| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00392288 | Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma. | PHASE3 | COMPLETED | 528 | — | — | Sep 1, 2006 | Feb 1, 2008 | Feb 1, 2017 | 6 | United States, Hungary +4 |
| NCT00384189 | A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma | PHASE3 | COMPLETED | 1,080 | — | — | Sep 1, 2006 | Aug 1, 2008 | Feb 1, 2017 | 122 | Bulgaria, Germany +7 |
| NCT00306163 | Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101) | PHASE3 | COMPLETED | 37 | — | — | May 1, 2006 | Sep 1, 2008 | Feb 1, 2017 | 1 | Netherlands |
| NCT00305461 | Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101) | PHASE3 | COMPLETED | 101 | — | — | Feb 1, 2006 | Feb 1, 2008 | Dec 5, 2016 | 12 | Argentina |
| NCT00163449 | Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207) | PHASE3 | COMPLETED | 1,000 | — | — | Nov 1, 2005 | May 1, 2007 | Dec 8, 2016 | 96 | Brazil, Germany +7 |
| NCT00163371 | Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208) | PHASE3 | COMPLETED | 28 | — | — | Sep 1, 2005 | Dec 1, 2005 | Dec 1, 2016 | 1 | Denmark |
| NCT00163436 | Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145) | PHASE3 | COMPLETED | 450 | — | — | Sep 1, 2005 | Jan 1, 2006 | Nov 30, 2016 | 66 | Canada, France +4 |
| NCT00163293 | Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101) | PHASE3 | COMPLETED | 240 | — | — | Jan 1, 2005 | Apr 1, 2010 | Apr 26, 2017 | 7 | Canada, Hungary +1 |
| NCT00163319 | Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101) | PHASE3 | COMPLETED | 500 | — | — | Nov 1, 2004 | Nov 1, 2005 | Dec 2, 2016 | 89 | Belgium, France +5 |
| NCT00163423 | Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142) | PHASE3 | COMPLETED | 480 | — | — | Nov 1, 2004 | Jan 1, 2006 | Dec 8, 2016 | 51 | Austria, Canada +3 |
| NCT00163462 | Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206) | PHASE3 | COMPLETED | 750 | — | — | Oct 1, 2004 | Nov 1, 2005 | Dec 5, 2016 | 57 | Brazil, Germany +4 |
| NCT00163397 | Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137) | PHASE3 | COMPLETED | 120 | — | — | Jan 1, 2004 | Jul 1, 2005 | Nov 30, 2016 | 6 | Malaysia, Taiwan |
| NCT00163384 | Effectiveness of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-136) | PHASE3 | COMPLETED | 240 | — | — | Jan 1, 2004 | May 1, 2005 | Nov 30, 2016 | 19 | South Korea |
| NCT00163358 | Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132) | PHASE3 | COMPLETED | 630 | — | — | Sep 1, 2003 | Oct 1, 2005 | Nov 30, 2016 | 111 | Australia, Canada +5 |
| NCT00163345 | Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131) | PHASE3 | COMPLETED | 20 | — | — | Sep 1, 2003 | May 1, 2006 | Dec 8, 2016 | 1 | Netherlands |
| NCT00163410 | Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205) | PHASE3 | COMPLETED | 500 | — | — | Apr 1, 2003 | Dec 1, 2004 | Dec 2, 2016 | 16 | India |
| NCT00163332 | Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129) | PHASE3 | COMPLETED | 30 | — | — | Mar 1, 2003 | - | Dec 6, 2016 | 5 | Belgium |
| NCT00546520 | Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125) | PHASE3 | COMPLETED | 21 | — | — | Apr 1, 2002 | Jun 1, 2002 | Dec 7, 2016 | 1 | United Kingdom |
| NCT00314509 | Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506) | PHASE2 | COMPLETED | 240 | — | — | Jul 1, 2005 | Jan 1, 2006 | Dec 5, 2016 | 26 | France, Germany +2 |
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...