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NCT00829257 Clinical Trial

Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma

Asthma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00829257
Other study ID # PAW01
Secondary ID Eudract no: 2008
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2009
Est. completion date July 2010

Study information
Verified date April 2019
Source University of Dundee
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HFA-BDP
HFA-BDP (Qvar) 100ug 2puff b.i.d
• Fluticasone
Fluticasone propionate Accuhaler 250ug b.i.d.
• Seretide
Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d

Locations
Country Name City State
United Kingdom Asthma and Allergy Research Group, Ninewells Hospital and Medical School Dundee Scotland

Sponsors (1)
Lead Sponsor Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

References & 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: 1 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Alveolar nitric oxide 16 weeks
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