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The primary objective of this study is to demonstrate the safety of three dose levels of ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to measure serum concentrations of ciclesonide and its active metabolite under steady state conditions at three time points corresponding to the presumed peak and trough exposure after six weeks of administration.
In addition, reflective (24-hour) total nasal symptom score (TNSS) over the six weeks of treatment at various timepoints and a physician assessment of nasal symptoms at endpoint were summarized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Ciclesonide 200µg |
|
| 2 | Active Comparator | Ciclesonide 100µg |
|
| 3 | Active Comparator | Ciclesonide 25µg |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide nasal | Drug | safety of Ciclesonide (200µg, 100µg, 25µg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous and elicited adverse events (AEs) | 6 weeks | |
| Vital signs | 6 weeks | |
| Cortisol (24-hour urine. AM plasma) | 6 weeks | |
| clinical laboratory parameters | 6 weeks | |
| Physical examination including ENT exam | 6 weeks | |
| Intraocular pressure (IOP) assessment | 6 weeks | |
| serum concentrations of ciclesonide and its active metabolite will be measured following 6 weeks treatment at three time points corresponding to presumed peak and trough exposure | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| reflective (24-hour) total nasal symptom score (TNSS; including sneezing, runny nose, nasal itching and congestion) over 6 weeks of treatment and over other selected time points | 6 weeks | |
| a physician assessment of nasal symptoms at endpoint and at Visits T0, T3 and T6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altana/Nycomed | Little Rock | Arkansas | 72202 | United States |
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| Label | URL |
|---|---|
| BY9010-M1-405-RDS-2005-11-07.pdf | View source |
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| Placebo |
| Drug |
placebo |
|
| 6 weeks |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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