Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma
PAW01
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
2 other identifiers
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 26, 2009
CompletedFirst Posted
Study publicly available on registry
January 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedApril 12, 2019
April 1, 2019
1.5 years
January 26, 2009
April 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Alveolar nitric oxide
16 weeks
Study Arms (2)
Fine particle steroid inhaler
EXPERIMENTALHFA-BDP plus Fluticasone/Salmeterol Combination
Coarse Particle Inhaler
ACTIVE COMPARATORFP plus Fluticasone/Salmeterol combination
Interventions
Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asthma and Allergy Research Group, Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY, United Kingdom
Related Publications (1)
Williamson PA, Short PM, Vaidyanathan S, Lipworth BJ. Inhaled and systemic corticosteroid response in severe asthma assessed by alveolar nitric oxide: a randomized crossover pilot study of add-on therapy. Br J Clin Pharmacol. 2013 Jan;75(1):93-102. doi: 10.1111/j.1365-2125.2012.04319.x.
PMID: 22568828RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter A Williamson
University of Dundee
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 26, 2009
First Posted
January 27, 2009
Study Start
January 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
April 12, 2019
Record last verified: 2019-04