Asthma
Conditions
Keywords
Asthma, Ciclesonide, Exacerbation
Brief 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.
Detailed description
The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to treat children who have mild asthma. The study enrolled 240 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Ciclesonide 100 µg * Ciclesonide 200 µg * Placebo (dummy inactive inhalation) - this is a metered-dose inhaler that looks like the study drug but has no active ingredient. All participants were asked to take two puffs from a metered-dose inhaler once daily, in the evening, for up to 12 months. This multi-center trial was conducted in Canada, Hungary and South Africa. The overall time to participate in this study was 12 months preceded by a baseline washout period of 3 to 4 weeks. Participants made multiple visits to the clinic including a safety follow-up visit within 30 days of the last treatment.
Interventions
DRUGPlacebo
Ciclesonide placebo-matching metered-dose inhaler
DRUGCiclesonide
Ciclesonide metered-dose inhaler
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Asthma Exacerbation | Up to 12 months | 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. |
| Exacerbations (Post-hoc Analysis of Annual Rates) | Up to 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 \[years\] 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Exacerbations | Up to 12 months | Duration of exacerbation was defined as the time in days when the criteria for an exacerbation were met to the time when peak flow measurements returned to baseline. |
| Number of Exacerbations Per Participant | Up to 12 months | The mean number of asthma exacerbations per participant is reported. |
| Percentage of Participants Who Dropped-out Due to Asthma Exacerbation | Up to 12 months | — |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Baseline and Months 1, 2, 4, 6, 8, 10 and 12 | FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement. |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Baseline and Months 1, 2, 4, 6, 8, 10 and 12 | FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement. |
| Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Months 1, 2, 4, 6, 8, 10 and 12 | PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. |
| Change From Baseline in PEF by Diary Entries | Baseline and Months 1, 2, 4, 6, 8, 10 and 12 | PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. A positive change from Baseline indicates improvement. |
| Change From Baseline in Diurnal PEF Fluctuation | Baseline and Months 1, 2, 4, 6, 8, 10 and 12 | Diurnal PEF Fluctuation is equal to \[(Higher PEF - Lower PEF)/0.5\*(Higher PEF + Lower PEF)\] \* 100%. A positive change from Baseline indicates improvement. |
| Total Asthma Symptom Score by Diary Entries | Months 1, 2, 4, 6, 8, 10 and 12 | Total Asthma Score = daytime asthma score + night-time asthma score, where higher score indicates worsening of disease. Night-time asthma score is assessed on a 5 point scale where 0=No symptoms, slept through the night, 1=Slept well but some complaints in the morning, 2=Woke up once because of asthma (including early wakening), 3=Woke up several times because of asthma (including early wakening) and 4=Bad night, awake most of the night because of asthma. Day-time asthma score is assessed on a 5 point scale where 0= Very well, no symptoms, 1= One episode of wheezing, cough or breathlessness, 2= More than one episode of wheezing, cough or breathlessness without interfering with normal activities, 3= Wheezing, cough or shortness of breath most of the day which interfered to some extent with normal activities and 4= Asthma very bad. Unable to carry out daily activities as usual. |
| Growth Velocity as Assessed by Stadiometric Height Measurement | Up to 12 months | Standing height measured in millimeters (mm) with a wall-mounted stadiometer. |
| Rescue Medication Use Per Day | Months 1, 2, 4, 6, 8, 10 and 12 | Salbutamol (100 μg/puff) was used as rescue medication according to the individual needs of the participant. Each use was documented in the participant's diary. |
| Percentage of Rescue Medication Free Days | Months 1, 2, 4, 6, 8, 10 and 12 | Days without use of rescue medication documented in the participant's diary were reported. |
| Percentage of Asthma Symptom Free Days | Months 1, 2, 4, 6, 8, 10 and 12 | Days without Asthma Symptom documented in the participant's diary were reported. |
| Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) | Months 2, 6 and 12 | The PAQLQ(S) consists of 23 items divided into three domains: Activity limitations (items 1-3, 19, 22); Symptoms (items 4, 6, 8, 10, 12, 14, 16, 18, 20, 23) and Emotional function (items 5, 7, 9, 11, 13, 15, 17, 21). Participants were asked to answer each question using a seven-point scale (where 1 indicated maximum impairment and 7 indicated no impairment) and recall their experience during the previous week. Overall PAQLQ score is equal to the mean of all 23 items for a total possible score 1 (worst) to 7 (best). |
| Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | Months 2, 6 and 12 | The PACQLQ consists of 13 items divided into two domains: Activity limitations (items 2, 4, 6, 8) and Emotional function (items 1, 3, 5, 7, 9, 10, 11, 12, 13). Caregivers answered each question using a seven-point scale (whereby 1 indicated maximum impairment and 7 indicated no impairment) and recalled their experiences during the previous week. Overall PACQLQ score is equal to the mean of all 13 items for a total possible score of 1 (worst) to 7 (best). |
| Number of Participants With Clinically Significant Vital Signs Findings | Up to 12 months | Vital signs included body temperature, systolic and diastolic blood pressure and heart rate in beats per minute (bpm). The investigator determined if the result was clinically significant based on the following criteria: Systolic Blood Pressure \>130 mmHg or \<80 mmHg or a \>20 mmHg difference from Baseline; Diastolic Blood Pressure \> 85 mmHg; and Resting Heart Rate \>140 bpm or \<60 bpm or a \>30 bpm difference from Baseline. |
| Number of Participants With Clinically Significant Physical Examination Findings | Up to 12 months | A thorough physical examination was performed consisting of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) lungs/thorax; (4) heart/cardiovascular system; (5) abdomen; (6) skin and mucosae; (7) nervous system; (8) lymph nodes; (9) musculo-skeletal system; (10) physical examinations other than body systems described in (1) to (9). The investigator determined if any of the findings were clinically significant. |
| Number of Participants With Clinically Significant Laboratory Values | Up to 12 months | Clinically significant laboratory values were hematology and chemistry tests determined by the investigator to be clinically significant based on the following criteria: Hemoglobin \<9.5 g/dL; Erythrocytes \<3.0 x 10\^6/μL or \>6.5 x 10\^6/μL; White Blood Count \<3000/mm\^3 or \>20000/mm\^3; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transpeptidase (GGT), Total Bilirubin and Glucose \>2 times Upper limit of Normal Range (ULNR); Alkaline Phosphatase and Creatine Kinase \>3 times ULNR; Creatinine \>1.5 times ULN; Potassium \>5.0 mmol/L or \<3.0 mmol/L; and Sodium \>150 mmol/L or 130 mmol/L. |
| Number of Participants With Adverse Events and Serious Adverse Events | Up to 12 months | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect or any other important medical condition considered serious based on medical and scientific judgement. |
| Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Months 1, 2, 4, 6, 8, 10 and 12 | Nocturnal awakenings due to asthma symptoms were recorded in the participant's diary. |
| Mean Rate of Asthma Exacerbations Per Year | Up to 12 months | Rate of asthma exacerbations per year is equal to total number of asthma exacerbations during treatment/time on treatment (year). |
Countries
Canada, Hungary, South Africa
Participant flow
Recruitment details
Participants took part in the study at 30 investigative sites in Canada, Hungary and South Africa from 24 January 2005 to 25 June 2009.
