Phase 3
Completed N=240
Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)
Source: ClinicalTrials.gov NCT00163293 ↗Enrolled (actual)
240
Serious AEs
2.5%
Results posted
Dec 2010
Primary outcomePrimary: Time to First Asthma Exacerbation — 225.1; 249.5; 227.2 days — p=0.6625
Summary
The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Asthma Exacerbation |
225.1; 249.5; 227.2 | 0.6625 |
| PRIMARY Exacerbations (Post-hoc Analysis of Annual Rates) |
0.9343; 0.8794; 1.2621 | 0.1291 |
| SECONDARY Growth Velocity as Assessed by Stadiometric Height Measurement |
55.32; 64.60; 54.91 | — |
| SECONDARY Mean Rate of Asthma Exacerbations Per Year |
0.88; 0.85; 3.28 | 0.4754 |
| SECONDARY Duration of Exacerbations |
9.17; 9.31; 7.92 | — |
| SECONDARY Number of Exacerbations Per Participant |
0.72; 0.78; 0.95 | — |
| SECONDARY Percentage of Participants Who Dropped-out Due to Asthma Exacerbation |
1.3; 1.3; 4.8 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) |
0.019; 0.018; 0.012; 0.024; 0.060; 0.005 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) |
1.0; 0.6; 1.0; 1.4; 3.4; 0.3 | — |
| SECONDARY Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries |
235.72; 238.16; 241.89; 232.09; 234.41; 233.81 | — |
| SECONDARY Change From Baseline in PEF by Diary Entries |
8.46; 8.54; 6.06; 11.69; 10.82; 7.54 | — |
| SECONDARY Change From Baseline in Diurnal PEF Fluctuation |
-0.59; 0.06; 0.00; -0.13; -0.16; 0.15 | — |
| SECONDARY Total Asthma Symptom Score by Diary Entries |
0.37; 0.22; 0.32; 0.26; 0.14; 0.28 | — |
| SECONDARY Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms |
2.40; 1.64; 1.85; 1.96; 0.62; 1.73 | — |
| SECONDARY Rescue Medication Use Per Day |
1.00; 0.83; 0.87; 0.99; 0.53; 0.97 | — |
| SECONDARY Percentage of Rescue Medication Free Days |
47.94; 47.34; 44.37; 48.78; 54.46; 45.31 | — |
| SECONDARY Percentage of Asthma Symptom Free Days |
37.32; 36.95; 35.00; 38.47; 41.16; 33.56 | — |
| SECONDARY Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) |
6.21; 6.27; 6.08; 6.33; 6.26; 6.30 | — |
| SECONDARY Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) |
5.87; 6.16; 6.08; 6.15; 6.16; 6.31 | — |
| SECONDARY Number of Participants With Clinically Significant Vital Signs Findings |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Physical Examination Findings |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Values |
0; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events |
61; 64; 63; 2; 2; 2 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Outpatients
- Symptoms consistent with the diagnosis of asthma for at least 12 months
- Forced Expiratory Volume in one Second (FEV) at least 80% of predicted
- Participants who have a history of reversible airway obstruction
- Good health with the exception of asthma
Main Exclusion Criteria:
- History of life-threatening asthma
- A hospitalization for asthma within the last 3 months, or more than two hospitalizations for asthma within the last year
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- Participants suffering from relevant lung diseases causing alternating impairment in lung function (e.g. chronic bronchitis or emphysema)
- Prematurely born children (<36 weeks of gestation)
- Smokers
- Pregnancy (or intention to become pregnant during the course of the trial), breast feeding or lack of safe contraception by female of child-bearing potential
Data sourced from ClinicalTrials.gov (NCT00163293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.