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.