Pre-assignment details
Children who experienced symptoms consistent with mild asthma for at least 12 months were enrolled in 1 of 3 treatment groups: once a day placebo, 100 µg or 200 µg ciclesonide.
Participants by arm
| Arm | Count |
|---|---|
| Ciclesonide 100 µg Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months. | 79 |
| Ciclesonide 200 µg Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months. | 76 |
| Placebo Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months. | 84 |
| Total | 239 |
Baseline characteristics
| Characteristic | Ciclesonide 100 µg | Ciclesonide 200 µg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 7.9 years STANDARD_DEVIATION 2.06 | 7.7 years STANDARD_DEVIATION 1.84 | 8.1 years STANDARD_DEVIATION 2.19 | 7.9 years STANDARD_DEVIATION 2.04 |
| Body Mass Index (BMI) | 17.30 kg/m^2 STANDARD_DEVIATION 3.107 | 17.69 kg/m^2 STANDARD_DEVIATION 2.977 | 18.68 kg/m^2 STANDARD_DEVIATION 4.069 | 17.91 kg/m^2 STANDARD_DEVIATION 3.478 |
| Race/Ethnicity, Customized Asian | 6 participants | 6 participants | 6 participants | 18 participants |
| Race/Ethnicity, Customized Black | 4 participants | 2 participants | 5 participants | 11 participants |
| Race/Ethnicity, Customized Caucasian | 55 participants | 53 participants | 59 participants | 167 participants |
| Race/Ethnicity, Customized Other | 14 participants | 15 participants | 14 participants | 43 participants |
| Sex: Female, Male Female | 33 Participants | 31 Participants | 34 Participants | 98 Participants |
| Sex: Female, Male Male | 46 Participants | 45 Participants | 50 Participants | 141 Participants |
| Smoking Classification (Non-smoker) | 79 participants | 76 participants | 84 participants | 239 participants |
| Weight | 29.90 kg STANDARD_DEVIATION 9.701 | 30.01 kg STANDARD_DEVIATION 9.247 | 33.13 kg STANDARD_DEVIATION 11.64 | 31.08 kg STANDARD_DEVIATION 10.365 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 56 / 79 | 55 / 76 | 56 / 84 |
| serious Total, serious adverse events | 2 / 79 | 2 / 76 | 2 / 84 |
Outcome results
Primary
Exacerbations (Post-hoc Analysis of Annual Rates)
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.
Time frame: Up to 12 months
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide 100 µg | Exacerbations (Post-hoc Analysis of Annual Rates) | 0.9343 number of events per year | Standard Error 0.2909 |
| Ciclesonide 200 µg | Exacerbations (Post-hoc Analysis of Annual Rates) | 0.8794 number of events per year | Standard Error 0.2747 |
| Placebo | Exacerbations (Post-hoc Analysis of Annual Rates) | 1.2621 number of events per year | Standard Error 0.2768 |
p-value: 0.1291Wald Chi-square
p-value: 0.0145Wald Chi-square
Primary
Time to First Asthma Exacerbation
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.
Time frame: Up to 12 months
Population: Intention to Treat (ITT) analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide 100 µg | Time to First Asthma Exacerbation | 225.1 days | Standard Error 14.73 |
| Ciclesonide 200 µg | Time to First Asthma Exacerbation | 249.5 days | Standard Error 14.79 |
| Placebo | Time to First Asthma Exacerbation | 227.2 days | Standard Error 15.2 |
p-value: 0.6625Log Rank
p-value: 0.7303Log Rank
Secondary
Change From Baseline in Diurnal PEF Fluctuation
Diurnal PEF Fluctuation is equal to \[(Higher PEF - Lower PEF)/0.5\*(Higher PEF + Lower PEF)\] \* 100%. A positive change from Baseline indicates improvement.
Time frame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 2 (n=76, 71, 77) | -0.13 percent fluctuation | Standard Deviation 5.009 |
| Ciclesonide 100 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 10 (n=64, 70, 68) | -1.46 percent fluctuation | Standard Deviation 5.221 |
| Ciclesonide 100 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 12 (n=68, 70, 70) | -1.81 percent fluctuation | Standard Deviation 4.913 |
| Ciclesonide 100 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 1 (n=78, 76, 80) | -0.59 percent fluctuation | Standard Deviation 3.97 |
| Ciclesonide 100 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 4 (n=68, 71, 75) | -0.65 percent fluctuation | Standard Deviation 5.251 |
| Ciclesonide 100 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 6 (n=67, 72, 73) | -1.01 percent fluctuation | Standard Deviation 4.351 |
| Ciclesonide 100 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 8 (n=66, 70, 69) | -1.12 percent fluctuation | Standard Deviation 4.83 |
| Ciclesonide 200 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 8 (n=66, 70, 69) | -1.21 percent fluctuation | Standard Deviation 3.757 |
| Ciclesonide 200 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 6 (n=67, 72, 73) | -0.22 percent fluctuation | Standard Deviation 5.86 |
| Ciclesonide 200 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 10 (n=64, 70, 68) | -0.70 percent fluctuation | Standard Deviation 4.319 |
| Ciclesonide 200 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 2 (n=76, 71, 77) | -0.16 percent fluctuation | Standard Deviation 4.131 |
| Ciclesonide 200 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 4 (n=68, 71, 75) | -1.01 percent fluctuation | Standard Deviation 3.784 |
| Ciclesonide 200 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 12 (n=68, 70, 70) | -0.62 percent fluctuation | Standard Deviation 4.44 |
| Ciclesonide 200 µg | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 1 (n=78, 76, 80) | 0.06 percent fluctuation | Standard Deviation 3.772 |
| Placebo | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 12 (n=68, 70, 70) | -1.26 percent fluctuation | Standard Deviation 4.187 |
| Placebo | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 1 (n=78, 76, 80) | 0.00 percent fluctuation | Standard Deviation 3.867 |
| Placebo | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 2 (n=76, 71, 77) | 0.15 percent fluctuation | Standard Deviation 5.084 |
| Placebo | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 4 (n=68, 71, 75) | -0.55 percent fluctuation | Standard Deviation 4.421 |
| Placebo | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 6 (n=67, 72, 73) | -0.47 percent fluctuation | Standard Deviation 4.28 |
| Placebo | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 8 (n=66, 70, 69) | -1.11 percent fluctuation | Standard Deviation 4.048 |
| Placebo | Change From Baseline in Diurnal PEF Fluctuation | Change at Month 10 (n=64, 70, 68) | -1.14 percent fluctuation | Standard Deviation 4.059 |
Secondary
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value)
FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.
