Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma
- Registration Number
- NCT00829257
- Lead Sponsor
- University of Dundee
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fine particle steroid inhaler HFA-BDP HFA-BDP plus Fluticasone/Salmeterol Combination Fine particle steroid inhaler Seretide HFA-BDP plus Fluticasone/Salmeterol Combination Coarse Particle Inhaler Seretide FP plus Fluticasone/Salmeterol combination Coarse Particle Inhaler Fluticasone FP plus Fluticasone/Salmeterol combination
- Primary Outcome Measures
Name Time Method Alveolar nitric oxide 16 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asthma and Allergy Research Group, Ninewells Hospital and Medical School
🇬🇧Dundee, Scotland, United Kingdom