Efficacy and safety of ciclesonide nasal spray for the treatment of seasonal allergic rhinitis.
BACKGROUND
Allergic rhinitis (AR), an inflammatory disease of the nasal mucosa, affects approximately 25% of adults and 40% of children in the United States. Ciclesonide nasal spray is a corticosteroid being developed as a hypotonic formulation for AR.


OBJECTIVE
We sought to evaluate the efficacy, safety, and tolerability of ciclesonide nasal spray in adult and adolescent patients with seasonal AR (SAR).


METHODS
In this double-blind study patients (age, >or=12 years) were randomized to receive 200 microg of intranasal ciclesonide (n = 164) or placebo (n = 163) once daily for 28 days. The primary measure was morning and evening patient-assessed reflective total nasal symptom score (TNSS). Additionally, instantaneous TNSSs, physician-assessed overall nasal signs and symptoms severity, and the results of the Rhinoconjunctivitis Quality of Life Questionnaire were evaluated. Adverse events were monitored throughout the study.


RESULTS
Ciclesonide significantly improved average morning and evening reflective and instantaneous TNSSs compared with placebo over days 1 to 14 (P < .001). Improvements were also noted over days 1 to 28 (P < .001) and over days 15 to 28 (P = .011). Ciclesonide was well tolerated.


CONCLUSIONS
Intranasal ciclesonide was superior to placebo in relieving nasal symptoms in adult and adolescent patients with SAR. These results confirm the dose range-finding study in patients with SAR and support the efficacy of ciclesonide in AR.


CONCLUSIONS
In a clinical setting ciclesonide was shown to be safe and effective in the treatment of SAR in adolescent and adult patients.
Ratner
Paul H
PH
Sylvana Research, Department of Pediatrics, University of Texas Health Science Center, San Antonio, TX 78229, USA. phratner@swbell.net <phratner@swbell.net>
Wingertzahn
Mark A
MA
van Bavel
Julius H
JH
Hampel
Frank
F
Darken
Patrick F
PF
Shah
Tushar
T
D000281:Administration, Intranasal; D000328:Adult; D000336:Aerosols; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011282:Pregnenediones / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000276:immunology; D016896:Treatment Outcome
D000336:Aerosols; D018926:Anti-Allergic Agents; D011282:Pregnenediones; C120481:ciclesonide