Time frame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 12 (n=65, 69, 65) | 0.161 liters | Standard Deviation 0.2022 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 4 (n=68, 72, 75) | 0.065 liters | Standard Deviation 0.1483 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 10 (n=66, 69, 67) | 0.143 liters | Standard Deviation 0.1458 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 2 (n=76, 73, 77) | 0.024 liters | Standard Deviation 0.1416 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 6 (n=67, 72, 72) | 0.091 liters | Standard Deviation 0.1714 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 8 (n=66, 71, 68) | 0.075 liters | Standard Deviation 0.2144 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 1 (n=78, 76, 81) | 0.019 liters | Standard Deviation 0.1715 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 8 (n=66, 71, 68) | 0.126 liters | Standard Deviation 0.2089 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 10 (n=66, 69, 67) | 0.168 liters | Standard Deviation 0.191 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 1 (n=78, 76, 81) | 0.018 liters | Standard Deviation 0.1639 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 12 (n=65, 69, 65) | 0.185 liters | Standard Deviation 0.2024 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 6 (n=67, 72, 72) | 0.125 liters | Standard Deviation 0.1975 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 4 (n=68, 72, 75) | 0.083 liters | Standard Deviation 0.1486 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 2 (n=76, 73, 77) | 0.060 liters | Standard Deviation 0.1582 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 12 (n=65, 69, 65) | 0.178 liters | Standard Deviation 0.1593 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 2 (n=76, 73, 77) | 0.005 liters | Standard Deviation 0.1416 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 6 (n=67, 72, 72) | 0.078 liters | Standard Deviation 0.1855 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 1 (n=78, 76, 81) | 0.012 liters | Standard Deviation 0.1627 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 4 (n=68, 72, 75) | 0.076 liters | Standard Deviation 0.1725 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 8 (n=66, 71, 68) | 0.120 liters | Standard Deviation 0.1855 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) | Change at Month 10 (n=66, 69, 67) | 0.146 liters | Standard Deviation 0.1609 |
Secondary
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted)
FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.
Time frame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 8 (n=66, 71, 68) | 4.4 percent predicted FEV1 | Standard Deviation 12.44 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 10 (n=66, 69, 67) | 8.6 percent predicted FEV1 | Standard Deviation 9.41 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 12 (n=65, 69, 65) | 9.5 percent predicted FEV1 | Standard Deviation 10.96 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 4 (n=68, 72, 75) | 4.0 percent predicted FEV1 | Standard Deviation 8.69 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 2 (n=76, 73, 77) | 1.4 percent predicted FEV1 | Standard Deviation 8.5 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 1 (n=78, 76, 81) | 1.0 percent predicted FEV1 | Standard Deviation 10.96 |
| Ciclesonide 100 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 6 (n=67, 72, 72) | 5.5 percent predicted FEV1 | Standard Deviation 10 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 1 (n=78, 76, 81) | 0.6 percent predicted FEV1 | Standard Deviation 9.67 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 8 (n=66, 71, 68) | 6.5 percent predicted FEV1 | Standard Deviation 12.25 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 10 (n=66, 69, 67) | 9.1 percent predicted FEV1 | Standard Deviation 10.48 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 2 (n=76, 73, 77) | 3.4 percent predicted FEV1 | Standard Deviation 9.6 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 4 (n=68, 72, 75) | 4.6 percent predicted FEV1 | Standard Deviation 9.31 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 12 (n=65, 69, 65) | 10.1 percent predicted FEV1 | Standard Deviation 11.29 |
| Ciclesonide 200 µg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 6 (n=67, 72, 72) | 7.2 percent predicted FEV1 | Standard Deviation 11.35 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 12 (n=65, 69, 65) | 10.4 percent predicted FEV1 | Standard Deviation 9.89 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 10 (n=66, 69, 67) | 8.7 percent predicted FEV1 | Standard Deviation 9.22 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 1 (n=78, 76, 81) | 1.0 percent predicted FEV1 | Standard Deviation 9.06 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 2 (n=76, 73, 77) | 0.3 percent predicted FEV1 | Standard Deviation 8.05 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 4 (n=68, 72, 75) | 5.1 percent predicted FEV1 | Standard Deviation 9.83 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 6 (n=67, 72, 72) | 4.9 percent predicted FEV1 | Standard Deviation 10.93 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) | Change at Month 8 (n=66, 71, 68) | 7.1 percent predicted FEV1 | Standard Deviation 10.24 |
Secondary
Change From Baseline in PEF by Diary Entries
PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. A positive change from Baseline indicates improvement.
Time frame: Baseline and Months 1, 2, 4, 6, 8, 10 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 8, Morning PEF (n=66, 71, 69) | 27.16 liters/second | Standard Deviation 32.53 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 10, Evening PEF (n=65, 70, 68) | 25.68 liters/second | Standard Deviation 30.945 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 2, Morning PEF (n=76, 72, 77) | 17.12 liters/second | Standard Deviation 32.068 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 10, Morning PEF (n=66, 70, 68) | 27.86 liters/second | Standard Deviation 38.406 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 12, Evening PEF (n=68, 71, 70) | 28.24 liters/second | Standard Deviation 28.811 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 12, Morning PEF (n=75, 73, 78) | 26.84 liters/second | Standard Deviation 32.932 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 4, Evening PEF (n=68, 72, 75) | 20.41 liters/second | Standard Deviation 22.058 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 1, Morning PEF (n=78, 76, 81) | 11.69 liters/second | Standard Deviation 21.268 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 4, Morning PEF (n=68, 71, 76) | 21.33 liters/second | Standard Deviation 26.603 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 6, Evening PEF (n=67, 72, 73) | 22.44 liters/second | Standard Deviation 28.236 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 1, Evening PEF (n=78, 76, 80) | 8.46 liters/second | Standard Deviation 17.952 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 6, Morning PEF (n=67, 72, 73) | 24.82 liters/second | Standard Deviation 30.613 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 2, Evening PEF (n=76, 71, 77) | 13.66 liters/second | Standard Deviation 28.491 |
| Ciclesonide 100 µg | Change From Baseline in PEF by Diary Entries | Change at Month 8, Evening PEF (n=66, 70, 69) | 25.47 liters/second | Standard Deviation 27.43 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 6, Morning PEF (n=67, 72, 73) | 24.68 liters/second | Standard Deviation 40.981 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 8, Morning PEF (n=66, 71, 69) | 23.76 liters/second | Standard Deviation 29.089 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 1, Evening PEF (n=78, 76, 80) | 8.54 liters/second | Standard Deviation 19.474 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 4, Evening PEF (n=68, 72, 75) | 16.01 liters/second | Standard Deviation 21.547 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 10, Evening PEF (n=65, 70, 68) | 26.78 liters/second | Standard Deviation 34.255 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 8, Evening PEF (n=66, 70, 69) | 21.38 liters/second | Standard Deviation 28.648 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 2, Evening PEF (n=76, 71, 77) | 13.04 liters/second | Standard Deviation 20.89 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 10, Morning PEF (n=66, 70, 68) | 29.84 liters/second | Standard Deviation 36.39 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 2, Morning PEF (n=76, 72, 77) | 14.30 liters/second | Standard Deviation 22.649 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 4, Morning PEF (n=68, 71, 76) | 18.24 liters/second | Standard Deviation 22.808 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 12, Evening PEF (n=68, 71, 70) | 33.35 liters/second | Standard Deviation 38.772 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 6, Evening PEF (n=67, 72, 73) | 21.86 liters/second | Standard Deviation 38.28 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 1, Morning PEF (n=78, 76, 81) | 10.82 liters/second | Standard Deviation 20.372 |
| Ciclesonide 200 µg | Change From Baseline in PEF by Diary Entries | Change at Month 12, Morning PEF (n=75, 73, 78) | 34.31 liters/second | Standard Deviation 41.166 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 6, Evening PEF (n=67, 72, 73) | 13.14 liters/second | Standard Deviation 33.321 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 1, Evening PEF (n=78, 76, 80) | 6.06 liters/second | Standard Deviation 39.183 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 1, Morning PEF (n=78, 76, 81) | 7.54 liters/second | Standard Deviation 25.697 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 2, Evening PEF (n=76, 71, 77) | 10.83 liters/second | Standard Deviation 40.563 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 2, Morning PEF (n=76, 72, 77) | 14.29 liters/second | Standard Deviation 37.228 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 4, Evening PEF (n=68, 72, 75) | 13.62 liters/second | Standard Deviation 37.99 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 4, Morning PEF (n=68, 71, 76) | 16.28 liters/second | Standard Deviation 34.841 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 12, Morning PEF (n=75, 73, 78) | 24.37 liters/second | Standard Deviation 39.312 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 6, Morning PEF (n=67, 72, 73) | 14.44 liters/second | Standard Deviation 29.95 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 8, Evening PEF (n=66, 70, 69) | 13.30 liters/second | Standard Deviation 37.061 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 8, Morning PEF (n=66, 71, 69) | 16.03 liters/second | Standard Deviation 34.017 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 10, Evening PEF (n=65, 70, 68) | 18.04 liters/second | Standard Deviation 38.209 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 10, Morning PEF (n=66, 70, 68) | 21.25 liters/second | Standard Deviation 34.94 |
| Placebo | Change From Baseline in PEF by Diary Entries | Change at Month 12, Evening PEF (n=68, 71, 70) | 25.38 liters/second | Standard Deviation 43.284 |
Secondary
Duration of Exacerbations
Duration of exacerbation was defined as the time in days when the criteria for an exacerbation were met to the time when peak flow measurements returned to baseline.
