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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Asthma

Treatments

Drug: Fluticasone propionate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00400855

SIG103337

Details and patient eligibility

About

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.

Full 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

Enrollment

49 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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