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

Assessment of the Effects of Multiple Nasal Antigen Challenges With Dust Mite Allergen on Local and Systemic Allergic Inflammation and Bronchoreactivity in Subjects With Allergic Rhinitis Sensitive to House Dust Mite - a Feasibility and Site Evaluation Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00513487

Enrollment

Registered

2007-08-08

Start date

2007-07-31

Completion date

2007-11-30

Last updated

2008-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis, dust mites, IgE, IL-13, nasal, inflammation

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.

Interventions

DRUGDust mite extract, Fluticasone, Methacholine

Dust mite extract, Fluticasone, Methacholine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026