A 26-week tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis.

Abstract

BACKGROUND:

A new, hydrofluoroalkane nasal aerosol solution formulation of ciclesonide (CIC-HFA) delivered via a metered dose inhaler is currently in clinical development for treatment of allergic rhinitis.

OBJECTIVE:

To study tolerability and quality of life following administration of CIC-HFA 74- or 148-μg doses once-daily compared with placebo in patients with perennial allergic rhinitis (PAR) over 26 weeks.

METHODS:

Patients ≥12 years of age with a ≥2 year history of PAR were randomized in a placebo-controlled, double-blind, parallel group, multicenter study to CIC-HFA 74 μg, 148 μg, or placebo QD AM for 26 weeks. Safety was assessed by monitoring treatment-emergent adverse events (TEAEs). Quality of life was assessed by using a rhinoconjunctivitis quality of life questionnaire with standardized activities (RQLQ[S]) in patients with baseline RQLQ ≥3.00. Reflective total nasal symptom scores (rTNSS) and instantaneous total nasal symptom scores (iTNSS) over 26 weeks were also evaluated.

RESULTS:

In this study, 1111 patients were randomized. The overall incidence of TEAEs was comparable between the treatment groups. Treatment with CIC-HFA 74- or 148-μg doses showed improvements in RQLQ[S] [least squares (LS) mean change 0.40 and 0.37, respectively from baseline, p < 0.01 versus placebo for both], rTNSS (LS mean change 0.65 and 0.52, respectively from baseline; p ≤ 0.01 versus placebo for both), and iTNSS (LS mean change 0.51 and 0.42, respectively from baseline; p < 0.05 versus placebo for both) from baseline.

CONCLUSION:

In this study, once-daily treatment with CIC-HFA 74- or 148-μg doses over 26 weeks was well tolerated with comparable incidence of TEAEs between the treatment groups.

• Authors: William E Berger, Dale E Mohar, Craig LaForce, Gordon Raphael, Shailesh Y Desai, Holly Huang, Joseph Hinkle
• Journal: American journal of rhinology & allergy (Am J Rhinol Allergy) 2012 Jul-Aug Vol. 26 Issue 4 Pg. 302-7 ISSN: 1945-8932 [Electronic] United States
• PMID: 22801019 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Allergic Agents
• Nasal Sprays
• Pregnenediones
• ciclesonide

Topics

• Adult
• Anti-Allergic Agents (adverse effects)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Nasal Sprays
• Pregnenediones (administration & dosage, adverse effects)
• Quality of Life
• Rhinitis, Allergic, Perennial (drug therapy, psychology)