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OpenTrials
Completed

NCT Number: NCT00400855

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

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Christchurch, New Zealand

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone propionate

Drug

Study drug

Primary outcomes

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

    Time frame: 5 days

Secondary outcomes

  1. Safety following multiple AMP challenges: Adverse events

    Time frame: 5 days

  2. Plasma concentrations of FP and derived pharmacokinetic parameters

    Time frame: 5 days

  3. Exhaled nitric oxide concentrations

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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.

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Nov 17, 2006
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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