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

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Novartis

Status

Completed

Conditions

Allergic Rhinitis

Treatments

Drug: Dust mite extract, Fluticasone, Methacholine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00513487
CPJMR0052107

Details and patient eligibility

About

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.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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