E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
The main objective of this study is to compare salmeterol/fluticasone propionate 50/100mcg bd with fluticasone propionate (FP) 200mcg bd on lung function in subjects that are not controlled when previously treated at medium daily doses of inhaled corticosteroids alone. |
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E.2.2 | Secondary objectives of the trial |
• To evaluate if total controlled asthma is achievable in children and to compare salmeterol/fluticasone propionate 50/100mcg bd with fluticasone propionate (FP) 200mcg bd on this endpoint after a 12-week treatment period (see Section 3.3 for the definition of ‘total control’). • To evaluate if well controlled asthma is achievable in children and to compare salmeterol/FP 50/100mcg bd with FP 200mcg bd on this endpoint after a 12-week treatment period (see Section 3.3 for the definition of ‘well control’). • To evaluate if asthma control as defined in adults is applicable in children, or if other endpoints, (i.e. asthma due to exercise or variability of PEF), have to be integrated in the definition of asthma control in children.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male or female children aged 4-11 years
2. A documented clinical history of asthma for a period of at least 6 months
3. A documented history (within 12 months of Visit 1) of airway reversibility of ≥ 15% based either on FEV1 or PEF measured pre and post inhalation of 200 mcg salbutamol. (If no documented history of reversibility exists, patients must demonstrate a ≥15% reversibility at Visit 1).
4. Receiving an inhaled corticosteroid at a medium dose (beclomethasone dipropionate HFA non fine particle = 400-500 mcg/day or beclomethasone HFA fine particle = 200mcg/day, or budesonide =400 mcg/day or fluticasone = 200-250 mcg/day) for at least 3 months prior to Visit 1 and at a stable dose for at least 4 weeks prior to Visit 1
5. Able to use the Mini-Wright peak flow meter and subject or parent/guardian had to be able to record the subject’s maximum PEF correctly
6. Able to perform FEV1 correctly
7. Subject’s guardian/parent able to complete an eDRC on behalf of the subject. The eDRC should be completed by the guardian/parent.
8. Able to use a DISKUS™ correctly
9. At least one parent(s)/guardian(s) has to give written informed consent to participate in the study
10. At the end of the run-in period (Visit 2), subjects must still meet the criteria for entry into the run-in period and also have not achieved the criteria for the ‘Well-controlled’ asthma during two or more of the 4 weeks prior to Visit 2
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E.4 | Principal exclusion criteria |
Exclusion criteria for entry into the run-in period: A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Female subjects who have reached menarche
- Received any investigational study medication in the 4 weeks prior to Visit 1
- Experienced a respiratory tract infection in the 4 weeks prior to Visit 1
- Experienced an acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalisation within 12 weeks of Visit 1
- Any use of oral/parenteral or depot corticosteroid within 12 weeks of Visit 1
- Any use of long-acting inhaled beta2-agonists or oral beta2-agonists within 4 weeks of Visit 1
- Any use of leukotriene antagonists or theophyllines within 4 weeks of Visit 1
- Any known clinical or laboratory evidence of a serious uncontrolled disease (including serious psychological disorders) which is, in the opinion of the Investigator, likely to interfere with the study
- Subjects with a known or suspected hypersensitivity to inhaled corticosteroids, beta2-agonists, or any components of the formulations (e.g. lactose)
- A relative of any of the site staff, including the investigator or study co-coordinator
- Has previously been entered into this study
Exclusion criteria for entry into the treatment period: Subjects will be excluded from participating in the treatment period of the study if the following occurred during the run-in period:
- Pre-bronchodilator FEV1 <60% (assuming that measurement was correctly performed)
- Any change in asthma medication (excluding use of prophylactic study specific salbutamol for prevention of asthma symptoms due to exercise)
- Respiratory tract infection or asthma exacerbation
- Use of oral, parenteral or depot corticosteroids
- Emergency visit due to asthma
- Non-compliance with the completion of the eDRC (i.e. during the 4 week period between visits, non compliance is defined as less than 5 days of completed data within any one week for four weeks – subjects must complete at least 5 days a week for the entire run-in period).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the mean morning PEF over 12 weeks recorded in the electronic Diary Record Card (eDRC). |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Information not present in EudraCT |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |