NasoNeb Delivery of an Intranasal Steroid

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
MedInvent, LLC
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier:
NCT01270256
First received: January 3, 2011
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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:
  • Daily change in Nasal Peak Inspiratory Flow (NPIF) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: November 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

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270256

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

No publications provided

Responsible Party: Robert Naclerio, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT01270256     History of Changes
Other Study ID Numbers: 10-660-B
Study First Received: January 3, 2011
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
allergy

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

ClinicalTrials.gov processed this record on April 15, 2014