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A 26-week Tolerability Study of Ciclesonide Nasal Aerosol in Patients with Perennial Allergic Rhinitis
- Source :
- American Journal of Rhinology & Allergy. 26:302-307
- Publication Year :
- 2012
- Publisher :
- SAGE Publications, 2012.
-
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.
- Subjects :
- Adult
Male
medicine.medical_specialty
Rhinitis, Allergic, Perennial
Ciclesonide
Placebo
chemistry.chemical_compound
Double-Blind Method
Quality of life
Pregnenediones
Internal medicine
Anti-Allergic Agents
medicine
Humans
Immunology and Allergy
Adverse effect
business.industry
Incidence (epidemiology)
Nasal Sprays
General Medicine
Middle Aged
Metered-dose inhaler
Otorhinolaryngology
chemistry
Tolerability
Tolerability Study
Quality of Life
Female
business
Subjects
Details
- ISSN :
- 19458932 and 19458924
- Volume :
- 26
- Database :
- OpenAIRE
- Journal :
- American Journal of Rhinology & Allergy
- Accession number :
- edsair.doi.dedup.....97eb70fb0d9421d2498b885b055013e7