Time frame: Up to 12 months
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide 100 µg | Duration of Exacerbations | 9.17 days | Standard Deviation 6.198 |
| Ciclesonide 200 µg | Duration of Exacerbations | 9.31 days | Standard Deviation 7.65 |
| Placebo | Duration of Exacerbations | 7.92 days | Standard Deviation 4.061 |
Secondary
Growth Velocity as Assessed by Stadiometric Height Measurement
Standing height measured in millimeters (mm) with a wall-mounted stadiometer.
Time frame: Up to 12 months
Population: Safety analysis set included all randomized participants who received at least 1 dose of trial medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide 100 µg | Growth Velocity as Assessed by Stadiometric Height Measurement | 55.32 mm/year | Standard Deviation 25.81 |
| Ciclesonide 200 µg | Growth Velocity as Assessed by Stadiometric Height Measurement | 64.60 mm/year | Standard Deviation 27.31 |
| Placebo | Growth Velocity as Assessed by Stadiometric Height Measurement | 54.91 mm/year | Standard Deviation 21.78 |
Secondary
Mean Rate of Asthma Exacerbations Per Year
Rate of asthma exacerbations per year is equal to total number of asthma exacerbations during treatment/time on treatment (year).
Time frame: Up to 12 months
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide 100 µg | Mean Rate of Asthma Exacerbations Per Year | 0.88 number of exacerbations per year | Standard Deviation 1.366 |
| Ciclesonide 200 µg | Mean Rate of Asthma Exacerbations Per Year | 0.85 number of exacerbations per year | Standard Deviation 1.31 |
| Placebo | Mean Rate of Asthma Exacerbations Per Year | 3.28 number of exacerbations per year | Standard Deviation 19.874 |
p-value: 0.4754Kruskal-Wallis
p-value: 0.6844Kruskal-Wallis
Secondary
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries
PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF.
Time frame: Months 1, 2, 4, 6, 8, 10 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 2, Evening PEF (n=76, 71, 77) | 241.07 liters/second | Standard Deviation 58.604 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 4, Morning PEF (n=68, 71, 76) | 242.93 liters/second | Standard Deviation 56.658 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 4, Evening PEF (n=68, 72, 75) | 249.75 liters/second | Standard Deviation 58.528 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 8, Evening PEF (n=66, 70, 69) | 253.49 liters/second | Standard Deviation 59.666 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 6, Evening PEF (n=67, 72, 73) | 251.88 liters/second | Standard Deviation 60.255 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 2, Morning PEF (n=76, 72, 77) | 236.92 liters/second | Standard Deviation 61.243 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 6, Morning PEF (n=67, 72, 73) | 246.44 liters/second | Standard Deviation 59.781 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 10, Morning PEF (n=66, 70, 68) | 247.94 liters/second | Standard Deviation 60.418 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 1, Evening PEF (n=78, 76, 80) | 235.72 liters/second | Standard Deviation 63.882 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 12, Morning PEF (n=75, 73, 78) | 245.84 liters/second | Standard Deviation 59.834 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 10, Evening PEF (n=65, 70, 68) | 254.21 liters/second | Standard Deviation 56.815 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 1, Morning PEF (n=78, 76, 81) | 232.09 liters/second | Standard Deviation 64.933 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 12, Evening PEF (n=68, 71, 70) | 255.97 liters/second | Standard Deviation 57.291 |
| Ciclesonide 100 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 8, Morning PEF (n=66, 71, 69) | 247.24 liters/second | Standard Deviation 59.806 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 10, Evening PEF (n=65, 70, 68) | 256.44 liters/second | Standard Deviation 56.469 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 2, Morning PEF (n=76, 72, 77) | 236.42 liters/second | Standard Deviation 52.323 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 4, Evening PEF (n=68, 72, 75) | 243.52 liters/second | Standard Deviation 49.076 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 1, Evening PEF (n=78, 76, 80) | 238.16 liters/second | Standard Deviation 52.565 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 1, Morning PEF (n=78, 76, 81) | 234.41 liters/second | Standard Deviation 52.908 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 4, Morning PEF (n=68, 71, 76) | 241.91 liters/second | Standard Deviation 48.498 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 6, Evening PEF (n=67, 72, 73) | 249.36 liters/second | Standard Deviation 59.294 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 6, Morning PEF (n=67, 72, 73) | 246.75 liters/second | Standard Deviation 60.02 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 8, Evening PEF (n=66, 70, 69) | 250.92 liters/second | Standard Deviation 51.376 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 8, Morning PEF (n=66, 71, 69) | 246.97 liters/second | Standard Deviation 51.592 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 2, Evening PEF (n=76, 71, 77) | 241.16 liters/second | Standard Deviation 50.422 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 10, Morning PEF (n=66, 70, 68) | 254.04 liters/second | Standard Deviation 56.719 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 12, Evening PEF (n=68, 71, 70) | 263.87 liters/second | Standard Deviation 58.469 |
| Ciclesonide 200 µg | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 12, Morning PEF (n=75, 73, 78) | 258.62 liters/second | Standard Deviation 57.009 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 12, Morning PEF (n=75, 73, 78) | 250.55 liters/second | Standard Deviation 63.204 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 8, Morning PEF (n=66, 71, 69) | 239.73 liters/second | Standard Deviation 61.733 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 1, Evening PEF (n=78, 76, 80) | 241.89 liters/second | Standard Deviation 70.619 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 12, Evening PEF (n=68, 71, 70) | 261.88 liters/second | Standard Deviation 61.383 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 10, Evening PEF (n=65, 70, 68) | 251.69 liters/second | Standard Deviation 60.704 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 4, Evening PEF (n=68, 72, 75) | 245.91 liters/second | Standard Deviation 65.802 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 2, Evening PEF (n=76, 71, 77) | 244.67 liters/second | Standard Deviation 67.846 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 6, Evening PEF (n=67, 72, 73) | 246.44 liters/second | Standard Deviation 63.946 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 10, Morning PEF (n=66, 70, 68) | 246.23 liters/second | Standard Deviation 62.805 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 6, Morning PEF (n=67, 72, 73) | 238.81 liters/second | Standard Deviation 63.419 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 4, Morning PEF (n=68, 71, 76) | 240.16 liters/second | Standard Deviation 65.211 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 2, Morning PEF (n=76, 72, 77) | 239.07 liters/second | Standard Deviation 70.132 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 8, Evening PEF (n=66, 70, 69) | 245.72 liters/second | Standard Deviation 61.399 |
| Placebo | Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries | Month 1, Morning PEF (n=78, 76, 81) | 233.81 liters/second | Standard Deviation 66.039 |
Secondary
Number of Exacerbations Per Participant
The mean number of asthma exacerbations per participant is reported.
