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CompletedNCT00453778Updated Feb 12, 2013

A Study To Investigate The Effect Of Inhaled Fluticasone Propionate On The Bronchial Responsiveness To Leukotriene D4 In Asthmatics Patients

A Phase 4 interventional study of FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate) in Asthma and Mild Asthma, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-02-12.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments. Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of each treatment period and on treatment days 13 and 14 respectively.

02

Conditions studied

  • Asthma
  • Mild Asthma

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Keywords

  • mild asthma
  • FLIXOTIDE
  • methacholine
  • bronchial challenge
  • leukotriene D4
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 14 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 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed history of asthma
  • Non smoker last two years
  • \< 5 pack years
  • FEV1 >70% of predicted
  • Mild and stable asthma
  • Only using short acting b2-agonist as rescue for the last 4 weeks
  • Have a history of atopy.

Exclusion criteria

Exclusion:

  • Any significant respiratory disease, other than asthma
  • Subjects with seasonal asthma may not be included if they are in their season
  • Use of oral or inhaled glucocorticosteroid for the last 3 months and long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within two weeks
  • Upper or lower RTI within 6 weeks
  • Evidence of any disease that in the investigators mind would affect the results of the study
  • Participating in another study within 4 weeks
  • Females who are pregnant, intend to be or who are lactating
  • Methacholine PD20 > 454mcg
  • Negative scin prick test
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
14 participants

Interventions

  • DrugFLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)
06

What researchers measure

Primary outcomes

  1. LTD4 PC20

Secondary outcomes

  1. Shift in methacholine PD20

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00453778
Lead sponsor
GlaxoSmithKline
First posted
Mar 29, 2007
Start date
Nov 2002
Primary completion
May 2004
Completion
May 2004
Last update
Feb 12, 2013

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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