NasoNeb Delivery of an Intranasal Steroid

This study has been completed.
MedInvent, LLC
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: January 3, 2011
Last updated: July 17, 2014
Last verified: July 2014

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).

Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: Budesonide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of NasoNeb™ Delivery of an Intranasal Steroid in the Treatment of Perennial Allergic Rhinitis

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Change in Nasal Peak Inspiratory Flow (NPIF) [ Time Frame: Baseline and 26 days ] [ Designated as safety issue: No ]
    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

Enrollment: 41
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Budesonide
Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
Drug: 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
Drug: Placebo
Placebo delivered intranasally via NasoNeb nebulizer once daily


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01270256

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
MedInvent, LLC
Principal Investigator: Robert M Naclerio, MD University of Chicago
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Chicago Identifier: NCT01270256     History of Changes
Other Study ID Numbers: 10-660-B
Study First Received: January 3, 2011
Results First Received: June 16, 2014
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:

Additional relevant MeSH terms:
Rhinitis, Allergic, Perennial
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on October 08, 2015