Time frame: Up to 12 months
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide 100 µg | Number of Exacerbations Per Participant | 0.72 exacerbations | Standard Deviation 1.025 |
| Ciclesonide 200 µg | Number of Exacerbations Per Participant | 0.78 exacerbations | Standard Deviation 1.028 |
| Placebo | Number of Exacerbations Per Participant | 0.95 exacerbations | Standard Deviation 1.316 |
Secondary
Number of Participants With Adverse Events and Serious Adverse Events
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect or any other important medical condition considered serious based on medical and scientific judgement.
Time frame: Up to 12 months
Population: Safety analysis set included all randomized participants who received at least 1 dose of trial medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide 100 µg | Number of Participants With Adverse Events and Serious Adverse Events | Adverse Events | 61 participants |
| Ciclesonide 100 µg | Number of Participants With Adverse Events and Serious Adverse Events | Serious Adverse Events | 2 participants |
| Ciclesonide 200 µg | Number of Participants With Adverse Events and Serious Adverse Events | Adverse Events | 64 participants |
| Ciclesonide 200 µg | Number of Participants With Adverse Events and Serious Adverse Events | Serious Adverse Events | 2 participants |
| Placebo | Number of Participants With Adverse Events and Serious Adverse Events | Adverse Events | 63 participants |
| Placebo | Number of Participants With Adverse Events and Serious Adverse Events | Serious Adverse Events | 2 participants |
Secondary
Number of Participants With Clinically Significant Laboratory Values
Clinically significant laboratory values were hematology and chemistry tests determined by the investigator to be clinically significant based on the following criteria: Hemoglobin \<9.5 g/dL; Erythrocytes \<3.0 x 10\^6/μL or \>6.5 x 10\^6/μL; White Blood Count \<3000/mm\^3 or \>20000/mm\^3; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transpeptidase (GGT), Total Bilirubin and Glucose \>2 times Upper limit of Normal Range (ULNR); Alkaline Phosphatase and Creatine Kinase \>3 times ULNR; Creatinine \>1.5 times ULN; Potassium \>5.0 mmol/L or \<3.0 mmol/L; and Sodium \>150 mmol/L or 130 mmol/L.
Time frame: Up to 12 months
Population: Safety analysis set included all randomized participants who received at least 1 dose of trial medication.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ciclesonide 100 µg | Number of Participants With Clinically Significant Laboratory Values | 0 participants | 0 |
| Ciclesonide 200 µg | Number of Participants With Clinically Significant Laboratory Values | 0 participants | 0 |
| Placebo | Number of Participants With Clinically Significant Laboratory Values | 0 participants | 0 |
Secondary
Number of Participants With Clinically Significant Physical Examination Findings
A thorough physical examination was performed consisting of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) lungs/thorax; (4) heart/cardiovascular system; (5) abdomen; (6) skin and mucosae; (7) nervous system; (8) lymph nodes; (9) musculo-skeletal system; (10) physical examinations other than body systems described in (1) to (9). The investigator determined if any of the findings were clinically significant.
Time frame: Up to 12 months
Population: Safety analysis set included all randomized participants who received at least 1 dose of trial medication.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ciclesonide 100 µg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants | 0 |
| Ciclesonide 200 µg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants | 0 |
| Placebo | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants | 0 |
Secondary
Number of Participants With Clinically Significant Vital Signs Findings
Vital signs included body temperature, systolic and diastolic blood pressure and heart rate in beats per minute (bpm). The investigator determined if the result was clinically significant based on the following criteria: Systolic Blood Pressure \>130 mmHg or \<80 mmHg or a \>20 mmHg difference from Baseline; Diastolic Blood Pressure \> 85 mmHg; and Resting Heart Rate \>140 bpm or \<60 bpm or a \>30 bpm difference from Baseline.
Time frame: Up to 12 months
Population: Safety analysis set included all randomized participants who received at least 1 dose of trial medication.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Ciclesonide 100 µg | Number of Participants With Clinically Significant Vital Signs Findings | 0 participants | 0 |
| Ciclesonide 200 µg | Number of Participants With Clinically Significant Vital Signs Findings | 0 participants | 0 |
| Placebo | Number of Participants With Clinically Significant Vital Signs Findings | 0 participants | 0 |
Secondary
Percentage of Asthma Symptom Free Days
Days without Asthma Symptom documented in the participant's diary were reported.
