FAST - four-fold asthma study: the clinical and cost effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations
- Conditions
- Respiratory (asthma)RespiratoryAsthma
- Registration Number
- ISRCTN15441965
- Lead Sponsor
- niversity of Nottingham (UK)
- Brief Summary
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27737713 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29504499 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30520413
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1774
1. Male or female aged 16 years and over
2. Clinician diagnosed asthma treated with a licensed dose of inhaled corticosteroid (i.e. step 2 to 4 of the British Thoracic Society [BTS] /Scottish Intercollegiate Guidelines Network [SIGN] guidelines)
3. One or more exacerbation in the last 12 months requiring treatment with systemic corticosteroids
Potential participants will be excluded on the basis of:
1. History more in keeping with smoking related chronic obstructive pulmonary disease [COPD] (smoked > 20 pack years, without evidence of significant reversibility and eosinophilia)
2. On maintenance oral steroids (i.e. step 5 BTS/SIGN guidelines)
3. Using a combination inhaler for both maintenance and relief treatment
4. Experienced an exacerbation within 4 weeks of randomisation
5. Pregnant women, lactating women or women who are planning to become pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first asthma exacerbation, defined as: the need for systemic corticosteroids and/or unscheduled health care consultation for asthma.
- Secondary Outcome Measures
Name Time Method