| Primary | Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population | PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 4 participants from prednisone group had the missing outcome measure. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, centre and treatment group. | ITT Population comprised of all participants randomized to treatment and who received at least one dose of study drug. Data is presented for the participants available at the time of assessment. | Posted | | Least Squares Mean | Standard Error | Litres per minute (L/min) | | Days 2 to 8 | | | | ID | Title | Description |
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| OG000 | Fluticasone Propionate | Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. | | OG001 | Prednisone | Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000188.77± 3.774
- OG001188.31± 3.790
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 250 par were to be enrolled to achieve 200 total evaluable par or 100 evaluable par per group. Sample size was based on the primary efficacy endpoint (AM PEF) and had 80% power to reject the null hypothesis: nebulized FP (1 mg BID) was inferior to oral prednisone with regard to AM PEF using one-side t test at significance level 2.5%, and assuming true treatment difference (FP minus predisone) was 3.6 L/min, noninferiority margin was -12L/min, and common standard deviation was 39 L/min. | ANCOVA | | 0.931 | | Mean Difference (Final Values) | 0.46 | | | 2-Sided | 95 | -9.85 | 10.76 | | | | | Non-Inferiority or Equivalence | |
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| Primary | Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population | PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before talking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using ANCOVA model with effects due to gender, age ,centre and treatment group. | PP Population comprised of all participants in the ITT Population who did not have any full protocol violations which could impact treatment effect. Data is presented for the participants available at the time of assessment. | Posted | | Least Squares Mean | Standard Error | L/min | | Days 2 to 8 | | | | ID | Title | Description |
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| OG000 | Fluticasone Propionate | Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. | | OG001 | Prednisone |
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| Secondary | Mean Evening PEF on Diary Card Over the Treatment Assessment Period | PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00 post meridiem [PM]) before taking any study drug. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If participants started to take the study drug in the morning (early or on 12:00 PM), only then the evening PEF on the date of randomization was used. The outcome measure was considered missing if less than 2 days was recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using an ANCOVA model with effects due to gender, age, centre and treatment group. | ITT Population. Data is presented for the participants available at the time of assessment. | Posted | | Least Squares Mean | Standard Error | L/min | | Days 1/2 to 8 | | | | ID | Title | Description |
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| OG000 | Fluticasone Propionate | Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. | | OG001 | Prednisone |
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| Secondary | Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period | The symptoms of cough, sputum production, wheeze and dyspnoea were assessed in morning and evening, and recorded on participant diary cards. Day-time symptoms were scored while retiring to bed on a scale of 0 (no symptoms) to 5 (severe). Night-time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). For day-time score, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. For night-time score, only data that are from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. The analysis only includes participants with at least 2 days of non-missing symptom scores in the given treatment assessment period. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | | Median | Full Range | Scores on a scale | | Days 2 to 8 | | | | ID | Title | Description |
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| OG000 | Fluticasone Propionate | Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. | | OG001 | Prednisone | |
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| Secondary | Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period | The use of nebulized salbutamol (doses/puffs and frequency) were recorded on diary card in the morning and evening. The median numbers of times of use of rescue medication during day and night was calculated for each participant over the treatment assessment period. In each case, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. The outcome measure was considered missing if less than 2 days (that is., 24-hour periods) were recorded in the given treatment assessment period. The analysis only includes participants who have at least 2 days of non-missing numbers of times rescue medication (including zero) in the given treatment assessment period. | ITT Population. Data is presented for the participants available at the time of assessment. | Posted | | Median | Full Range | Number of use of rescue medication | | Days 2 to 8 | | | | ID | Title | Description |
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| OG000 | Fluticasone Propionate | Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. | | OG001 | Prednisone | Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. |
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| Secondary | Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period | Spirometric assessments of FEV1 and FVC were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was performed using ANCOVA with covariates of gender, centre, age and treatment. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | Litres | | During the treatment period at Day 5, Day 8 | | | | ID | Title | Description |
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| OG000 | Fluticasone Propionate | Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. | | OG001 | Prednisone | Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. |
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| Secondary | Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8 | The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represented the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters were scored on a 4-point scale of 0 to 3 where 0=none, 1=mild, 2=moderate and 3=severe. The total score ranged from 0 to 12, where 0 indicated absence of symptoms and 12 indicated most severe symptoms. The Baseline value was the last non-missing value prior to randomization. Change from Baseline was calculated/defined as value at the indicated visit minus value at the Baseline. A negative value of change in score from Baseline indicated improvement in severity of symptoms. If participants discontinued before or on Day 5, then the clinical scoring index collected at the early withdrawal visit was included in the Visit 2. Otherwise, the clinical scoring index collected at the early withdrawal visit was included in the Visit 3 | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline, Day 5 and Day 8 | | | | ID | Title | Description |
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| OG000 | Fluticasone Propionate | Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. | | OG001 |
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| Secondary | Mean Global Evaluation for Efficacy by Participant/Parent and Investigator | At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Day 8 | | | | ID | Title | Description |
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| OG000 | Fluticasone Propionate | Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. | | OG001 | Prednisone | Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. |
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