Expired Study
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Chicago, Illinois 60637


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).


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.


Study is Available At:


Original ID:

10-660-B


NCT ID:

NCT01270256


Secondary ID:


Study Acronym:


Brief Title:

NasoNeb Delivery of an Intranasal Steroid


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Chicago


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Robert M Naclerio, MD
Principal Investigator
University of Chicago

Study Dates

Start Date:January 2011
Completion Date:November 2012
Completion Type:Anticipated
Primary Completion Date:July 2012
Primary Completion Type:Actual
Verification Date:August 2012
Last Changed Date:August 14, 2012
First Received Date:January 3, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Daily change in Nasal Peak Inspiratory Flow (NPIF)
Time Frame:4 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Budesonide
Description:Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
Arm Name:Budesonide
Intervention Type:Drug
Name:Placebo
Description:Placebo delivered intranasally via NasoNeb nebulizer once daily
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo delivered intranasally via NasoNeb nebulizer once daily
Study Arm Type:Active Comparator
Arm Name:Budesonide
Description:Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago
Agency Class:Other
Agency Type:Collaborator
Agency Name:MedInvent, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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