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AsthmaPhase 2ANDA1NCT01544634

Beta Blocker Therapy in Mild to Moderate Asthmatics

A Phase 2 study testing Propranolol, Qvar 50 and Qvar 100 in people with Asthma, run by University of Dundee at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
Propranolol, Qvar 50 and Qvar 100
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteUnited Kingdom
Study dates
4 Apr 2012to 25 May 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Asthma and Allergy Research Group, University of Dundee

    Dundee, Scotland, DD1 9SY

Other trials in United Kingdom

About this study

Official title: Evaluation of Any Steroid Sparing Effect of Beta Blocker Therapy on Airway Hyper-responsiveness in Stable, Mild to Moderate Asthmatics

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.

Read more

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.

Conditions
Asthma
Being tested
Propranolol, Placebo, Qvar 50, Qvar 100
Keywords
Asthma, Propranolol, Inhaled corticosteroids, Steroid sparing agent, Airway hyper-responsiveness
Medical subject headings
Asthma, Respiratory Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropranololDrug

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

  • PlaceboDrug

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

  • Qvar 50Drug

    Qvar 50, 1 puff bd for 6 weeks

  • Qvar 100Drug

    Qvar 100, 2 puffs bd for 6 weeks

Study groups in NCT01544634
Study groupRoleWhat they receive
Propranolol + Low dose QvarExperimentalNot described
Receives: Drug: Propranolol; Drug: Qvar 50
Placebo + high dose QvarActive comparatorNot described
Receives: Drug: Placebo; Drug: Qvar 100

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Change from baseline to 6 weeks

Secondary outcomes (7)

  1. Change in Impulse oscillometry parameters at 6 weeks

    Change in: Resistance at 5Hz, Resistance at 20Hz, Reactance at 5Hz, Frequency of resonance, Area under reactance curve.

    Measured: Change from baseline to 6 weeks

  2. Change in Spirometry parameters at 6 weeks

    Change in: Forced expiratory volume in 1 second (FEV1); forced vital capacity (FVC); forced expriatory flow between 25-75% of vital capacity; FEV1/FVC ratio.

    Measured: Change from baseline to 6 weeks

  3. Change in resting heart rate at 6 weeks

    Abosolute change in heart rate at 6 weeks will be a secondary outcome. Participants will measure their own heart rate at home on a daily basis and compare this to a given cut-off value, below which they will be advised to contact a trial doctor.

    Measured: Change from baseline to 6 weeks

  4. Change in resting blood pressure at 6 weeks

    Blood pressure will be monitored at each visit, or if patients develop symptoms that may be due to low blood pressure.

    Measured: Change from baseline to 6 weeks

  5. Change in exhaled tidal nitric oxide levels at 6 weeks

    Measured: Change from baseline to 6 weeks

  6. Change in overnight urinary cortisol/creatinine ratio (OUCC) at 6 weeks

    Systemic effects from inhaled corticosteroids can be measured using OUCC.

    Measured: Change from baseline to 6 weeks

  7. Change in symptom scores (Asthma control questionnaire and Asthma quality of life questionnaire) at 6 weeks

    Measured: Change from baseline to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2012 (estimated)
  2. Study start4 Apr 2012
  3. Primary completion25 May 2013
  4. Study completion25 May 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01544634
Sponsor's protocol ID
2011RC16
Other IDs
2011-002512-89
Acronym
ANDA1
Status last verified
Mar 2018
First submitted
24 Feb 2012
Last updated
30 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21459857

  • 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.

    PubMed 17689122

  • 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.

    PubMed 18096872

  • 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.

    PubMed 17703976

  • 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.

    PubMed 19807697

  • 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.

    PubMed 28065396

  • 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.

    PubMed 24938324

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol, Qvar 50 and Qvar 100 in people with Asthma, run by University of Dundee at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Histamine provocative concentration causing 20% fall in FEV1 (PC20)at 6 weeks (time frame: Change from baseline to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01544634, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.

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Beta Blocker Therapy in Mild to Moderate Asthmatics | AzTrials