Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 y) (BY9010/CA-101) (POPCICLE)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Low Dose Continuous Treatment With Ciclesonide Over One Year on the Time to First Exacerbation in Children With Mild Asthma Versus Intermittent Treatment for Exacerbations|
- Time to First Exacerbation [ Time Frame: 12 months ]Basis was the Intention to Treat Population (ITT). Time to first exacerbation is defined as the time until the first asthma exacerbation, or to end of T12 visit (=last visit).
- Exacerbations (Post-hoc Analysis of Annual Rates) [ Time Frame: 12 months ]
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 [yrs] and race were identified to be important beside treatment.
The parameters centre and age [yrs] 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.
- Growth Velocity as Assessed by Stadiometric Height Measurement [ Time Frame: 12 months ]Standing height measured in millimeters with a wall-mounted stadiometer
- Mean Rate of Asthma Exacerbations Per Year [ Time Frame: 12 months ]
- Duration of Exacerbations [ Time Frame: 12 months ]
- Number of Exacerbations [ Time Frame: 12 months ]
- Drop-out Rate Due to Asthma Exacerbation [ Time Frame: 12 months ]
- Change in FEV1 as Percent Predicted and Absolute Values [ Time Frame: 12 months ]
- Morning and Evening PEF Measurements by Diary Entries [ Time Frame: 12 months ]
- Variation in PEF by Diary Entries [ Time Frame: 12 months ]
- Diurnal PEF Fluctuation [ Time Frame: 12 months ]
- Total Symptom Score by Diary Entries [ Time Frame: 12 months ]
- Percent Nights With Nocturnal Awakenings Due to Asthma Symptoms [ Time Frame: 12 months ]
- Rescue Medication Use by Diary Entries [ Time Frame: 12 months ]
- Number of Rescue Medication Free Days by Diary Entries [ Time Frame: 12 months ]
The number of rescue medication free days is the number of days during which the total puffs of rescue medication (salbutamol) use is 0.
Assessment during baseline period at visit B2, B3 and B4 and during treatment period at visit T1, T2, T4, T6, T8, T10 and T12/Tend.
- Number of Symptom Free Days by Diary Entries [ Time Frame: 12 months ]
- Quality of Life Assessments as Per Pediatric Asthma Quality of Life Questionnaires PAQLQ(S) and PACQLQ [ Time Frame: 12 months ]
- Physical Examination and Vital Signs [ Time Frame: 12 months ]
- Laboratory Work-up. [ Time Frame: 12 months ]
|Study Start Date:||January 2005|
|Study Completion Date:||April 2010|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Active Comparator: CIC 100
100µg, two puffs once daily, in the evening
Active Comparator: CIC 200
200µg, two puffs once daily, in the evening
|Placebo Comparator: Placebo||
two puffs once daily, in the evening
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163293
|Calgary, Canada, T2T5C7|
|Fleurimont, Canada, J1H 5M4|
|London,ON, Canada, N6A1V2|
|London, Canada, N6C 4Y7|
|Winnipeg, Canada, R3A1R9|
|Kapstadt, South Africa|
|Study Chair:||Allan Becker, Dr||Children's Hospital, Winnipeg, Manitoba, Canada|