Evaluation of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol, 80 or 160 μg once daily, for the treatment of seasonal allergic rhinitis.

Abstract

BACKGROUND:

A hypotonic aqueous nasal spray of ciclesonide is indicated for the treatment of allergic rhinitis (AR). A new nasal aerosol formulation of ciclesonide containing a hydrofluoroalkane propellant delivered via a metered-dose inhaler (CIC-HFA) is currently in clinical development as a potential treatment for AR.

OBJECTIVES:

To study the efficacy and safety of once-daily administration of CIC-HFA 80 or 160 μg compared with placebo in subjects 12 years and older with seasonal AR (SAR).

METHODS:

Subjects 12 years and older with a ≥ 2-year history of SAR were randomized in a placebo-controlled, double-blind, parallel-group, multicenter study to receive CIC-HFA 80 or 160 μg or placebo once daily in the morning for 2 weeks. Changes from baseline in reflective total nasal symptom scores (rTNSSs), instantaneous TNSSs (iTNSSs), and reflective total ocular symptom scores (rTOSSs) in subjects with a baseline rTOSS of ≥ 5.00 were evaluated. Treatment-emergent adverse events were monitored throughout the study.

RESULTS:

Seven hundred seven subjects were randomized. From baseline, CIC-HFA 80 or 160 μg demonstrated 15.1% and 16.0% reductions in rTNSSs (P < .0001, 3.7% for placebo), 14.3% and 15.4% reductions in iTNSSs (P < .0001, 3.9% for placebo), and 15.7% and 15.0% reductions in rTOSSs (P < .001, 6.8% for placebo). The overall incidence of treatment-emergent adverse events was low and comparable between the CIC-HFA and placebo groups.

CONCLUSIONS:

In this study, once-daily treatment with CIC-HFA 80 or 160 μg demonstrated statistically significant improvements in nasal and ocular symptoms of SAR. Both doses of active treatment were well tolerated.

• Authors: Paul Ratner, Robert Jacobs, Dale Mohar, Holly Huang, Shailesh Y Desai, Joseph Hinkle
• Journal: Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology (Ann Allergy Asthma Immunol) Vol. 105 Issue 6 Pg. 471-9 (Dec 2010) ISSN: 1534-4436 [Electronic] United States
• PMID: 21130386 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Aerosol Propellants
• Anti-Allergic Agents
• Hydrocarbons, Fluorinated
• Nasal Sprays
• Pregnenediones
• apaflurane
• ciclesonide

Topics

• Administration, Intranasal
• Adolescent
• Adult
• Aerosol Propellants (administration & dosage)
• Aged
• Anti-Allergic Agents (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Compounding
• Female
• Humans
• Hydrocarbons, Fluorinated (administration & dosage)
• Male
• Middle Aged
• Nasal Sprays
• Pregnenediones (administration & dosage, adverse effects)
• Rhinitis, Allergic, Seasonal (drug therapy)
• Treatment Outcome
• United States