Time frame: Months 1, 2, 4, 6, 8, 10 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Percentage of Asthma Symptom Free Days | Month 4 (n=54,55, 59) | 42.57 percentage of days | Standard Deviation 46.573 |
| Ciclesonide 100 µg | Percentage of Asthma Symptom Free Days | Month 12 (n=42, 44, 45) | 43.20 percentage of days | Standard Deviation 46.787 |
| Ciclesonide 100 µg | Percentage of Asthma Symptom Free Days | Month 8 (n=46, 46, 46) | 38.86 percentage of days | Standard Deviation 43.312 |
| Ciclesonide 100 µg | Percentage of Asthma Symptom Free Days | Month 6 (n=53, 50, 51) | 41.75 percentage of days | Standard Deviation 46.474 |
| Ciclesonide 100 µg | Percentage of Asthma Symptom Free Days | Month 2 (n=61, 50, 56) | 38.47 percentage of days | Standard Deviation 44.743 |
| Ciclesonide 100 µg | Percentage of Asthma Symptom Free Days | Month 1 (n=62, 60, 60) | 37.32 percentage of days | Standard Deviation 40.983 |
| Ciclesonide 100 µg | Percentage of Asthma Symptom Free Days | Month 10 (n=43, 47, 44) | 41.00 percentage of days | Standard Deviation 46.575 |
| Ciclesonide 200 µg | Percentage of Asthma Symptom Free Days | Month 12 (n=42, 44, 45) | 42.03 percentage of days | Standard Deviation 47.093 |
| Ciclesonide 200 µg | Percentage of Asthma Symptom Free Days | Month 1 (n=62, 60, 60) | 36.95 percentage of days | Standard Deviation 42.207 |
| Ciclesonide 200 µg | Percentage of Asthma Symptom Free Days | Month 2 (n=61, 50, 56) | 41.16 percentage of days | Standard Deviation 44.738 |
| Ciclesonide 200 µg | Percentage of Asthma Symptom Free Days | Month 4 (n=54,55, 59) | 38.83 percentage of days | Standard Deviation 44.042 |
| Ciclesonide 200 µg | Percentage of Asthma Symptom Free Days | Month 6 (n=53, 50, 51) | 39.87 percentage of days | Standard Deviation 43.744 |
| Ciclesonide 200 µg | Percentage of Asthma Symptom Free Days | Month 8 (n=46, 46, 46) | 43.90 percentage of days | Standard Deviation 45.377 |
| Ciclesonide 200 µg | Percentage of Asthma Symptom Free Days | Month 10 (n=43, 47, 44) | 41.65 percentage of days | Standard Deviation 47.435 |
| Placebo | Percentage of Asthma Symptom Free Days | Month 1 (n=62, 60, 60) | 35.00 percentage of days | Standard Deviation 43.032 |
| Placebo | Percentage of Asthma Symptom Free Days | Month 8 (n=46, 46, 46) | 40.03 percentage of days | Standard Deviation 43.369 |
| Placebo | Percentage of Asthma Symptom Free Days | Month 2 (n=61, 50, 56) | 33.56 percentage of days | Standard Deviation 44.161 |
| Placebo | Percentage of Asthma Symptom Free Days | Month 12 (n=42, 44, 45) | 44.61 percentage of days | Standard Deviation 46.12 |
| Placebo | Percentage of Asthma Symptom Free Days | Month 10 (n=43, 47, 44) | 39.83 percentage of days | Standard Deviation 44.332 |
| Placebo | Percentage of Asthma Symptom Free Days | Month 6 (n=53, 50, 51) | 40.09 percentage of days | Standard Deviation 45.274 |
| Placebo | Percentage of Asthma Symptom Free Days | Month 4 (n=54,55, 59) | 35.78 percentage of days | Standard Deviation 43.538 |
Secondary
Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms
Nocturnal awakenings due to asthma symptoms were recorded in the participant's diary.
Time frame: Months 1, 2, 4, 6, 8, 10 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 2 (n=76, 73, 77) | 1.96 percentage of nights | Standard Deviation 5.877 |
| Ciclesonide 100 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 8 (n=66, 70, 69) | 1.62 percentage of nights | Standard Deviation 4.129 |
| Ciclesonide 100 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 6 (n=67, 72, 73) | 0.87 percentage of nights | Standard Deviation 2.527 |
| Ciclesonide 100 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 1 (n=78, 75, 80) | 2.40 percentage of nights | Standard Deviation 6.159 |
| Ciclesonide 100 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 12 (n=74, 73, 78) | 0.41 percentage of nights | Standard Deviation 1.554 |
| Ciclesonide 100 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 10 (n=66, 70, 68) | 1.93 percentage of nights | Standard Deviation 7.106 |
| Ciclesonide 100 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 4 (n=68, 72, 75) | 1.33 percentage of nights | Standard Deviation 4.017 |
| Ciclesonide 200 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 6 (n=67, 72, 73) | 1.51 percentage of nights | Standard Deviation 3.288 |
| Ciclesonide 200 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 1 (n=78, 75, 80) | 1.64 percentage of nights | Standard Deviation 4.256 |
| Ciclesonide 200 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 2 (n=76, 73, 77) | 0.62 percentage of nights | Standard Deviation 2.364 |
| Ciclesonide 200 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 4 (n=68, 72, 75) | 0.86 percentage of nights | Standard Deviation 2.139 |
| Ciclesonide 200 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 8 (n=66, 70, 69) | 1.05 percentage of nights | Standard Deviation 2.823 |
| Ciclesonide 200 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 10 (n=66, 70, 68) | 0.59 percentage of nights | Standard Deviation 2.22 |
| Ciclesonide 200 µg | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 12 (n=74, 73, 78) | 1.84 percentage of nights | Standard Deviation 11.769 |
| Placebo | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 8 (n=66, 70, 69) | 1.82 percentage of nights | Standard Deviation 5.024 |
| Placebo | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 2 (n=76, 73, 77) | 1.73 percentage of nights | Standard Deviation 4.662 |
| Placebo | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 12 (n=74, 73, 78) | 0.53 percentage of nights | Standard Deviation 1.853 |
| Placebo | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 10 (n=66, 70, 68) | 1.88 percentage of nights | Standard Deviation 5.468 |
| Placebo | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 6 (n=67, 72, 73) | 1.26 percentage of nights | Standard Deviation 3.235 |
| Placebo | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 4 (n=68, 72, 75) | 1.54 percentage of nights | Standard Deviation 4.106 |
| Placebo | Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms | Month 1 (n=78, 75, 80) | 1.85 percentage of nights | Standard Deviation 4.223 |
Secondary
Percentage of Participants Who Dropped-out Due to Asthma Exacerbation
Time frame: Up to 12 months
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide 100 µg | Percentage of Participants Who Dropped-out Due to Asthma Exacerbation | 1.3 percentage of participants |
| Ciclesonide 200 µg | Percentage of Participants Who Dropped-out Due to Asthma Exacerbation | 1.3 percentage of participants |
| Placebo | Percentage of Participants Who Dropped-out Due to Asthma Exacerbation | 4.8 percentage of participants |
Secondary
Percentage of Rescue Medication Free Days
Days without use of rescue medication documented in the participant's diary were reported.
