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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-08-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

study drug

Group Type EXPERIMENTAL

Fluticasone propionate

Intervention Type DRUG

Study drug

Interventions

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Fluticasone propionate

Study drug

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Christchurch, , New Zealand

Site Status

GSK Investigational Site

Wellington, , New Zealand

Site Status

Countries

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New Zealand

Study Documents

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