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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829257
First Posted: January 27, 2009
Last Update Posted: June 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
  Purpose
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 Intervention Phase
Asthma Drug: HFA-BDP Drug: Fluticasone Drug: Seretide Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Brian J Lipworth, University of Dundee:

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

Enrollment: 15
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fine particle steroid inhaler
HFA-BDP plus Fluticasone/Salmeterol Combination
Drug: HFA-BDP
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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


Locations
United Kingdom
Asthma and Allergy Research Group, Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Investigators
Principal Investigator: Peter A Williamson University of Dundee
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian J Lipworth, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT00829257     History of Changes
Other Study ID Numbers: PAW01
Eudract no: 2008-001811-40 ( Registry Identifier: 2008RC10 )
First Submitted: January 26, 2009
First Posted: January 27, 2009
Last Update Posted: June 12, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate 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
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids