Effects of Multiple Nasal Exposures to House Dust Mite Allergen on Nasal and Body Inflammation and Airway Sensitivity
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.
Official Title
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
Conditions
Allergic Rhinitis
Study Type
Interventional
Study Design
Randomized, Open Label, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Further Details
Primary Outcome Measures:
- Total nasal symptom score recorded at baseline, and at pre-challenge,15 mins, 30 mins,and at 1,2,3,4,8 hours
Secondary Outcome Measures:
- 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
Study Start
July 2007
Eligibility & Criteria
- Ages Eligible for Study: 18 Years – 55 Years
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers
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/exclusion criteria may apply.
Total Enrolment
18
Contact Details
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513487
Contact: Novartis Investigative site, Sydney, Australia
Phone: +41 61 324 1111
Website: ClinicalTrials.gov
Dates
Tags
Created by: