NCT00290368

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

First QC Date

February 10, 2006

Last Update Submit

September 13, 2023

Conditions

Hayfever

Keywords

Nasal allergen challengeAllergic rhinitisTimothy grass polleninflammatory mediators

Interventions

Skin Prick TestPROCEDURE
Nasal allergen challengePROCEDURE
Nasal filter paper placementPROCEDURE
Nasal lavagePROCEDURE
Nasal scrapePROCEDURE
Nasal symptoms scorePROCEDURE

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Smokers (use of tobacco products in the previous 3 months).
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart & Lung Institute Clinical Studies Unit

London, SW3 6HP, United Kingdom

Location

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitis, Allergic

Interventions

Patch TestsNasal Lavage

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesTherapeutic Irrigation

Study Officials

  • Trevor T Hansel, FRCPath

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

February 1, 2006

Study Completion

May 1, 2006

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

GB(1)