Phase 4
N=41
NasoNeb Delivery of an Intranasal Steroid
Perennial Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01270256 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Change in Nasal Peak Inspiratory Flow (NPIF) — 36.41; 18.71 liters/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Budesonide (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Nasal Peak Inspiratory Flow (NPIF) |
36.41; 18.71 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Males and females between 18 and 55 years of age.
- History of perennial allergic rhinitis.
- Positive skin test to dust mite, dog, cat or indoor mold antigen.
- 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
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Subjects treated with systemic steroids during the previous 30 days.
- Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
- Subjects treated with oral antihistamine/decongestants during the previous seven days.
- Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
- Subjects treated with immunotherapy and are escalating their dose.
- Subjects on chronic anti-asthma medications.
- Subjects with polyps in the nose or a significantly displaced septum.
- Upper respiratory infection within 14 days prior to study start.
Data sourced from ClinicalTrials.gov (NCT01270256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.