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Efficacy and tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis
- Source :
- Allergy and asthma proceedings. 33(1)
- Publication Year :
- 2012
-
Abstract
- A new nasal aerosol solution formulation of ciclesonide containing a hydrofluoroalkane propellant (CIC-HFA) delivered via a metered-dose inhaler is currently in clinical development as a potential treatment for allergic rhinitis (AR). This study evaluated the efficacy and tolerability of CIC-HFA 74- or 148-microgram doses compared with placebo in patients with perennial AR (PAR). 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 micrograms, CIC-HFA 148 micrograms, or placebo q.d. in the morning (A.M.) for 26 weeks. Change from baseline in reflective total nasal symptom score (rTNSS), instantaneous total nasal symptom score (iTNSS), and rhinoconjunctivitis quality-of-life questionnaire with standardized activities (RQLQ[S]) in patients with baseline RQLQ of ≥3.00 were evaluated for the first 6 weeks of treatment. Treatment-emergent adverse events (TEAEs) were monitored throughout the study. Eleven hundred eleven patients were randomized. CIC-HFA 74- and 148-microgram doses showed statistically significant improvements in rTNSS (least squares [LS] mean change, 0.70 and 0.54, respectively; p ≤ 0.001 versus placebo for both), iTNSS (LS mean change, 0.58 and 0.42, respectively; p < 0.05 versus placebo for both), and RQLQ[S] (LS mean change, 0.55 and 0.37, respectively; p < 0.01 versus placebo for both) from baseline. The overall incidence of TEAEs was comparable between the CIC-HFA treatment groups and placebo. In this study, once-daily treatment with CIC-HFA 74- or 148-micrograms showed statistically significant improvements in nasal symptoms of PAR. Both doses were well tolerated. Clinical trial registration URL and registration number: www.clinicaltrials.gov/ct2/show/NCT00953147.
- Subjects :
- Pulmonary and Respiratory Medicine
Adult
Male
medicine.medical_specialty
Rhinitis, Allergic, Perennial
Ciclesonide
Placebo
chemistry.chemical_compound
Young Adult
Drug Delivery Systems
Pregnenediones
Internal medicine
Anti-Allergic Agents
medicine
Immunology and Allergy
Humans
Adverse effect
business.industry
Inhaler
Incidence (epidemiology)
General Medicine
Nasal Sprays
Middle Aged
United States
Clinical trial
Treatment Outcome
Tolerability
chemistry
Tolerability Study
Quality of Life
Female
business
Follow-Up Studies
Subjects
Details
- ISSN :
- 15396304
- Volume :
- 33
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Allergy and asthma proceedings
- Accession number :
- edsair.doi.dedup.....75f08e9d09372725351a890315ccc3d8