Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma
Information source: University of Dundee
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: HFA-BDP (Drug); Fluticasone (Drug); Seretide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Dundee Official(s) and/or principal investigator(s): Peter A Williamson, Principal Investigator, Affiliation: University of Dundee
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: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Asthma and Allergy Research Group, Ninewells Hospital and Medical School, Dundee, Scotland DD1 9SY, United Kingdom
Additional Information
Group website
Starting date: January 2009
Last updated: June 11, 2012
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