Skip to main content
OpenTrials
Completed

NCT Number: NCT01270256

NasoNeb Delivery of an Intranasal Steroid

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Perennial Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Budesonide

Drug

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

Placebo

Drug

Placebo delivered intranasally via NasoNeb nebulizer once daily

Primary outcomes

  1. Change in Nasal Peak Inspiratory Flow (NPIF)

    Time frame: Baseline and 26 days

    NPIF was measured objectively in liters per minute with an In-Check Peak & Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • MedInvent, LLC

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 5, 2011
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.