Novel START (Novel Symbicort Turbuhaler Asthma Reliever Therapy)
Research type
Research Study
Full title
Randomised Controlled Trial of the efficacy and safety of an ICS/LABA reliever therapy regimen in asthma.
IRAS ID
188191
Contact name
Ian Pavord
Contact email
Sponsor organisation
Medical Research Institute of New Zealand
Eudract number
2015-002384-42
Clinicaltrials.gov Identifier
ACTRN12615000999538, ANZCTRN; U1111-1170-2118, UTN
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
We are investigating the safety and effectiveness in mild asthma of 3 treatment regimens:
1. A combination inhaled corticosteroid (ICS) and longacting beta agonist (LABA) inhaler on an as required (PRN) basis in patients with mild asthma.
2. An as required short acting beta agonist (SABA).
3. Regular inhaled corticosteroid (ICS) with a SABA inhaler used as required.
Each participant will be randomised to one of the three treatment arms (as above) for a 52 week study period. There are 7 scheduled visits in total (Visit 0 may be combined with Visit 1). The initial clinic visit involves obtaining informed consent, reviewing eligibility for inclusion, collecting medical history and baseline respiratory function, asthma questionnaires about asthma severity and medication compliance, and a blood test. All inhaler medication will be provided to participants during clinic visits along with an asthma management plan specific to their arm of treatment. Inhalers will be fitted with a usage monitoring device. Data can be downloaded at each clinic visit.
Education will be provided around inhaler technique and use. Each of the following 6 clinic visits will involve collecting data from the inhaler monitors, repeating lung function testing and the asthma questionnaires, as well as
reviewing any asthma exacerbations or other reasons to withdraw a participant from the study.
The main outcome of the study is the rate of participants’ experiencing worsening of their asthma symptoms and how frequently this happens in each of the three treatment groups. We can use these results to compare the different inhaler regimens to see if one is more effective at controlling asthma symptoms. This information will help to guide future management of patients with asthma.REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0453
Date of REC Opinion
19 Sep 2016
REC opinion
Favourable Opinion