Back to resultsAdditive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma (PAW01)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
HFA-BDP
Fluticasone
Seretide
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility 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.
Sites / Locations
- Asthma and Allergy Research Group, Ninewells Hospital and Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fine particle steroid inhaler
Coarse Particle Inhaler
Arm Description
HFA-BDP plus Fluticasone/Salmeterol Combination
FP plus Fluticasone/Salmeterol combination
Outcomes
Primary Outcome Measures
Alveolar nitric oxide
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00829257
Brief Title
Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma
Acronym
PAW01
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 Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fine particle steroid inhaler
Arm Type
Experimental
Arm Description
HFA-BDP plus Fluticasone/Salmeterol Combination
Arm Title
Coarse Particle Inhaler
Arm Type
Active Comparator
Arm Description
FP plus Fluticasone/Salmeterol combination
Intervention Type
Drug
Intervention Name(s)
HFA-BDP
Intervention Description
HFA-BDP (Qvar) 100ug 2puff b.i.d
Intervention Type
Drug
Intervention Name(s)
Fluticasone
Intervention Description
Fluticasone propionate Accuhaler 250ug b.i.d.
Intervention Type
Drug
Intervention Name(s)
Seretide
Intervention Description
Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d
Primary Outcome Measure Information:
Title
Alveolar nitric oxide
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Williamson
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asthma and Allergy Research Group, Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22568828
Citation
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.
Results Reference
result
Learn more about this trial
Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma
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