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

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.

• Authors: Eli O Meltzer, Sudeesha Kunjibettu, Nancy Hall, Mark A Wingertzahn, Crystal Murcia, William Berger, Craig LaForce
• Journal: Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology (Ann Allergy Asthma Immunol) Vol. 98 Issue 2 Pg. 175-81 (Feb 2007) ISSN: 1081-1206 [Print] United States
• PMID: 17304887 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Allergic Agents
• Pregnenediones
• ciclesonide

Topics

• Administration, Intranasal
• Adolescent
• Adult
• Aged
• Anti-Allergic Agents (administration & dosage, adverse effects, therapeutic use)
• Child
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Pregnenediones (administration & dosage, adverse effects, therapeutic use)
• Quality of Life
• Rhinitis, Allergic, Perennial (drug therapy)
• Treatment Outcome