E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
paediatric patients suffering from effort asthma |
pazienti pediatrici con asma da sforzo |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003558 |
E.1.2 | Term | Asthma extrinsic |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 objective of the study is evaluates the vitamin D administration’s effect on respiratory function in paediatric patients with a symptomatology consistent with effort asthma and a ΔFEV1≥ 20% to effeort test |
Lo studio si prefigge di studiare l’effetto della somministrazione di Vitamina D sulla funzionalita' respiratoria di pazienti pediatrici che mostrino una sintomatologia compatibile con un quadro d’asma da sforzo e un ΔFEV1≥ 20% al test da sforzo |
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E.2.2 | Secondary objectives of the trial |
To dose cells producing IL-10 and IL-17 and pulmonary levels, estimated on sputum, and on the serum surfactant protein D |
Dosare le cellule in grado di produrre IL-10 e IL-17 e i livelli polmonari, misurati sullo sputo, e sierici di proteina surfattante D. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Paediatric patients (male and female) with: - age between 6 and 14 years - symptomatology consistent with effort asthma - decrease of FEV1≥ 20% to effort asthma - short term β2 agonist therapy, not intake during 12 hours before the test - perpetual allergenes sensitivity |
Pazienti pediatrici (maschi e femmine) che presentino: • eta' compresa fra i 6-14 anni • sintomatologia compatibile con quadro d’asma da sforzo • caduta del FEV1≥ 20% al test da sforzo • terapia con β2 agonisti a breve durata, non assunti nelle 12 ore precedenti il test • sensibilita' ad allergeni perenni |
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E.4 | Principal exclusion criteria |
- children treated with long term β2 agonist therapy in the last 3 months - antileucotrienic drugs intake in the last month - systemic and inhaled corticosteroid therapy in the last 3 months - VitD supplements in the last year - intake of short term β2 agonist therapy during 12 hours before the test - seasonal allergenes sensitivity during the season of highest allergene concentration and chronic inflammatory disease |
• bambini in terapia con β2 agonisti a lunga durata negli ultimi 3 mesi • in terapia con farmaci antileucotrienici nell'ultimo mese • in terapia con corticosteroidi sia per via inalatoria che sistemici negli ultimi 3 mesi • che abbiano fatto uso di integratori per VitD nell'ultimo anno •che abbiano fatto uso di β2 agonisti a breve durata nelle 12 ore precedenti il test • sensibili ad allergeni stagionali durante la stagione di massima concentrazione dell'allergene affetti da patologie infiammatorie croniche |
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement in effort test with an increase of 10% at least in treated patients |
Miglioramento al test da sforzo con un miglioramento atteso almeno del 10% nei pazienti trattati |
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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) |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |