Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ciclesonide/Formoterol Combination · 19 trials · 1 indication
Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to \<12 years only. Least Squares Mean were adjusted for Baseline FEV1, age \[yrs\], pooled center, previous corticosteroid therapy and holding chamber.
PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. Last observation carried forward.
Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron
Time to first asthma exacerbation is defined as the time in days until the first asthma exacerbation, or to the end of treatment visit. In the absence of an exacerbation, an early treatment discontinuation is treated as a censored observation on the day following the last use of study drug.
A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age \[years\] and race were identified to be important beside treatment. The parameters centre and age \[years\] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution.
| Arm | Type | Description |
|---|---|---|
| Placebo MDI | PLACEBO_COMPARATOR | double-blind |
| Ciclesonide MDI 40 µg BID | EXPERIMENTAL | double-blind |
| Ciclesonide MDI 80 µg BID | EXPERIMENTAL | double-blind |
| Ciclesonide 40 µg | ACTIVE_COMPARATOR | Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| Ciclesonide 80 µg | ACTIVE_COMPARATOR | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| Ciclesonide 160 µg | ACTIVE_COMPARATOR | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| Placebo | PLACEBO_COMPARATOR | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| 1 | ACTIVE_COMPARATOR | Ciclesonide 160 µg |
| 2 | ACTIVE_COMPARATOR | Fluticasone 100 µg |
| 3 | ACTIVE_COMPARATOR | Ciclesonide 160 µg |
| 4 | PLACEBO_COMPARATOR | Placebo |
| Ciclesonide 100 µg | ACTIVE_COMPARATOR | Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months. |
| Ciclesonide 200 µg | ACTIVE_COMPARATOR | Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months. |
| Name | Type | Description |
|---|---|---|
| Ciclesonide | DRUG | Ciclesonide MDI 40 µg BID over twelve weeks |
| Placebo | DRUG | Placebo MDI over twelve weeks |
| Salbutamol | DRUG | Salbutamol inhalation powder |
| Fluticasone | DRUG | inhaled Fluticasone 100 µg, twice daily |
| Ciclesonide/Formoterol Combination | DRUG | - |
Inclusion Criteria: * History of persistent bronchial asthma for at least 3 months prior to screening; * For patients with persistent bronchial asthma and being treated with a controller therapy: Documented use of an inhaled steroid or Singulair® 5mg once daily; * For patients with persistent bronc...
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.