Asthma
Conditions
Keywords
Asthma, Propranolol, Inhaled corticosteroids, Steroid sparing agent, Airway hyper-responsiveness
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.
Interventions
DRUGPropranolol
Propranolol: 10mg bd for 1 week, 20mg bd for 2 weeks, 80mg MR for 4 weeks.
DRUGPlacebo
Placebo tablets: 1 tab bd for 2 weeks, 1 tab od for 4 weeks
DRUGQvar 50
Qvar 50, 1 puff bd for 6 weeks
DRUGQvar 100
Qvar 100, 2 puffs bd for 6 weeks
Sponsors
Chief Scientist Office of the Scottish Government
University of Dundee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Histamine provocative concentration causing 20% fall in FEV1 (PC20)at 6 weeks | Change from baseline to 6 weeks | Measurement of airway hyper-reactivity (a hallmark of asthma). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Spirometry parameters at 6 weeks | Change from baseline to 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. |
| Change in resting heart rate at 6 weeks | Change from baseline to 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. |
| Change in resting blood pressure at 6 weeks | Change from baseline to 6 weeks | Blood pressure will be monitored at each visit, or if patients develop symptoms that may be due to low blood pressure. |
| Change in Impulse oscillometry parameters at 6 weeks | Change from baseline to 6 weeks | Change in: Resistance at 5Hz, Resistance at 20Hz, Reactance at 5Hz, Frequency of resonance, Area under reactance curve. |
| Change in overnight urinary cortisol/creatinine ratio (OUCC) at 6 weeks | Change from baseline to 6 weeks | 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 | Change from baseline to 6 weeks | — |
| Change in exhaled tidal nitric oxide levels at 6 weeks | Change from baseline to 6 weeks | — |
Countries
United Kingdom
Outcome results
None listed