Are you a Health Professional? Jump over to the doctors only platform. Click Here

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

Print Friendly, PDF & Email

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


Print Friendly, PDF & Email

Dates

Posted On: 1 January, 2013
Modified On: 16 September, 2014

Tags



Created by: myVMC