NasoNeb Delivery of an Intranasal Steroid

Phase 4

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: Budesonide; Drug: Placebo

• Registration Number: NCT01270256
• Lead Sponsor: University of Chicago

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-05
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Results First Submitted: 2014-06-16
• Results First Submitted QC: 2014-06-16
• Status Verified: 2014-07
• Results First Posted: 2014-07-16
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budesonide	Budesonide	Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
Placebo	Placebo	Placebo delivered intranasally via NasoNeb nebulizer once daily

Primary Outcome Measures

Name	Time	Method
Change in Nasal Peak Inspiratory Flow (NPIF)	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

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States