| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Short-term lower leg growth rate in children with documented mild to moderate asthma. |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10003553 |
| E.1.2 | Term | Asthma |
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| 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 demonstrate non-inferiority of Qvar® 100 µg bd relative to a reference formulation, Beclazone® 200 µg bd, in terms of the short-term growth rate of the right lower leg, measured by knemometry, in children with documented mild to moderate asthma |
|
| E.2.2 | Secondary objectives of the trial |
To determine the lower leg growth rate during each of the two active treatments compared with lower leg growth rate during run in.
To assess the 24-h urine free cortisol/creatinine levels during the two active treatments.
To assess the 24-h urine free cortisol/creatinine levels during each of the two active treatments compared with run in levels.
To monitor the effect of the Qvar® formulation, 100 µg bd, and the reference formulation on the use of short-acting beta-agonist (SABA) rescue medication and lung function (PEF).
To examine the safety and tolerability profile of Qvar® 100 µg bd, as measured by the incidence and severity of spontaneously reported adverse events (AEs), including asthma exacerbations.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Male and female pre-pubertal patients aged 5 to 11 years (inclusive) with a documented history and confirmed diagnosis of asthma of greater than or equal to 3 months.
2. Normal growth development (height between 3- and 97-percentiles according to standard growth charts).
3. Current use of either short-acting beta-2-agonist (SABA) and/or low-dose (less than or equal to 200 µg bd) inhaled corticosteroid.
4. Ability to correctly use a peak flow meter.
5. Demonstrated satisfactory technique in the use of pMDIs and spacer.
6. Willingness and ability to accurately complete patient diary cards with the assistance of their parents/ guardian.
7. Capability of reading and understanding informed consent (assent for those under the legal contractual age of consent) and the patient information leaflet by parents/ guardian.
8. Written informed consent by both parents/ guardian with assent from each patient before any trial procedure is carried out.
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|
| E.4 | Principal exclusion criteria |
1. Patients who have entered puberty.
2. Current or prior, i.e. in the 4 weeks preceding Visit 1, use of high-dose (> 200 µg bd) inhaled corticosteroids (for routine control of their asthma).
3. Concomitant severe diseases (e.g. bacterial infection, mycoses) or diseases which the Investigator believes are contraindications for the use of bronchodilators or which may affect the study outcome measures, including malignancy.
4. Suffering from chronic underlying systemic or lung disease, i.e., cystic fibrosis.
5. In-patient hospitalisation for acute therapy of asthma in the 3 months preceding Visit 1.
6. Current or recent (within 3 months of Visit 1) systemic (oral, parenteral or depot) corticosteroid therapy or receipt of more than three short courses of systemic corticosteroid therapy in the preceding year.
7. Continuous use of long-acting beta-agonists (inhaled, oral or otherwise) for asthma symptoms.
8. Asthma exacerbations or respiratory tract infection requiring antibiotic treatment during the past 6 weeks.
9. Known or suspected hypersensitivity to any ICS or any one of the excipients of the pressurised metered dose inhalers (pMDIs).
10. Inability to perform lung functions tests (PEF).
11. Patients who are unlikely to be compliant, take their medication as directed, complete the lung testing procedures, or attend scheduled clinic visits.
12. Participation in an investigational drug trial during 30 days preceding Visit 1.
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary endpoint is lower leg growth velocity, as measured by knemometry after 2 weeks of treatment, and will be calculated for each patient and for each treatment period in mm/week.
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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 | No |
| 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 | Yes |
| E.6.13.1 | Other scope of the trial description |
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| 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 | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | Yes |
| 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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| 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
| |
| 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 | 7 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 7 |
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