E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild asthma in children (males and females) 6-14 years |
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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 | 10049585 |
E.1.2 | Term | Infantile 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 |
The primary objective of the study is to compare lower leg growth rate (LLGR), measured by knemometry, over a 2-week treatment period with BDP HFA pMDI 200 µg b.i.d. using AeroChamber Plus™ spacing device versus BDP HFA pMDI 200 µg b.i.d. using Volumatic™ spacing device. The study is aiming at showing non-inferiority of BDP HFA 200 µg administered via AeroChamber Plus™ spacer vs. the same treatment administered via Volumatic™ spacer.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives will be to evaluate the effects of the BDP HFA pMDI 100 µg b.i.d. versus 200 µg b.i.d., both administered via AeroChamber Plus™ spacers on the lower leg growth rate, the lower leg growth rate in each of the three active treatments versus lower leg growth rate in the single-blind placebo run-in period, the lung function measured by PEF, and the 24-hour urinary free cortisol. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Prepuberal male and female outpatients, ≥ 6 and ≤ 14 years old in Tanner stadium I. 2. Written informed consent by parents/legal representatives. 3. Subject’s written informed consent (when appropriate). 4. Clinical diagnosis of mild asthma during at least two months prior to screening visit. 5. Peak Expiratory Flow (PEF) and Forced Expiratory Volume during the first second (FEV1) > 80% of predicted normal values at screening visit. 6. Treated with inhaled beta 2-agonists as required and/or inhaled dry powder Budesonide (Spirocort®) up to 400 µg daily or equivalent treatments. 7. Compliant to study procedures and able to visit the centre for controls as reported into the protocol. 8. A cooperative attitude and ability to be trained in the proper use of a pMDI and spacers.
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E.4 | Principal exclusion criteria |
1. Girls and boys in Tanner stadium II-V. 2. Endocrinological diseases including growth impairment or other chronic diseases. 3. Known sensitivity to the components of study medication. 4. Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids. 5. Allergy to one component of medications used. 6. Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids. 7. Having received an investigational drug within 2 months before the current study. 8. Patient’s participation in another clinical trial in parallel with the present study. 9. Inability to perform outcome measurements optimally and to complete diary cards.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the lower leg growth rate, measured by knemometry, over a 2-week treatment period with BDP HFA pMDI 200 µg bid using Volumatic Spacer versus BDP HFA pMDI 200 µg bid using AeroChamber Plus spacer. |
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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 |
The study is aiming at showing non-inferiority of BDP HFA 200 µg administered via AeroChamber Plus™ |
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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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
BDP HFA 200 µg adm with reference spacer Volumatic or AeroChamber Plus |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
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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 | 5 |
E.8.9.1 | In the Member State concerned days | |