E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
One hundred and sixty children with allergic or non-allergic asthma, deficit, insufficiency or normal levels of Vitamin D. |
Ciento sesenta niños con asma alérgico o no alérgico, con déficit, insuficiencia o con niveles normales de Vitamina D. |
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E.1.1.1 | Medical condition in easily understood language |
One hundred and sixty children with allergic or non-allergic asthma, deficit, insufficiency or normal levels of Vitamin D. |
Ciento sesenta niños con asma alérgico o no alérgico, con déficit, insuficiencia o con niveles normales de Vitamina D. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
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 |
1. To know if there is any significant association between asthma and vitamin D deficiency. |
1. Conocer si hay asociación significativa entre el asma y el déficit de vitamina D. |
|
E.2.2 | Secondary objectives of the trial |
2. To know if the treatment of vitamin D deficit, decrease the number of exacerbations of asthma, daytime cough, nocturnal cough, dyspnea on exertion, allergic rinconjuntivitis, the need for basic treatment, the number of visits to an emergency department for asthma, the number of hospital admissions for asthma and markers of airway inflammation (exhaled nitric oxide). 3. To know if there is any difference in response to treatment with vitamin D according to the etiological origin (allergic or non allergic). |
2. Conocer si el tratamiento del déficit de vitamina D disminuye el número de exacerbaciones asmáticas, la tos diurna, la tos nocturna, la disnea de esfuerzo, la rinconjuntivitis alérgica, la necesidad de tratamiento de base, el número de visitas a un servicio de Urgencias por asma, el número de ingresos hospitalarios por asma y los marcadores de inflamación bronquial (óxido nítrico exhalado). 3. Conocer si hay diferencia en la respuesta al tratamiento con vitamina D según el asma sea de etiología alérgica o no. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Children between 6 and 18 years, with allergic asthma or non allergic asthma, with frequent or moderate episodics with good clinical control and respiratory function, with or without deficit of vitamin D. 2. Acceptance by the parents, with the sign in the informed consent. 3. In some subgroups, the patients should comply with the criteria established.(deficit or insufficiency of Vitamin D). |
1. Niños de 6-18 años que cumplan los criterios de asma alérgico/no alérgico episódica frecuente o persistente moderada con buen control clínico y funcional respiratorio, con/sin déficit de vitamina D. 2. Aceptación por partes de los padres de participar en el estudio, con firma del consentimiento informado. 3. Los niños de los grupos caso deben cumplir los crierios establecidos para cada subgrupo. |
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E.4 | Principal exclusion criteria |
Not acceptance by the parents |
Negativa de los padres a aceptar su participación en el estudio |
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E.5 End points |
E.5.1 | Primary end point(s) |
CAN questionary - Asthma control Asthma classification according to the GEMA 2009 classification Exhaled nitric oxide Sun exposure Type of alimentation Leveles of vitamin D Spirometry test Prick test Análisis de sangre |
Cuestionario CAN. Clasificación del asma según clasificación GEMA 2009 Óxido Nítrico exhalado Exposición solar Tipo de alimentación Niveles de vitamina D Espirometría Prick test Análisis de sangre |
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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 | No |
E.8.1.1 | Randomised | No |
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 | 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 | 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 | 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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The end of the trial is the last visit of the last subject |
El final del estudio es la última visita del último sujeto |
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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 | 8 |
E.8.9.1 | In the Member State concerned days | |