Asthma
Conditions
Brief summary
The purpose of this study is to establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.
Interventions
Sponsors
University of Dundee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Refractory, non-smoking asthmatics with FEV1 les than 80% predicted * RV greater than 100% predicted and CANO greater than 3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication. * Informed consent and ability to perform exhaled nitric oxide assessment. * Participants must be on greater than 500mcg of fluticasone per day to enter dose ramp run-in.
Exclusion criteria
* Recent respiratory infection or oral steroid use. * Pregnancy or lactation. * Known or suspected contra-indication to any of the IMP's. * CANO less than 3ppb, FEV1 greater than 80% or RV less than 100% at post-optimisation visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alveolar nitric oxide | 16 weeks |
Countries
United Kingdom
Outcome results
None listed