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

Tracking Information

First Received Date ^ICMJE

November 15, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00400855 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

See Detailed Description

Brief Summary

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.

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Fluticasone propionate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

New Zealand

Administrative Information

NCT ID ^ICMJE

NCT00400855

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

SIG103337

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP