Efficacy and safety of ciclesonide, 200 microg once daily, for the treatment of perennial allergic rhinitis.

Full Abstract

BACKGROUND:
Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis (AR).

OBJECTIVE:
To evaluate the efficacy, safety, and quality-of-life benefits of intranasal ciclesonide, 200 microg once daily, for the treatment of perennial AR (PAR).

METHODS:
In this multicenter, randomized, double-blind, placebo-controlled study, adults and adolescents with at least a 2-year history of PAR received intranasal ciclesonide, 200 microg, or placebo once daily for 6 weeks. Patient-evaluated total nasal symptom scores (TNSSs), physician-assessed overall nasal signs and symptoms severity scores, and Rhinoconjunctivitis Quality of Life Questionnaire scores were evaluated.

RESULTS:
Patient baseline characteristics were similar in the ciclesonide (n = 238) and placebo (n = 233) groups and were consistent with moderate PAR severity. Ciclesonide therapy significantly reduced average morning and evening reflective TNSSs compared with placebo (P < .001) and significantly reduced average morning and evening instantaneous TNSSs (P = .001) over 6 weeks of treatment. At the end point, a greater decrease from baseline was observed in physician-assessed overall nasal signs and symptoms severity for the ciclesonide group compared with the placebo group (P = .051). An appreciable improvement in combined Rhinoconjunctivitis Quality of Life Questionnaire scores at the end point was also observed in the ciclesonide group (P = .01 vs placebo). The frequency of adverse events was similar between treatment groups.

CONCLUSIONS:
In this study, intranasal ciclesonide treatment was associated with significant reductions in nasal symptoms and appreciable improvements in health-related quality of life in adult and adolescent patients with PAR. Ciclesonide was well tolerated, with a safety profile comparable with that of placebo.

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Author information

Author/s: Meltzer, Eli O (EO); Kunjibettu, Sudeesha (S); Hall, Nancy (N); Wingertzahn, Mark A (MA); Murcia, Crystal (C); Berger, William (W); LaForce, Craig (C);

Affiliation: Allergy and Asthma Medical Group and Research Center, San Diego, California 92123-2661, USA. eomeltzer(-atsign-)aol.com

Journal and publication information

Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology (Ann Allergy Asthma Immunol), published in United States. (Language: eng)

Reference: 2007-Feb; vol 98 (issue 2) : pp 175-81

Dates: Created 2007/02/19; Completed 2007/03/13;

PMID: 17304887, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Administration, Intranasal
Adolescent
Adult
Aged
Anti-Allergic Agents - administration & dosage; adverse effects; therapeutic use
Child
Double-Blind Method
Female

Female
Humans
Male
Middle Aged
Pregnenediones - administration & dosage; adverse effects; therapeutic use
Quality of Life
Rhinitis, Allergic, Perennial - drug therapy
Treatment Outcome

Associated Chemicals: Anti-Allergic Agents (0) ; Pregnenediones (0) ; ciclesonide (141845-82-1)

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