Symbicort in mild asthma
Research type
Research Study
Full title
A 52-week, double-blind, randomised, multi-centre, parallel-group, phase III study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budesonide/formoterol) turbuhaler 160/4.5µg 'as needed' compared with terbutaline Turbuhaler 0.4mg 'as needed' and with Pulmicort (budesonide) Turbuhaler 200µg twice daily plus terbutaline Turbuhaler 0.4mg 'as needed'.
IRAS ID
153444
Contact name
Christopher Strang
Contact email
Sponsor organisation
Astrazeneca
Eudract number
2013-004474-96
Research summary
Asthma is a chronic disease in which the airways become inflamed and narrowed. Symptoms of asthma include shortness of breath, chest tightness, wheezing and coughing. Symbicort® is an established asthma medication containing two ingredients: A corticsteroid (budesonide) that reduces inflammation in the airways and a bronchodilator (formoterol) that widens the airways making breathing easier.
Despite the availability of conventional treatment regimens, many patients with milder asthma remain uncontrolled and at risk of exacerbations. Severe exacerbations in these patients represent 30-40% of all asthma exacerbations requiring emergency consultation.
Symbicort is currently approved to be used in patients with moderate to severe asthma. To investigate its effectiveness in milder asthma this study will compare:
1. Symbicort used ’as needed’ plus placebo of Pulmicort (budesonide)
2. A bronchodilater, terbuatline, used ’as needed’ plus placebo of Pulmicort
3. Terbutaline used ’as needed’ plus Pulmicort
A ’placebo’ is an inactive dummy medication which looks identical to Pulmicort (budesonide). Patients will have an equal chance of receiving one of the above three treatments. All the study medicaitons will be in Turbuhalers® from which the drugs can be inhaled.Approximately 3750 patients from 19 countries will participate. From the UK about 90 patients may take part. Males and females aged 12 years or older, diagnosed with asthma at least 6 months ago may be eligible, depending on their current asthma treatments and lung function.
There will be 8 clinic visits and a phone call over a time period of 12 months plus 4-7 weeks. At the visits patients will be asked to fill in two questionnaires about their asthma and well-being and have lung function tests. Other assessments will include physical examination (twice during the study), giving a urine sample by women for pregnancy test (at study entry), measurements of weight, height, blood pressure and heart rate.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
14/SC/0249
Date of REC Opinion
10 Jul 2014
REC opinion
Further Information Favourable Opinion