Time frame: Months 1, 2, 4, 6, 8, 10 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Percentage of Rescue Medication Free Days | Month 8 (n=39, 42, 44) | 47.93 percentage of days | Standard Deviation 45.17 |
| Ciclesonide 100 µg | Percentage of Rescue Medication Free Days | Month 2 (n=52, 41, 48) | 48.78 percentage of days | Standard Deviation 46.442 |
| Ciclesonide 100 µg | Percentage of Rescue Medication Free Days | Month 10 (n=40, 40, 37) | 46.22 percentage of days | Standard Deviation 47.901 |
| Ciclesonide 100 µg | Percentage of Rescue Medication Free Days | Month 1 (n=55, 53, 54) | 47.94 percentage of days | Standard Deviation 44.405 |
| Ciclesonide 100 µg | Percentage of Rescue Medication Free Days | Month 12 (n=35, 41, 40) | 53.58 percentage of days | Standard Deviation 47.785 |
| Ciclesonide 100 µg | Percentage of Rescue Medication Free Days | Month 4 (n=49, 48, 52) | 49.91 percentage of days | Standard Deviation 48.274 |
| Ciclesonide 100 µg | Percentage of Rescue Medication Free Days | Month 6 (n=47, 44, 45) | 49.63 percentage of days | Standard Deviation 48.084 |
| Ciclesonide 200 µg | Percentage of Rescue Medication Free Days | Month 1 (n=55, 53, 54) | 47.34 percentage of days | Standard Deviation 44.984 |
| Ciclesonide 200 µg | Percentage of Rescue Medication Free Days | Month 8 (n=39, 42, 44) | 50.50 percentage of days | Standard Deviation 46.1 |
| Ciclesonide 200 µg | Percentage of Rescue Medication Free Days | Month 6 (n=47, 44, 45) | 48.14 percentage of days | Standard Deviation 45.321 |
| Ciclesonide 200 µg | Percentage of Rescue Medication Free Days | Month 4 (n=49, 48, 52) | 46.51 percentage of days | Standard Deviation 45.209 |
| Ciclesonide 200 µg | Percentage of Rescue Medication Free Days | Month 10 (n=40, 40, 37) | 49.78 percentage of days | Standard Deviation 48.521 |
| Ciclesonide 200 µg | Percentage of Rescue Medication Free Days | Month 2 (n=52, 41, 48) | 54.46 percentage of days | Standard Deviation 46.668 |
| Ciclesonide 200 µg | Percentage of Rescue Medication Free Days | Month 12 (n=35, 41, 40) | 53.63 percentage of days | Standard Deviation 48.358 |
| Placebo | Percentage of Rescue Medication Free Days | Month 12 (n=35, 41, 40) | 58.03 percentage of days | Standard Deviation 46.264 |
| Placebo | Percentage of Rescue Medication Free Days | Month 1 (n=55, 53, 54) | 44.37 percentage of days | Standard Deviation 45.367 |
| Placebo | Percentage of Rescue Medication Free Days | Month 2 (n=52, 41, 48) | 45.31 percentage of days | Standard Deviation 47.761 |
| Placebo | Percentage of Rescue Medication Free Days | Month 4 (n=49, 48, 52) | 45.91 percentage of days | Standard Deviation 46.328 |
| Placebo | Percentage of Rescue Medication Free Days | Month 6 (n=47, 44, 45) | 49.42 percentage of days | Standard Deviation 47.515 |
| Placebo | Percentage of Rescue Medication Free Days | Month 8 (n=39, 42, 44) | 45.22 percentage of days | Standard Deviation 45.002 |
| Placebo | Percentage of Rescue Medication Free Days | Month 10 (n=40, 40, 37) | 52.70 percentage of days | Standard Deviation 46.015 |
Secondary
Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
The PACQLQ consists of 13 items divided into two domains: Activity limitations (items 2, 4, 6, 8) and Emotional function (items 1, 3, 5, 7, 9, 10, 11, 12, 13). Caregivers answered each question using a seven-point scale (whereby 1 indicated maximum impairment and 7 indicated no impairment) and recalled their experiences during the previous week. Overall PACQLQ score is equal to the mean of all 13 items for a total possible score of 1 (worst) to 7 (best).
Time frame: Months 2, 6 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | Month 12 (n=66, 69, 66) | 6.32 score on a scale | Standard Deviation 0.849 |
| Ciclesonide 100 µg | Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | Month 6 (n=67, 72, 73) | 6.15 score on a scale | Standard Deviation 1.005 |
| Ciclesonide 100 µg | Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | Month 2 (n=73, 73, 76) | 5.87 score on a scale | Standard Deviation 1.196 |
| Ciclesonide 200 µg | Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | Month 6 (n=67, 72, 73) | 6.16 score on a scale | Standard Deviation 1.115 |
| Ciclesonide 200 µg | Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | Month 2 (n=73, 73, 76) | 6.16 score on a scale | Standard Deviation 1.033 |
| Ciclesonide 200 µg | Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | Month 12 (n=66, 69, 66) | 6.25 score on a scale | Standard Deviation 0.712 |
| Placebo | Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | Month 2 (n=73, 73, 76) | 6.08 score on a scale | Standard Deviation 1.078 |
| Placebo | Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | Month 12 (n=66, 69, 66) | 6.31 score on a scale | Standard Deviation 0.899 |
| Placebo | Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | Month 6 (n=67, 72, 73) | 6.31 score on a scale | Standard Deviation 0.927 |
Secondary
Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])
The PAQLQ(S) consists of 23 items divided into three domains: Activity limitations (items 1-3, 19, 22); Symptoms (items 4, 6, 8, 10, 12, 14, 16, 18, 20, 23) and Emotional function (items 5, 7, 9, 11, 13, 15, 17, 21). Participants were asked to answer each question using a seven-point scale (where 1 indicated maximum impairment and 7 indicated no impairment) and recall their experience during the previous week. Overall PAQLQ score is equal to the mean of all 23 items for a total possible score 1 (worst) to 7 (best).
Time frame: Months 2, 6 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) | Month 6 (n=65, 72, 72) | 6.33 score on a scale | Standard Deviation 0.874 |
| Ciclesonide 100 µg | Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) | Month 12 (n=64, 69, 65) | 6.42 score on a scale | Standard Deviation 0.786 |
| Ciclesonide 100 µg | Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) | Month 2 (n=70, 73, 75) | 6.21 score on a scale | Standard Deviation 0.979 |
| Ciclesonide 200 µg | Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) | Month 12 (n=64, 69, 65) | 6.34 score on a scale | Standard Deviation 0.946 |
| Ciclesonide 200 µg | Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) | Month 2 (n=70, 73, 75) | 6.27 score on a scale | Standard Deviation 0.878 |
| Ciclesonide 200 µg | Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) | Month 6 (n=65, 72, 72) | 6.26 score on a scale | Standard Deviation 0.982 |
| Placebo | Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) | Month 6 (n=65, 72, 72) | 6.30 score on a scale | Standard Deviation 0.933 |
| Placebo | Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) | Month 2 (n=70, 73, 75) | 6.08 score on a scale | Standard Deviation 1.031 |
| Placebo | Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) | Month 12 (n=64, 69, 65) | 6.36 score on a scale | Standard Deviation 0.824 |
Secondary
Rescue Medication Use Per Day
Salbutamol (100 μg/puff) was used as rescue medication according to the individual needs of the participant. Each use was documented in the participant's diary.
