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

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

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
Drug: Fluticasone
Drug: Seretide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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 University of Dundee:

Primary Outcome Measures:
  • Alveolar nitric oxide [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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
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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00829257

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

Additional Information:
No publications provided

Responsible Party: Brian J Lipworth, Professor, University of Dundee Identifier: NCT00829257     History of Changes
Other Study ID Numbers: PAW01, Eudract no: 2008-001811-40
Study First Received: January 26, 2009
Last Updated: June 11, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pathologic Processes
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents processed this record on April 17, 2014