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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400855

Enrollment

Registered

2006-11-17

Start date

2005-01-31

Completion date

2005-08-31

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, AMP challenge

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

Interventions

DRUGFluticasone propionate

Study drug

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026