NasoNeb Delivery of an Intranasal Steroid

The University of Chicago

Status and phase: Completed; Phase 4

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: Placebo; Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT01270256

10-660-B

Details and patient eligibility

About

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).

Enrollment: 41 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups, including a placebo group

Budesonide

Active Comparator group

Description:

Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily

Treatment:

Drug: Budesonide

Placebo

Placebo Comparator group

Description:

Placebo delivered intranasally via NasoNeb nebulizer once daily

Treatment:

Drug: Placebo