A 2-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, clinical trial of seasonal allergic rhinitis (SAR) patients 12 years of age and older. Patients (n=707) were randomized to receive once-daily ZETONNA® (ciclesonide) Nasal Aerosol 74 mcg, placebo, or a higher dose. The primary endpoint of the study was the patient-reported LS mean change from baseline in average of AM and PM rTNSS over days 1 to 14. rTNSS was calculated as a sum of the 4 individual nasal symptoms: nasal congestion, nasal itching, sneezing, and runny nose.2
In addition, ZETONNA demonstrated statistically significant improvements in AM instantaneous Total Nasal Symptoms Score (iTNSS) from baseline vs placebo (-1.32 vs -0.46; P<.0001) for a full 24 hours1,4
A 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter, clinical trial of patients 12 years of age and older with perennial allergic rhinitis (PAR). Patients (n=1110) were randomized to receive once-daily ZETONNA® (ciclesonide) Nasal Aerosol 74 mcg, placebo, or a higher dose. The primary endpoint of the study was the patient-evaluated change from baseline in average of AM and PM rTNSS over days 1 to 42.3
In addition, ZETONNA demonstrated statistically significant improvements in iTNSS from baseline (days 1-42) vs placebo (-1.8 vs -1.2; P<0.001) for patients with PAR1,5
A 2-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, clinical trial of SAR patients 12 years of age and older. Patients (n=707) were randomized to receive once-daily ZETONNA® (ciclesonide) Nasal Aerosol 74 mcg, placebo or a higher dose. The primary endpoint of the study was the patient-reported LS mean change from baseline in average of AM and PM rTNSS over days 1 to 14. rTOSS was calculated as a sum of 3 individual ocular symptoms: redness of eyes, itching eyes, and tearing eyes.2
*Data shown are for the secondary endpoint, reductions in the overall symptom score, as measured by average of AM and PM rTOSS (LS mean change from baseline over days 1-14) in intent-to-treat population.1
1. ZETONNA Prescribing Information. Marlborough, MA: Sunovion Pharmaceuticals Inc; January 2012.
2. Ratner P, Jacobs R, Mohar D, et al. Evaluation of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol, 80 or 160 µg once daily, for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2010;105:471-479.
3. Mohar D, Berger W, LaForce C, et al. Efficacy and tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis. Allergy Asthma Proc.2012;33(1):19-26.
4. www.clinicaltrials.gov, NCT00790023. CSR 060-622. Sunovion Pharmaceuticals Inc., Marlborough, MA.
5. www.clinicaltrials.gov, NCT00953147. CSR 060-633. Sunovion Pharmaceuticals Inc., Marlborough, MA.
Stayability is a registered trademark of Sunovion Pharmaceuticals Inc.
In clinical studies local nasal effects of epistaxis, ulcerations, and nasal septal perforations were observed with ZETONNA® (ciclesonide) Nasal Aerosol. In the short-term and long term trials combined, nasal septal perforations were reported in 2 patients of 2335 treated with ZETONNA Nasal Aerosol compared with none of 892 treated with placebo. Both perforations occurred in 2 week SAR trials while none occurred in the longer term trials. In clinical trials with another formulation of ciclesonide, the development of localized infections of the nose or pharynx with Candida albicans has occurred. Corticosteroids can interfere with wound healing.
Prior to initiating therapy, examine patients for evidence of septal perforation, erosions, ulceration, nasal surgery, and trauma. Avoid spraying ZETONNA Nasal Aerosol directly onto the nasal septum. Avoid use in patients with recent septal perforation, nasal erosion, nasal ulcers, nasal surgery, or nasal trauma. Monitor patients periodically for signs of adverse reactions on the nasal mucosa. Discontinue ZETONNA Nasal Aerosol if erosions, ulcerations or perforations occur.
Nasal and inhaled corticosteroids may result in the development of glaucoma and cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, or cataracts.
ZETONNA Nasal Aerosol is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of ZETONNA Nasal Aerosol. Cases of hypersensitivity reactions following administration of ciclesonide with manifestations such as angioedema, with swelling of the lips, tongue and pharynx have been reported.
Patients who are using immunosuppressant doses of corticosteroids are more susceptible to infections than healthy individuals. Chicken pox and measles can have a more serious or even fatal course in susceptible individuals. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections; or ocular herpes simplex because of the potential for worsening of these infections.
When intranasal corticosteroids are used at very high dosages or at the regular dosage in susceptible individuals, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, discontinue ZETONNA Nasal Aerosol slowly.
Corticosteroids may cause a reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving ZETONNA Nasal Aerosol.
In trials 2-6 weeks in duration, the most common adverse reactions that occurred with an incidence of at least 2% and more frequently with ZETONNA Nasal Aerosol than with placebo were nasal discomfort (3.2%), headache (3.1%) and epistaxis (2.9%).
For additional information, please see the ZETONNA Nasal Aerosol Full Prescribing Information.
ZETONNA® (ciclesonide) Nasal Aerosol is a corticosteroid indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.