A Proof of Concept Study to Evaluate the Additive Effects of HFA-BDP (Qvar) to Fluticasone/Salmeterol (Seretide) on Surrogate Markers of Small and Large Airway Inflammation in Refractory Asthma
Information source: University of Dundee
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: HFA-BDP (Drug); Fluticasone (Drug); Seretide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Dundee Official(s) and/or principal investigator(s):
Peter A Williamson, Principal Investigator, Affiliation: University of Dundee
Overall contact:
Peter A Williamson, Phone: +44 (0) 1382 496440, Email: P.A.Williamson@dundee.ac.uk
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.
Clinical Details
Official title: A Proof of Concept Study to Evaluate the Additive Effects of HFA-BDP (Qvar) to Fluticasone/Salmeterol (Seretide) on Surrogate Markers of Small and Large Airway Inflammation in Refractory Asthma
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment
Primary outcome: Alveolar nitric oxide
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Peter A Williamson, Phone: +44 (0) 1382 496440, Email: P.A.Williamson@dundee.ac.uk
Asthma and Allergy Research Group, Ninewells Hospital and Medical School, Dundee, Scotland DD1 9SY, United Kingdom; Recruiting
Peter A Williamson, Phone: +44 (0)1382 496440
Peter A Williamson, Principal Investigator
Additional Information
Group website
Starting date: January 2009
Ending date: January 2010
Last updated: January 26, 2009
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