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
  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: 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
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

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
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:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Salmeterol
Albuterol
Fluticasone
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

ClinicalTrials.gov processed this record on April 17, 2014