywords

AsthmaPropranololInhaled corticosteroidsSteroid sparing agentAirway hyper-responsiveness

Outcome Measures

Primary Outcomes (1)

  • Change in Histamine provocative concentration causing 20% fall in FEV1 (PC20)at 6 weeks

    Measurement of airway hyper-reactivity (a hallmark of asthma).

    Change from baseline to 6 weeks

Secondary Outcomes (7)

  • Change in Impulse oscillometry parameters at 6 weeks

    Change from baseline to 6 weeks

  • Change in Spirometry parameters at 6 weeks

    Change from baseline to 6 weeks

  • Change in resting heart rate at 6 weeks

    Change from baseline to 6 weeks

  • Change in resting blood pressure at 6 weeks

    Change from baseline to 6 weeks

  • Change in exhaled tidal nitric oxide levels at 6 weeks

    Change from baseline to 6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Propranolol + Low dose Qvar

EXPERIMENTAL
Drug: PropranololDrug: Qvar 50

Placebo + high dose Qvar

ACTIVE COMPARATOR
Drug: PlaceboDrug: Qvar 100

Interventions

PropranololDRUG

Propranolol: 10mg bd for 1 week, 20mg bd for 2 weeks, 80mg MR for 4 weeks.

Propranolol + Low dose Qvar
PlaceboDRUG

Placebo tablets: 1 tab bd for 2 weeks, 1 tab od for 4 weeks

Placebo + high dose Qvar
Qvar 50DRUG

Qvar 50, 1 puff bd for 6 weeks

Propranolol + Low dose Qvar
Qvar 100DRUG

Qvar 100, 2 puffs bd for 6 weeks

Placebo + high dose Qvar

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma and Allergy Research Group, University of Dundee

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Related Publications (7)

  • Morales DR, Guthrie B, Lipworth BJ, Donnan PT, Jackson C. Prescribing of beta-adrenoceptor antagonists in asthma: an observational study. Thorax. 2011 Jun;66(6):502-7. doi: 10.1136/thoraxjnl-2011-200067. Epub 2011 Apr 1.

    PMID: 21459857BACKGROUND

  • Lin R, Peng H, Nguyen LP, Dudekula NB, Shardonofsky F, Knoll BJ, Parra S, Bond RA. Changes in beta 2-adrenoceptor and other signaling proteins produced by chronic administration of 'beta-blockers' in a murine asthma model. Pulm Pharmacol Ther. 2008;21(1):115-24. doi: 10.1016/j.pupt.2007.06.003. Epub 2007 Jul 4.

    PMID: 17689122BACKGROUND

  • Nguyen LP, Omoluabi O, Parra S, Frieske JM, Clement C, Ammar-Aouchiche Z, Ho SB, Ehre C, Kesimer M, Knoll BJ, Tuvim MJ, Dickey BF, Bond RA. Chronic exposure to beta-blockers attenuates inflammation and mucin content in a murine asthma model. Am J Respir Cell Mol Biol. 2008 Mar;38(3):256-62. doi: 10.1165/rcmb.2007-0279RC. Epub 2007 Dec 20.

    PMID: 18096872BACKGROUND

  • Hanania NA, Singh S, El-Wali R, Flashner M, Franklin AE, Garner WJ, Dickey BF, Parra S, Ruoss S, Shardonofsky F, O'Connor BJ, Page C, Bond RA. The safety and effects of the beta-blocker, nadolol, in mild asthma: an open-label pilot study. Pulm Pharmacol Ther. 2008;21(1):134-41. doi: 10.1016/j.pupt.2007.07.002. Epub 2007 Jul 17.

    PMID: 17703976BACKGROUND

  • Lipworth BJ, Williamson PA. Think the impossible: beta-blockers for treating asthma. Clin Sci (Lond). 2009 Oct 12;118(2):115-20. doi: 10.1042/CS20090398.

    PMID: 19807697BACKGROUND

  • Anderson WJ, Short PM, Jabbal S, Lipworth BJ. Inhaled corticosteroid dose response in asthma: Should we measure inflammation? Ann Allergy Asthma Immunol. 2017 Feb;118(2):179-185. doi: 10.1016/j.anai.2016.11.018. Epub 2017 Jan 3.

    PMID: 28065396DERIVED

  • Anderson WJ, Short PM, Williamson PA, Manoharan A, Lipworth BJ. The inverse agonist propranolol confers no corticosteroid-sparing activity in mild-to-moderate persistent asthma. Clin Sci (Lond). 2014 Dec;127(11):635-43. doi: 10.1042/CS20140249.

    PMID: 24938324DERIVED

MeSH Terms

Conditions

AsthmaRespiratory Hypersensitivity

Interventions

Propranolol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • William J Anderson, MBChB

    University of Dundee

    PRINCIPAL INVESTIGATOR

  • Brian J Lipworth, MD

    University of Dundee

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

February 24, 2012

First Posted

March 6, 2012

Study Start

April 4, 2012

Primary Completion

May 25, 2013

Study Completion

May 25, 2013

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations

GB(1)