E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bronchiolitis |
Bronquiolitis |
|
E.1.1.1 | Medical condition in easily understood language |
Bronchiolitis |
Bronquiolitis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 | 10000688 |
E.1.2 | Term | Acute bronchitis and bronchiolitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 |
determination the efficacy (measured in reduced time until clinical normalization) of hypertonic saline 3% (SSH) compared nebulized saline (SSF) in the treatment of bronchiolitis in hospitalized patients between 7 days and 6 months age. |
Determinar la eficacia (medida en reducción del tiempo necesario hasta la normalización clínica) del Suero Salino Hipertónico al 3% (SSH) nebulizado comparado con el Suero Salino Fisiológico (SSF) en el tratamiento de la bronquiolitis en los pacientes hospitalizados con edades comprendidas entre los 7 dias y los 6 meses de edad. |
|
E.2.2 | Secondary objectives of the trial |
Compare the length of hospital stay of patients treated with nebulized SSH versus SSF nebulized.
Compare the length of hospital stay, time to clinical normalization
Check the safety of nebulized SSH in this population.
Compare between both groups the rate of need for rescue treatment, need for respiratory support and relapse rate. |
Comparar la duración de la estancia hospitalaria de los pacientes tratados con SSH nebulizado versus SSF nebulizado.
Comparar la duración de la estancia hospitalaria con el tiempo necesario para normalización clínica.
Comprobar la seguridad del SSH nebulizado en esta población.
Comparar entre ambos grupos la tasa de necesidad de tratamiento de rescate, de necesidad de asistencia respiratoria y la tasa de recaídas. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age between 7 days and 6 months.
Diagnosis of moderate-serious bronchiolitis (first episode of wheezing lower respiratory difficulty in the context of the upper airways viral infection ) which require hospital admission in participating sites(Score Wood-Downes modified between 4-7).
Informed consent from Parents or guardians according to the current legislation on clinical research (Declaration of Helsinki, Law 14/2007 of 3 July biomedical research) |
Edad comprendida entre los 7 dias y los 6 meses.
Diagnóstico de bronquiolitis (primer episodio de dificultad respiratoria baja con sibilancias en el contexto de una infección viral de vías aéreas superiores) moderada-grave que precise ingreso hospitalario en los centros participantes (Score de Wood-Downes modificado entre 4 y 7).
Consentimiento informado de los padres o tutores siguiendo la normativa vigente en materia de investigación clínica (Declaración de Helsinki, Ley 14/2007 de 3 de julio de investigación biomédica) (ver Anexo 4) |
|
E.4 | Principal exclusion criteria |
Severe bronchiolitis requiring ventilation or admission to ICU when the patient has an oxygen saturation <94 with oxygen supply> 2l/min, a Score ≥ 8 and / or PaCO2 ≥ 65 mmHg, assessing the indication for assisted ventilation (high-flow systems, C-PAP, ventilation invasive mechanical) and / or transfer to the Pediatric Intensive Care Unit with the practice of each hospital.
Cardiac or pulmonary disease base.
Previous diagnosis of asthma.
Use of bronchodilators.
Need for cardiopulmonary resuscitation.
Inability to use nebulizer.
Concomitant use of antibiotics.
Use of corticosteroids.
No informed consent.
Prescribed treatment with nebulized epinephrine |
Bronquiolitis grave que requiera asistencia respiratoria o ingreso en CIP(cuando el paciente presente una saturación de oxígeno < 94 con aportes de oxígeno > 2l/min, un Score ≥ 8 y/o PaCO2 ≥ 65 mmHg, se valorará la indicación de asistencia respiratoria (sistemas de alto flujo, C-PAP, ventilación mecánica invasiva) y/o traslado a la Unidad de Cuidados Intensivos Pediátricos según la práctica habitual de cada hospital)..
Enfermedad pulmonar o cardiaca de base.
Diagnóstico previo de asma.
Uso de broncodilatadores.
Necesidad de reanimación cardiopulmonar.
Incapacidad para usar nebulizador.
Uso concomitante de antibióticos.
Uso de corticoides.
No consentimiento informado.
Tratamiento pautado con adrenalina nebulizada. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
determination the efficacy (measured in reduced time until clinical normalization) of hypertonic saline 3% (SSH) compared nebulized saline (SSF) in the treatment of bronchiolitis in hospitalized patients between 7 days and 6 months age. |
Determinar la eficacia (medida en reducción del tiempo necesario hasta la normalización clínica) del Suero Salino Hipertónico al 3% (SSH) nebulizado comparado con el Suero Salino Fisiológico (SSF) en el tratamiento de la bronquiolitis en los pacientes hospitalizados con edades comprendidas entre los 7 dias y los 6 meses de edad. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Compare the length of hospital stay of patients treated with nebulized SSH versus SSF nebulized.
Compare the length of hospital stay, time to clinical normalization
Check the safety of nebulized SSH in this population.
Compare between both groups the rate of need for rescue treatment, need for respiratory support and relapse rate. |
Comparar la duración de la estancia hospitalaria de los pacientes tratados con SSH nebulizado versus SSF nebulizado.
Comparar la duración de la estancia hospitalaria con el tiempo necesario para normalización clínica.
Comprobar la seguridad del SSH nebulizado en esta población.
Comparar entre ambos grupos la tasa de necesidad de tratamiento de rescate, de necesidad de asistencia respiratoria y la tasa de recaídas. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 months
6 month
12 months
6 months |
6 meses
6meses
12 meses
6 meses |
|
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
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
|
End of the trial will be last randomised patient last visit |
Ultima visita del último paciente incluido |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |