NCT00453778

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Nov 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

1.5 years

First QC Date

March 27, 2007

Last Update Submit

February 11, 2013

Conditions

AsthmaMild Asthma

Keywords

mild asthmaFLIXOTIDEmethacholinebronchial challengeleukotriene D4

Outcome Measures

Primary Outcomes (1)

  • LTD4 PC20

Secondary Outcomes (1)

  • Shift in methacholine PD20

Interventions

FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2007

First Posted

March 29, 2007

Study Start

November 1, 2002

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

February 12, 2013

Record last verified: 2013-02