E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the efficacy and safety of nebulized fluticasone propionated 1mg BID compared with oral prednisone administered for 7 days to Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbatio of asthma. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Chinese male and female pediatric or adolescent subjects aged 4 to 16 years, inclusive
- Subjects have an established diagnosis of asthma
- The definition of asthma. According to Chinese Guideline for the diagnosis and optimal management of asthma in children [Respiratory branch of pediatric society,Chinese Medical. Association. 2008, revised version], the subjects can be diagnosed when meeting the criteria. The diagnosis criteria is listed in the protocol.
- The severity of an acute exacerbation of asthma is defined as PEF of 50% to 75% predicted via a peak flow meter, with a clinical scoring index of ≥2. The clinical scoring index represents the sum of the score for each of four signs: respiratory rate (0=low to 3=high, dependent on age), wheezing (0=none to 3=severe), inspiration/expiration ratio (0=2:1 to 3=1:3), and accessory muscle (0=none to 3=marked use).
- Subjects can properly use a mini-wright peak flow meter, nebulizer and MDI with/without a spacer, and accurately complete a diary card with parental assistance, if required.
- Subjects’ parents/guardians are willing to give written informed consent. |
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E.4 | Principal exclusion criteria |
- Severe respiratory dysfunction.
- History of mechanical ventilation due to respiratory failure.
- Admission to hospital due to respiratory disease within the previous 2 weeks, including asthmatic exacerbations.
- Clinical or lab evidence of a serious, uncontrolled systemic disease or presence of any disease likely to interfere with the objectives of this study, such as pulmonary cystic fibrosis and bronchopulmonary dysplasia.
- Known or suspected hypersensitivity to glucocorticosteroids or β2 agonists.
- Clinical visual evidence of oral candidiasis at Visit1.
- Use of the medications below in Table 1 according to the following defined time intervals prior to presentation. The list is provided in the protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean morning PEF on diary card over the treament assessment period |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Mean evening PEF on diary card over the treatment assessment period
- Median Day-time and night-time symptom scores over the treatment assessment period
- Median number of use of rescue medications during and night over the treatment assessment period
-Clinic lung functions results performed in the clinic (FEV1 and FVC)
-Clinical scoring index
-Patient/ parent and investigator global evaluation |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |