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Dose-dependent effectiveness of ciclesonide nasal spray in the treatment of seasonal allergic rhinitis (SAR)
S28 Abstracts
SATURDAY 14
Dose-Dependent Effectiveness of Ciclesonide Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)
P. H. Ratner1, J. H. van Bavel2, F. Hampel3, M. A. Wingertzahn4, P. F. Darken4, T. Shah4, S. Hellbardt5, S. Brookman6; 1Sylvana Research Associates, San Antonio, TX, 2Allergy and Asthma Associates, Austin, TX, 3Central Texas Health Research, New Braunfels, TX, 4ALTANA Pharma, Florham Park, NJ, 5ALTANA Pharma, Konstantz, GERMANY, 6Clinical Research and Regulatory Affairs, Teijin America, Inc., Princeton, NJ. RATIONALE: Ciclesonide, a new corticosteroid under development for treatment of allergic rhinitis, was studied to determine the optimal dose in patients with SAR. METHODS: This was a multicenter, randomized, double-blind, placebocontrolled, study. Following a 1-week Baseline Period, patients were randomized to 14-days of treatment with placebo or ciclesonide (25-200 µg/day). The primary endpoint was the sum of AM and PM reflective total nasal symptom scores (TNSS). The study population consisted of approximately 145 adult patients/group with a minimum 2-year history of SAR. During the treatment period patients administered randomized study medication each morning and recorded morning and evening SAR symptoms. Safety was also monitored throughout the study. Data are expressed as LS means and analyses were performed using a repeated measures ANOVA model. RESULTS: Baseline TNSS was 17.8, 18.7, 18.4, 18.7 and 18.8, out of 24, for placebo and ciclesonide 25, 50, 100, 200 µg/day groups respectively. Over 14-days of treatment, the average change from baseline in TNSS was –4.2 for placebo, and –4.8, –4.8, –5.3, and –5.8 for ciclesonide 25, 50, 100, and 200 µg/day groups respectively. Only changes in TNSS for the ciclesonide 100 and 200 µg/day groups were statistically different versus placebo (p=0.0398 and 0.0033, respectively). There were no appreciable differences in the incidence of adverse events among treatment groups. CONCLUSIONS: Results from this study support that the 100 and 200 µg daily doses of ciclesonide are effective in the treatment of SAR. Additionally, the 200 µg dose appears to provide the greatest benefit in reducing the symptoms of SAR. Funding: ALTANA Pharma
J ALLERGY CLIN IMMUNOL FEBRUARY 2004
SATURDAY 14
Dose-Dependent Effectiveness of Ciclesonide Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)
P. H. Ratner1, J. H. van Bavel2, F. Hampel3, M. A. Wingertzahn4, P. F. Darken4, T. Shah4, S. Hellbardt5, S. Brookman6; 1Sylvana Research Associates, San Antonio, TX, 2Allergy and Asthma Associates, Austin, TX, 3Central Texas Health Research, New Braunfels, TX, 4ALTANA Pharma, Florham Park, NJ, 5ALTANA Pharma, Konstantz, GERMANY, 6Clinical Research and Regulatory Affairs, Teijin America, Inc., Princeton, NJ. RATIONALE: Ciclesonide, a new corticosteroid under development for treatment of allergic rhinitis, was studied to determine the optimal dose in patients with SAR. METHODS: This was a multicenter, randomized, double-blind, placebocontrolled, study. Following a 1-week Baseline Period, patients were randomized to 14-days of treatment with placebo or ciclesonide (25-200 µg/day). The primary endpoint was the sum of AM and PM reflective total nasal symptom scores (TNSS). The study population consisted of approximately 145 adult patients/group with a minimum 2-year history of SAR. During the treatment period patients administered randomized study medication each morning and recorded morning and evening SAR symptoms. Safety was also monitored throughout the study. Data are expressed as LS means and analyses were performed using a repeated measures ANOVA model. RESULTS: Baseline TNSS was 17.8, 18.7, 18.4, 18.7 and 18.8, out of 24, for placebo and ciclesonide 25, 50, 100, 200 µg/day groups respectively. Over 14-days of treatment, the average change from baseline in TNSS was –4.2 for placebo, and –4.8, –4.8, –5.3, and –5.8 for ciclesonide 25, 50, 100, and 200 µg/day groups respectively. Only changes in TNSS for the ciclesonide 100 and 200 µg/day groups were statistically different versus placebo (p=0.0398 and 0.0033, respectively). There were no appreciable differences in the incidence of adverse events among treatment groups. CONCLUSIONS: Results from this study support that the 100 and 200 µg daily doses of ciclesonide are effective in the treatment of SAR. Additionally, the 200 µg dose appears to provide the greatest benefit in reducing the symptoms of SAR. Funding: ALTANA Pharma
J ALLERGY CLIN IMMUNOL FEBRUARY 2004