Approval Probability
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Ciclesonide · 14 trials · 7 indications
The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
| Arm | Type | Description |
|---|---|---|
| Ciclesonide 200 mcg | EXPERIMENTAL | Ciclesonide 200 mcg nasal spray, 2 actuations (sprays) per nostril (50 mcg ciclesonide/actuation), daily, for 2 weeks. |
| Placebo | PLACEBO_COMPARATOR | Ciclesonide placebo-matching nasal spray, 2 actuations (sprays) per nostril, daily, for 2 weeks. |
| CIC 160 | ACTIVE_COMPARATOR | Two puffs of 40 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 160 mcg) |
| CIC 320 | ACTIVE_COMPARATOR | Two puffs of 80 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 320 mcg) |
| CIC 640 | ACTIVE_COMPARATOR | Two puffs of 160 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 640 mcg) |
| 1 | ACTIVE_COMPARATOR | Ciclesonide 200µg |
| 2 | PLACEBO_COMPARATOR | Placebo |
| 3 | ACTIVE_COMPARATOR | Ciclesonide 25µg |
| 4 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Ciclesonide | DRUG | Ciclesonide nasal spray 50 mcg/actuation |
| Ciclesonide Placebo | DRUG | Ciclesonide placebo-matching nasal spray |
| Ciclesonide Nasal Spray | DRUG | - |
| Placebo | DRUG | placebo |
| Ciclesonide nasal | DRUG | safety of Ciclesonide (200µg, 100µg, 25µg) |
Inclusion Criteria: 1. Informed consent signed by a participant for participation in the study. 2. SAR male and female participants aged greater than or equal to (\>=) 18 years (with a history of SAR of 2 years on longer). In the Investigator's judgment the SAR must have been of sufficient severity...
Ciclesonide is an investigational small molecule in Phase 3 development for asthma, bronchial asthma, rhinitis, allergic, seasonal, seasonal allergic rhinitis, hay fever, and perennial allergic rhinitis. It is being studied in the respiratory therapeutic area. The drug has been evaluated in 19 completed clinical trials with a total enrollment of 6,995 participants.
Ciclesonide is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this respiratory drug candidate for asthma and allergic rhinitis indications. AstraZeneca has completed 19 trials involving the drug, with all trials now closed.
Ciclesonide is in Phase 3 clinical development for respiratory conditions including asthma and allergic rhinitis. It is an investigational drug and has not been reported as FDA approved. All 19 clinical trials listed for Ciclesonide are completed, with no active trials currently enrolling patients.
Ciclesonide has completed 19 clinical trials, including NCT00163345, NCT00163397, NCT00306163, and NCT00314509. These Phase 3 and Phase 2 studies evaluated the drug in asthma patients across countries such as the Netherlands, Malaysia, Taiwan, France, Germany, Hungary, and South Africa. The trials were randomized, double-blind, and active-controlled.
Ciclesonide is the generic name for the drug also known by the brand name Alvesco. The data provided does not list alternative names, so this relationship is not confirmed in the available information. Ciclesonide is being studied for asthma and allergic rhinitis indications.