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

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ClinicalTrials.gov Identifier: NCT00829257
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : April 12, 2019
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: HFA-BDP Drug: Fluticasone Drug: Seretide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Fine particle steroid inhaler
HFA-BDP plus Fluticasone/Salmeterol Combination
HFA-BDP (Qvar) 100ug 2puff b.i.d

Drug: Seretide
Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d

Active Comparator: Coarse Particle Inhaler
FP plus Fluticasone/Salmeterol combination
Drug: Fluticasone
Fluticasone propionate Accuhaler 250ug b.i.d.

Drug: Seretide
Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d

Primary Outcome Measures :
  1. Alveolar nitric oxide [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829257

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United Kingdom
Asthma and Allergy Research Group, Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
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Principal Investigator: Peter A Williamson University of Dundee
Publications of Results:
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Responsible Party: Brian J Lipworth, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT00829257    
Other Study ID Numbers: PAW01
Eudract no: 2008-001811-40 ( Registry Identifier: 2008RC10 )
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pathologic Processes
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists