Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate

This study has been completed.

First Received: November 15, 2006 Last Updated: May 15, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00400855

Purpose

Inhaling AMP causes an inflammatory response in the lung. This study will investigate whether 5-days of treatment with fluticasone propionate protects the lung from responding to the AMP in this way.

Condition	Intervention	Phase
Asthma	Drug: Fluticasone propionate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To characterise the dose response curve following repeat inhaled doses of FP for 5 days in the AMP challenge model.

Secondary Outcome Measures:

Safety following multiple AMP challenges: Adverse events
Plasma concentrations of FP and derived pharmacokinetic parameters
Exhaled nitric oxide concentrations

Estimated Enrollment:	49
Study Start Date:	January 2005

Detailed Description:

A randomised, double-blind, placebo-controlled, incomplete block, 4-period crossover study to investigate the effects of 5-day repeat inhaled doses of fluticasone propionate (BID, 50-2000 mcg) on airway responsiveness to adenosine-5'-monophosphate (AMP) challenge when delivered after the last dose in mild asthmatic subjects

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female of non-childbearing potential
Using appropriate contraception.
Mild asthmatic, non (or ex) smokers.
Has inflammatory response to AMP.
Otherwise healthy, not using any steroids.

Exclusion Criteria:

Have a history of life-threatening asthma, defined as an asthma episode, which required intubation and/or was associated with either hypercapnea, respiratory arrest or hypoxia seizures.
Have a known sensitivity to corticosteroids.
Have a history of milk protein allergy.
Test positive at the screening visit for hepatitis B or C or HIV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400855

Locations

New Zealand
GSK Investigational Site
Christchurch, New Zealand, 8011
GSK Investigational Site
Wellington 6004, New Zealand, 6004

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SIG103337
Study First Received:	November 15, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00400855 History of Changes
Health Authority:	New Zealand: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Asthma
AMP challenge

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009