Repeat Nasal Allergen Challenge

NCT ID: NCT00290368

Last Updated: 2023-09-14

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

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-05-31

Brief Summary

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This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

Detailed Description

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This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

Conditions

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Hayfever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Skin Prick Test

Intervention Type PROCEDURE

Nasal allergen challenge

Intervention Type PROCEDURE

Nasal filter paper placement

Intervention Type PROCEDURE

Nasal lavage

Intervention Type PROCEDURE

Nasal scrape

Intervention Type PROCEDURE

Nasal symptoms score

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Male and female subjects with a history of seasonal (intermittent) atopic rhinitis, aged 18-40 years.
2. Otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies.

Exclusion Criteria

1. Smokers (use of tobacco products in the previous 3 months).
2. Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (FEV1 \> 80% predicted at screening).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Principal Investigators

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Trevor T Hansel, FRCPath

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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National Heart & Lung Institute Clinical Studies Unit

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CPJMR0052104

Identifier Type: -

Identifier Source: org_study_id

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