NasoNeb Delivery of an Intranasal Steroid

Overview

The purpose of this study is to see if a nasal steroid drug delivered to the nose with the NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round allergy symptoms).

Full Title of Study: “Evaluation of NasoNeb™ Delivery of an Intranasal Steroid in the Treatment of Perennial Allergic Rhinitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2012

Interventions

  • Drug: Budesonide
    • Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
  • Drug: Placebo
    • Placebo delivered intranasally via NasoNeb nebulizer once daily

Arms, Groups and Cohorts

  • Active Comparator: Budesonide
    • Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
  • Placebo Comparator: Placebo
    • Placebo delivered intranasally via NasoNeb nebulizer once daily

Clinical Trial Outcome Measures

Primary Measures

  • Change in Nasal Peak Inspiratory Flow (NPIF)
    • Time Frame: Baseline and 26 days
    • NPIF was measured objectively in liters per minute with an In-Check Peak & Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated

Participating in This Clinical Trial

Inclusion Criteria 1. Males and females between 18 and 55 years of age. 2. History of perennial allergic rhinitis. 3. Positive skin test to dust mite, dog, cat or indoor mold antigen. 4. And a combined nasal AM and PM score of ≥4 for nasal congestion in the day preceding entry and total nasal symptom score greater than 8. Exclusion Criteria 1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. Pregnant or lactating women. 3. Subjects treated with systemic steroids during the previous 30 days. 4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days. 5. Subjects treated with oral antihistamine/decongestants during the previous seven days. 6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days. 7. Subjects treated with immunotherapy and are escalating their dose. 8. Subjects on chronic anti-asthma medications. 9. Subjects with polyps in the nose or a significantly displaced septum. 10. Upper respiratory infection within 14 days prior to study start.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Chicago
  • Collaborator
    • MedInvent, LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert M Naclerio, MD, Principal Investigator, University of Chicago

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