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Effects of Multiple Nasal Exposures to House Dust Mite Allergen on Nasal and Body Inflammation and Airway Sensitivity

NCT ID: NCT00513487

Last Updated: 2008-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Rhinitis

Keywords

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Allergic Rhinitis dust mites IgE IL-13 nasal inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Dust mite extract, Fluticasone, Methacholine

Dust mite extract, Fluticasone, Methacholine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigative site

Locations

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Novartis Investigative site

Sydney, , Australia

Site Status

Countries

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Australia

Other Identifiers

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CPJMR0052107

Identifier Type: -

Identifier Source: org_study_id