Text Size

Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma (PAW01)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
ClinicalTrials.gov Identifier:
NCT00829257
First received: January 26, 2009
Last updated: June 11, 2012
Last verified: June 2012
History of Changes

January 26, 2009
June 11, 2012
January 2009
July 2010   (final data collection date for primary outcome measure)
Alveolar nitric oxide [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00829257 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Drug: HFA-BDP
    HFA-BDP (Qvar) 100ug 2puff b.i.d
  • Drug: Fluticasone
    Fluticasone propionate Accuhaler 250ug b.i.d.
  • Drug: Seretide
    Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d
  • Experimental: Fine particle steroid inhaler
    HFA-BDP plus Fluticasone/Salmeterol Combination
    Interventions:
    • Drug: HFA-BDP
    • Drug: Seretide
  • Active Comparator: Coarse Particle Inhaler
    FP plus Fluticasone/Salmeterol combination
    Interventions:
    • Drug: Fluticasone
    • Drug: Seretide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00829257
PAW01, Eudract no: 2008-001811-40
Yes
Brian J Lipworth, University of Dundee
University of Dundee
Not Provided
Principal Investigator: Peter A Williamson University of Dundee
University of Dundee
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP