Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ciclesonide HFA · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Ciclesonide HFA 75 mcg (37,5 mcg / actuation, 1 actuation/nostril), once daily |
| 2 | ACTIVE_COMPARATOR | Ciclesonide HFA 150 mcg (75 mcg / actuation, 1 actuation/nostril), once daily |
| 3 | ACTIVE_COMPARATOR | Ciclesonide HFA 300 mcg (150 mcg / actuation, 1 actuation/nostril), once daily |
| 4 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Ciclesonide HFA | DRUG | 75 mcg Ciclesonide HFA versus Placebo |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Male or female 12 years and older 2. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct,influence the interpretation of study observations/results, or put the patient at increases risk during the trial 3. A history...
Ciclesonide HFA is being developed for the treatment of seasonal allergic rhinitis in adults and adolescents 12 years of age and older. It is a nasal aerosol formulation studied for this respiratory indication. The program is currently at Phase 2, so the drug is investigational and not yet approved for commercial use.
Ciclesonide HFA targets NR3C1, the glucocorticoid receptor, and acts as an agonist at this receptor. By binding and activating NR3C1, the drug is designed to produce anti-inflammatory effects relevant to allergic rhinitis. NR3C1 agonism is the mechanism underlying its therapeutic activity in seasonal allergic rhinitis.
Ciclesonide HFA is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this nasal aerosol formulation for seasonal allergic rhinitis.
Ciclesonide HFA is in Phase 2 development. It is an investigational small molecule and has not been approved by the FDA. The Phase 2 program for seasonal allergic rhinitis has been completed, with no active trials currently listed for this asset.
Ciclesonide HFA has been studied in one completed Phase 2 trial, NCT00807053, titled a dose-ranging study to assess the efficacy and safety of Ciclesonide HFA nasal aerosol in patients 12 years and older with seasonal allergic rhinitis. The trial enrolled 480 participants in the United States and was randomized, double-blind, and placebo-controlled.