NCT00513487

Brief Summary

This study will evaluate whether multiple nasal antigen challenges with dust mite allergen produces increases in nasal symptoms and local allergic inflammatory cells in the nose and the blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

July 15, 2008

Status Verified

July 1, 2008

First QC Date

August 6, 2007

Last Update Submit

July 14, 2008

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitisdust mitesIgEIL-13nasalinflammation

Outcome Measures

Primary Outcomes (1)

  • Total nasal symptom score recorded at baseline, and at pre-challenge,15 mins, 30 mins,and at 1,2,3,4,8 hours

    throughout the study

Secondary Outcomes (1)

  • Peak nasal inspiratory flow at time points of total nasal symptom score. Mechanistic markers during challenge days. Exhaled nitric oxide,forced expiratory vol in 1 second & airway resistance at baseline, first & last day

    throughout the study

Interventions

Dust mite extract, Fluticasone, MethacholineDRUG

Dust mite extract, Fluticasone, Methacholine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy non-smoking subjects with a history of allergic rhinitis consistent with dust mite allergy showing
  • A positive skin prick test to dust mite at or within the 12 months before study start
  • Demonstrate symptomatic worsening after graded nasal allergen challenge

You may not qualify if:

  • Subjects found to be very sensitive to house dust mites (if the skin prick test produces a wheal of mean with a diameter greater than 11 mm).
  • Presence of any respiratory disease other than a history of mild stable asthma not requiring regular treatment.
  • Any known contraindications for methacholine challenge testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative site

Sydney, Australia

Location

MeSH Terms

Conditions

Rhinitis, AllergicInflammation

Interventions

FluticasoneMethacholine Chloride

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMethacholine CompoundsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Novartis

    Investigative site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 8, 2007

Study Start

July 1, 2007

Study Completion

November 1, 2007

Last Updated

July 15, 2008

Record last verified: 2008-07

Locations

AU(1)