NasoNeb Delivery of an Intranasal Steroid

Perennial Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270256
• Other study ID #: 10-660-B
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2011
• Last updated: July 17, 2014
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: July 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	MedInvent, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No