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CompletedNCT00400855Updated Sep 15, 2016

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

A Phase 2 interventional study of Fluticasone propionate in Asthma, sponsored by GlaxoSmithKline. Completed at 2 sites in New Zealand. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-09-15.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • AMP challenge
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 49 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Arm 1

    study drug

    Drug: Fluticasone propionate

Interventions

  • DrugFluticasone propionate

    Study drug

06

What researchers measure

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

07

Study locations

2 sites
  • GSK Investigational Site
    Christchurch, 8011, New Zealand
  • GSK Investigational Site
    Wellington, 6035, New Zealand
08

References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00400855
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 17, 2006
Start date
Jan 2005
Primary completion
Aug 2005
Completion
Aug 2005
Last update
Sep 15, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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