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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513487
• Other study ID #: CPJMR0052107
• Status: Completed
• Phase: N/A
• First received: August 6, 2007
• Last updated: July 14, 2008
• Start date: July 2007
• Est. completion date: November 2007

Study information

• Verified date: July 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Allergic Rhinitis
• Inflammation
• Rhinitis

Intervention

Drug:
• Dust mite extract, Fluticasone, Methacholine
Dust mite extract, Fluticasone, Methacholine

Locations

Country	Name	City	State
Australia	Novartis Investigative site	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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