Beta Blocker Therapy in Mild to Moderate Asthmatics (ANDA1)
Recruitment status was Recruiting
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.
Drug: Qvar 50
Drug: Qvar 100
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of Any Steroid Sparing Effect of Beta Blocker Therapy on Airway Hyper-responsiveness in Stable, Mild to Moderate Asthmatics|
- 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).
- 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 ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Experimental: Propranolol + Low dose Qvar||
Propranolol: 10mg bd for 1 week, 20mg bd for 2 weeks, 80mg MR for 4 weeks.Drug: Qvar 50
Qvar 50, 1 puff bd for 6 weeks
|Active Comparator: Placebo + high dose Qvar||
Placebo tablets: 1 tab bd for 2 weeks, 1 tab od for 4 weeksDrug: Qvar 100
Qvar 100, 2 puffs bd for 6 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544634
|Contact: William J Anderson, MBChBfirstname.lastname@example.org|
|Asthma and Allergy Research Group, University of Dundee||Recruiting|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Contact: William J Anderson, MBChB 441382496440 email@example.com|
|Contact: Patricia Burns, BSc 441382496440 firstname.lastname@example.org|
|Principal Investigator: William J Anderson, MBChB|
|Principal Investigator:||William J Anderson, MBChB||University of Dundee|
|Study Director:||Brian J Lipworth, MD||University of Dundee|