Time frame: Months 1, 2, 4, 6, 8, 10 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Rescue Medication Use Per Day | Month 1 (n=57, 51, 54) | 1.00 puffs/day | Standard Deviation 1.345 |
| Ciclesonide 100 µg | Rescue Medication Use Per Day | Month 8 (n=38, 42, 45) | 1.01 puffs/day | Standard Deviation 1.53 |
| Ciclesonide 100 µg | Rescue Medication Use Per Day | Month 10 (n=38, 41, 39) | 0.93 puffs/day | Standard Deviation 1.423 |
| Ciclesonide 100 µg | Rescue Medication Use Per Day | Month 6 (n=45, 43, 44) | 0.79 puffs/day | Standard Deviation 1.084 |
| Ciclesonide 100 µg | Rescue Medication Use Per Day | Month 12 (n=36, 40, 40) | 0.71 puffs/day | Standard Deviation 0.897 |
| Ciclesonide 100 µg | Rescue Medication Use Per Day | Month 2 (n=53, 40, 46) | 0.99 puffs/day | Standard Deviation 1.296 |
| Ciclesonide 100 µg | Rescue Medication Use Per Day | Month 4 (n=48, 47, 51) | 0.88 puffs/day | Standard Deviation 1.3 |
| Ciclesonide 200 µg | Rescue Medication Use Per Day | Month 6 (n=45, 43, 44) | 1.07 puffs/day | Standard Deviation 1.329 |
| Ciclesonide 200 µg | Rescue Medication Use Per Day | Month 4 (n=48, 47, 51) | 1.18 puffs/day | Standard Deviation 1.595 |
| Ciclesonide 200 µg | Rescue Medication Use Per Day | Month 8 (n=38, 42, 45) | 1.13 puffs/day | Standard Deviation 1.95 |
| Ciclesonide 200 µg | Rescue Medication Use Per Day | Month 1 (n=57, 51, 54) | 0.83 puffs/day | Standard Deviation 1.148 |
| Ciclesonide 200 µg | Rescue Medication Use Per Day | Month 2 (n=53, 40, 46) | 0.53 puffs/day | Standard Deviation 0.728 |
| Ciclesonide 200 µg | Rescue Medication Use Per Day | Month 10 (n=38, 41, 39) | 0.95 puffs/day | Standard Deviation 1.243 |
| Ciclesonide 200 µg | Rescue Medication Use Per Day | Month 12 (n=36, 40, 40) | 1.01 puffs/day | Standard Deviation 1.36 |
| Placebo | Rescue Medication Use Per Day | Month 10 (n=38, 41, 39) | 0.83 puffs/day | Standard Deviation 1.113 |
| Placebo | Rescue Medication Use Per Day | Month 12 (n=36, 40, 40) | 0.75 puffs/day | Standard Deviation 1.152 |
| Placebo | Rescue Medication Use Per Day | Month 1 (n=57, 51, 54) | 0.87 puffs/day | Standard Deviation 0.91 |
| Placebo | Rescue Medication Use Per Day | Month 2 (n=53, 40, 46) | 0.97 puffs/day | Standard Deviation 1.298 |
| Placebo | Rescue Medication Use Per Day | Month 4 (n=48, 47, 51) | 1.27 puffs/day | Standard Deviation 1.984 |
| Placebo | Rescue Medication Use Per Day | Month 6 (n=45, 43, 44) | 0.92 puffs/day | Standard Deviation 1.583 |
| Placebo | Rescue Medication Use Per Day | Month 8 (n=38, 42, 45) | 0.97 puffs/day | Standard Deviation 1.219 |
Secondary
Total Asthma Symptom Score by Diary Entries
Total Asthma Score = daytime asthma score + night-time asthma score, where higher score indicates worsening of disease. Night-time asthma score is assessed on a 5 point scale where 0=No symptoms, slept through the night, 1=Slept well but some complaints in the morning, 2=Woke up once because of asthma (including early wakening), 3=Woke up several times because of asthma (including early wakening) and 4=Bad night, awake most of the night because of asthma. Day-time asthma score is assessed on a 5 point scale where 0= Very well, no symptoms, 1= One episode of wheezing, cough or breathlessness, 2= More than one episode of wheezing, cough or breathlessness without interfering with normal activities, 3= Wheezing, cough or shortness of breath most of the day which interfered to some extent with normal activities and 4= Asthma very bad. Unable to carry out daily activities as usual.
Time frame: Months 1, 2, 4, 6, 8, 10 and 12
Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide 100 µg | Total Asthma Symptom Score by Diary Entries | Month 4 (n=68, 72, 75) | 0.18 score on a scale | Standard Deviation 0.342 |
| Ciclesonide 100 µg | Total Asthma Symptom Score by Diary Entries | Month 2 (n=76, 70, 77) | 0.26 score on a scale | Standard Deviation 0.424 |
| Ciclesonide 100 µg | Total Asthma Symptom Score by Diary Entries | Month 8 (n=66, 69, 69) | 0.17 score on a scale | Standard Deviation 0.283 |
| Ciclesonide 100 µg | Total Asthma Symptom Score by Diary Entries | Month 6 (n=67, 72, 73) | 0.16 score on a scale | Standard Deviation 0.289 |
| Ciclesonide 100 µg | Total Asthma Symptom Score by Diary Entries | Month 10 (n=64, 70, 68) | 0.12 score on a scale | Standard Deviation 0.253 |
| Ciclesonide 100 µg | Total Asthma Symptom Score by Diary Entries | Month 1 (n=77, 75, 79) | 0.37 score on a scale | Standard Deviation 0.489 |
| Ciclesonide 100 µg | Total Asthma Symptom Score by Diary Entries | Month 12 (n=68, 69, 70) | 0.11 score on a scale | Standard Deviation 0.24 |
| Ciclesonide 200 µg | Total Asthma Symptom Score by Diary Entries | Month 2 (n=76, 70, 77) | 0.14 score on a scale | Standard Deviation 0.246 |
| Ciclesonide 200 µg | Total Asthma Symptom Score by Diary Entries | Month 1 (n=77, 75, 79) | 0.22 score on a scale | Standard Deviation 0.329 |
| Ciclesonide 200 µg | Total Asthma Symptom Score by Diary Entries | Month 4 (n=68, 72, 75) | 0.12 score on a scale | Standard Deviation 0.178 |
| Ciclesonide 200 µg | Total Asthma Symptom Score by Diary Entries | Month 6 (n=67, 72, 73) | 0.17 score on a scale | Standard Deviation 0.294 |
| Ciclesonide 200 µg | Total Asthma Symptom Score by Diary Entries | Month 8 (n=66, 69, 69) | 0.13 score on a scale | Standard Deviation 0.243 |
| Ciclesonide 200 µg | Total Asthma Symptom Score by Diary Entries | Month 10 (n=64, 70, 68) | 0.11 score on a scale | Standard Deviation 0.227 |
| Ciclesonide 200 µg | Total Asthma Symptom Score by Diary Entries | Month 12 (n=68, 69, 70) | 0.08 score on a scale | Standard Deviation 0.129 |
| Placebo | Total Asthma Symptom Score by Diary Entries | Month 2 (n=76, 70, 77) | 0.28 score on a scale | Standard Deviation 0.484 |
| Placebo | Total Asthma Symptom Score by Diary Entries | Month 8 (n=66, 69, 69) | 0.23 score on a scale | Standard Deviation 0.414 |
| Placebo | Total Asthma Symptom Score by Diary Entries | Month 1 (n=77, 75, 79) | 0.32 score on a scale | Standard Deviation 0.535 |
| Placebo | Total Asthma Symptom Score by Diary Entries | Month 12 (n=68, 69, 70) | 0.15 score on a scale | Standard Deviation 0.338 |
| Placebo | Total Asthma Symptom Score by Diary Entries | Month 6 (n=67, 72, 73) | 0.18 score on a scale | Standard Deviation 0.289 |
| Placebo | Total Asthma Symptom Score by Diary Entries | Month 10 (n=64, 70, 68) | 0.24 score on a scale | Standard Deviation 0.49 |
| Placebo | Total Asthma Symptom Score by Diary Entries | Month 4 (n=68, 72, 75) | 0.24 score on a scale | Standard Deviation 0.359 |