NasoNeb Delivery of an Intranasal Steroid

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
Evaluation of NasoNeb™ Delivery of an Intranasal Steroid in the Treatment of Perennial Allergic Rhinitis

Conditions
-----------------
Perennial Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Budesonide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Males and females between 18 and 55 years of age. History of perennial allergic rhinitis. Positive skin test to dust mite, dog, cat or indoor mold antigen. 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 Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. Pregnant or lactating women. Subjects treated with systemic steroids during the previous 30 days. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days. Subjects treated with oral antihistamine/decongestants during the previous seven days. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days. Subjects treated with immunotherapy and are escalating their dose. Subjects on chronic anti-asthma medications. Subjects with polyps in the nose or a significantly displaced septum. Upper respiratory infection within 14 days prior to study start.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Budesonide<br>Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily | Drug: Budesonide<br>* Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily<br>|
| Placebo Comparator: Placebo<br>Placebo delivered intranasally via NasoNeb nebulizer once daily | Drug: Placebo<br>* Placebo delivered intranasally via NasoNeb nebulizer once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nasal Peak Inspiratory Flow (NPIF) | 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 | Baseline and 26 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergy