Overview

Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma

Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Dundee
Treatments:
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Fluticasone-Salmeterol Drug Combination
Salmeterol Xinafoate
Criteria
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.