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Beta Blocker Therapy in Mild to Moderate Asthmatics (ANDA1)

This study is currently recruiting participants.
Verified June 2012 by University of Dundee
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
William J Anderson, University of Dundee
ClinicalTrials.gov Identifier:
NCT01544634
First received: February 24, 2012
Last updated: June 11, 2012
Last verified: June 2012
History of Changes

February 24, 2012
June 11, 2012
March 2012
August 2013   (final data collection date for 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 ] [ Designated as safety issue: No ]
Measurement of airway hyper-reactivity (a hallmark of asthma).
Same as current
Complete list of historical versions of study NCT01544634 on ClinicalTrials.gov Archive Site
  • Change in Impulse oscillometry parameters at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
    Change in: Resistance at 5Hz, Resistance at 20Hz, Reactance at 5Hz, Frequency of resonance, Area under reactance curve.
  • Change in Spirometry parameters at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
    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.
  • Change in resting heart rate at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: Yes ]
    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.
  • Change in resting blood pressure at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: Yes ]
    Blood pressure will be monitored at each visit, or if patients develop symptoms that may be due to low blood pressure.
  • Change in exhaled tidal nitric oxide levels at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Change in overnight urinary cortisol/creatinine ratio (OUCC) at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: Yes ]
    Systemic effects from inhaled corticosteroids can be measured using OUCC.
  • Change in symptom scores (Asthma control questionnaire and Asthma quality of life questionnaire) at 6 weeks [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Beta Blocker Therapy in Mild to Moderate Asthmatics
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.

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Propranolol
    Propranolol: 10mg bd for 1 week, 20mg bd for 2 weeks, 80mg MR for 4 weeks.
  • Drug: Placebo
    Placebo tablets: 1 tab bd for 2 weeks, 1 tab od for 4 weeks
  • Drug: Qvar 50
    Qvar 50, 1 puff bd for 6 weeks
  • Drug: Qvar 100
    Qvar 100, 2 puffs bd for 6 weeks
  • Experimental: Propranolol + Low dose Qvar
    Interventions:
    • Drug: Propranolol
    • Drug: Qvar 50
  • Active Comparator: Placebo + high dose Qvar
    Interventions:
    • Drug: Placebo
    • Drug: Qvar 100

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 65 Years
No
Contact: William J Anderson, MBChB 00441382496440 w.j.anderson@dundee.ac.uk
United Kingdom
 
NCT01544634
2011RC16, 2011-002512-89
No
William J Anderson, University of Dundee
University of Dundee
Chief Scientist Office of the Scottish Government
Principal Investigator: William J Anderson, MBChB University of Dundee
Study Director: Brian J Lipworth, MD University of Dundee
University of Dundee
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP