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 - Full Text View

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 (PAW01)

This study is currently recruiting participants.

Verified by University of Dundee, January 2009

First Received: January 26, 2009 No Changes Posted

Sponsored by:	University of Dundee
Information provided by:	University of Dundee
ClinicalTrials.gov Identifier:	NCT00829257

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment
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:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Advair Beclomethasone Beclomethasone dipropionate

U.S. FDA Resources

Further study details as provided by University of Dundee:

Primary Outcome Measures:

Alveolar nitric oxide [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fine particle steroid inhaler: Experimental 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
Coarse Particle Inhaler: Active Comparator 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

Contacts

Contact: Peter A Williamson	+44 (0) 1382 496440	P.A.Williamson@dundee.ac.uk
Contact: Karine Clearie	+44 (0) 1382 496440	K.Clearie@dundee.ac.uk

Locations

United Kingdom, Scotland
Asthma and Allergy Research Group, Ninewells Hospital and Medical School	Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Contact: Peter A Williamson +44 (0)1382 496440
Principal Investigator: Peter A Williamson

Sponsors and Collaborators

University of Dundee

Investigators

Principal Investigator:

Peter A Williamson

University of Dundee

More Information

Additional Information:

Group website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Dundee ( Principle Investigator: Peter A Williamson )
Study ID Numbers:	PAW01, Eudract no: 2008-001811-40
Study First Received:	January 26, 2009
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00829257 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Salmeterol
Adrenergic beta-Agonists
Adrenergic Agents
Bronchial Diseases
Albuterol
Anti-Asthmatic Agents
Asthma
Beclomethasone
Anti-Allergic Agents

Adrenergic Agonists
Inflammation
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Pathologic Processes
Tocolytic Agents
Respiratory Tract Diseases

Therapeutic Uses
Fluticasone
Dermatologic Agents
Salmeterol
Immune System Diseases
Adrenergic beta-Agonists
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Inflammation
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009