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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Fluticasone propionate

• Registration Number: NCT00400855
• Lead Sponsor: GlaxoSmithKline

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 Timeline

• Study Start: 2005-01
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2006-11-15
• Study First Submitted QC: 2006-11-15
• Study First Posted: 2006-11-17
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Fluticasone propionate	study drug

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety following multiple AMP challenges: Adverse events	5 days
Plasma concentrations of FP and derived pharmacokinetic parameters	5 days
Exhaled nitric oxide concentrations	5 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇿 Wellington, New Zealand