Phase 3
Completed N=1,080
A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma
Source: ClinicalTrials.gov NCT00384189 ↗Enrolled (actual)
1,080
Serious AEs
1.1%
Results posted
Aug 2016
Primary outcomePrimary: Change From Baseline in Morning Peak Expiratory Flow (PEF) — 15.23; 14.79; 17.37; 5.40 liters/minute — p=0.0116
◆ Published Evidence
Established
40citations · ~3 / year
Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: the RAINBOW study.
Summary
The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.
Linked Publications
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Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: the RAINBOW study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Morning Peak Expiratory Flow (PEF) |
15.23; 14.79; 17.37; 5.40 | 0.0116 sig |
| SECONDARY Time to First Event of Lack of Efficacy (LOE) by Week 12 |
72.8; 74.5; 73.2; 66.9 | 0.1362 |
| SECONDARY Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation |
7.14; 10.53; 6.67; 0.0 | 0.0010 sig |
| SECONDARY Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1) |
0.123; 0.122; 0.139; 0.039 | — |
| SECONDARY Change From Baseline in Lung Function Variable PEF by Spirometry |
20.68; 21.71; 22.25; 15.13 | — |
| SECONDARY Change From Baseline in Morning PEF From Diary |
11.61; 9.20; 11.54; 4.54; 9.82; 11.95 | — |
| SECONDARY Change From Baseline in Evening PEF From Diary |
10.16; 9.37; 12.71; 4.02 | — |
| SECONDARY Change From Baseline in Diurnal PEF Fluctuations |
-0.841; -1.209; -1.192; 0.214 | — |
| SECONDARY Change in Asthma Symptom Total Score |
-0.916; -0.983; -0.879; -0.572; -0.529; -0.553 | — |
| SECONDARY Change in Use of Rescue Medications |
-0.872; -0.999; -0.886; -0.527 | — |
| SECONDARY Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF |
8.33; 13.64; 13.04; 0.0 | — |
| SECONDARY Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score |
0.78; 0.71; 0.72; 0.43 | — |
| SECONDARY Change From Baseline in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall |
0.82; 0.88; 0.84; 0.71 | — |
Eligibility Criteria
Main Inclusion Criteria:
- History of asthma for at least 6 months
- Ability to show optimal use of MDI, including inhalation technique
- Lung function and reversibility within specified limits
Main Exclusion Criteria:
- Concomitant severe diseases
- Diseases which are contraindications for the use of inhaled steroids
- Two or more inpatient hospitalizations for asthma within the last year
- Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
- Use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6 weeks)
- Beginning of or change in immunotherapy within the last 6 months prior to inclusion
- Inability to follow the procedures of the study
Data sourced from ClinicalTrials.gov (NCT00384189) and the linked publication. 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.