Phase 4 Completed N=41 Randomized Quadruple-blind Treatment

NasoNeb Delivery of an Intranasal Steroid

Perennial Allergic Rhinitis

Source: ClinicalTrials.gov NCT01270256 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcomePrimary: Change in Nasal Peak Inspiratory Flow (NPIF) — 36.41; 18.71 liters/min

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Nasal Peak Inspiratory Flow (NPIF)	36.41; 18.71	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.