A study of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol in patients with seasonal allergic rhinitis from mountain cedar pollen

Abstract

A nasal aerosol formulation of ciclesonide with a hydrofluoroalkane propellant (CIC-HFA) is currently in development for treatment of allergic rhinitis (AR). This study evaluated the efficacy and safety of once-daily administration of CIC-HFA 74 or 148 micrograms compared with placebo in patients with seasonal AR (SAR) from mountain cedar pollen. Patients ≥12 years of age with a ≥2-year history of SAR from mountain cedar pollen were randomized in a placebo-controlled, double-blind, parallel group, multicenter study to CIC-HFA 74 micrograms, CIC-HFA 148 micrograms, or placebo once daily in the morning for 2 weeks. Change from baseline in reflective total nasal symptom score (rTNSS), instantaneous TNSS (iTNSS), and reflective total ocular symptom score (rTOSS) in patients with baseline rTOSS ≥5.00 were evaluated. Adverse events (AEs) were monitored throughout the study. A statistically significant improvement in rTNSS (least squares [LS] mean change from baseline 1.04 and 1.02 respectively; p < 0.0001 versus placebo for both) and iTNSS (LS mean change from baseline 0.90 and 0.83 respectively; p < 0.001 vs placebo for both) was observed after treatment with CIC-HFA 74- or 148-microgram doses. Only the CIC-HFA 74-micrograms treatment group showed a statistically significant improvement in rTOSS (LS mean change from baseline 0.52; p = 0.0124) compared with placebo. The overall incidence of AEs was low and comparable between the treatment groups. In this study, statistically significant improvements in nasal symptoms of SAR were observed after treatment with CIC-HFA 74-microgram or CIC-HFA 148-microgram doses. Both active treatments were well tolerated. Clinical trial registry URL and registration number: www.clinicaltrials.gov/ct2/show/NCT01010971.

Epistaxis Risk Associated with Intranasal Corticosteroid Sprays: A Systematic Review and Meta‐analysis

“…The risk ratio for patients treated with ciclesonide HFA was 1.26 (95% CI, 0.87-1.83; I 2 = 0%; Figure 8B ). 66-69 The risk ratio for patients treated with beclomethasone aqueous was 1.24 (95% CI, 0.84-1.81; I 2 = 11%; Figure 4A ). 42,45,62,65,70-73 The risk ratio for patients treated with ciclesonide aqueous was 1.16 (95% CI, 0.83-1.62; I 2 = 0%; Figure 8A ).…”

Rhinitis 2020: A practice parameter update

“…364 To address some of these concerns, nonaqueous intranasal preparations with hydrofluoroalkane aerosol are now available for the treatment of AR in the United States. [365][366][367] When given in recommended doses, INCS are not generally associated with clinically significant systemic side effects. 1 They have not been shown to affect the hypothalamic-pituitaryadrenal axis.…”

Intranasal Spray Medications for Maintenance Therapy of Allergic Rhinitis

“…Twenty studies met the inclusion criteria: 4 pediatric studies (PAR, 1; SAR, 3) 31–34 and 16 adult and/or adolescent trials (PAR, 3; SAR, 13). 35–51 The PAR studies included 1988 subjects (381 children, 1607 adults); 1245 (190 children, 1055 adults) received an INCS for 4-26 weeks. 31,35–38 The SAR studies were all 2-week trials and included 9629 subjects (3081 children, 6548 adults).…”