| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Pediatric patients aged 2 months to 12 years presenting secretory otitis |
| Pacientes pediatrícos de entre 2 meses a 12 años que presenten otitis secretora. |
|
| E.1.1.1 | Medical condition in easily understood language |
| Secretory Otitis |
| Otitis Secretora |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10033072 |
| E.1.2 | Term | Otitis externa |
| 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 |
| Evaluate the effectiveness of homeopathy coadyuvancia of aerosol treatment (mucolytics, corticosteroids), secretory otitis in pediatric patients 2 months to 12 years, making an intervention group who receive homeopathy and the control group will receive placebo. It will compare the effectiveness measured by pneumatic otoscopy |
| Evaluar la efectividad de la coadyuvancia de la homeopatía al tratamiento con aerosoles (mucolíticos-corticoides) , en las otitis secretoras de pacientes pediátricos de 2 meses a 12 años, realizándose un grupo de intervención, que recibirá homeopatía y otro grupo control que recibirá placebo. Se comparará la efectividad medida por medio de la otoscopia neumática |
|
| E.2.2 | Secondary objectives of the trial |
Coadyuvancia assess whether homeopathy could:
? reduce the number of surgeries (ear tubes (DTT) + / - adenoidectomy) and costs associated therewith
? reduce intercurrent acute otitis media (AOM), tympanic perforations or complicated acute otitis media during the course of the study.
? reduce truancy or parental occupation in relation to intercurrent AOM
? assess the safety of both treatments |
Valorar si la coadyuvancia con homeopatía podría:
? disminuir el número de intervenciones quirúrgicas ( drenajes transtimpánicos (DTT) +/- adenoidectomía) y los costes asociados a los mismos
? disminuir la intercurrencia de otitis medias agudas (OMA), perforaciones timpánicas u Otitis medias agudas complicadas durante el transcurso del estudio.
? disminuir del absentismo escolar, o laboral de los padres en relación con la intercurrencia de una OMA
? valorar la seguridad de ambos tratamientos |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- Age: 2 months - 12 years
- Informed consent from parents / guardians
- OS unilateral or bilateral consultations ENT diagnosed with pneumatic otoscopy as the presence or absence of tympanic mobility. Each ear will count as one unit primary endpoint.
- Not following any standard treatment, namely mainly steroids, antihistamines and mucolytics. |
- Edad: 2 meses ? 12 años
- Consentimiento informado por parte de padres y/o tutores
- OS uni o bilateral diagnosticada en consultas ORL con otoscopia neumática, según la presencia o ausencia de movilidad timpánica. Cada oído contará como una unidad de variable principal.
- No estar siguiendo ningún tratamiento habitual, concretamente especialmente corticoides, antihistamínicos y mucolíticos. |
|
| E.4 | Principal exclusion criteria |
- AOM or complicated at the time of baseline
- Not have passed the newborn hearing screenig (OAE)
- Concomitant diseases,
- Sensorineural hearing loss permanent
- Autism
- Down Syndrome or other craniofacial malformations,
- Malformations of the outer or middle ear
- Acute Mastoiditis and Cholesteatoma
- Vaccination recent (less than 30 days)
- Cilial motility disorders (Kartagener syndrome)
- Language Alterations or prelingual speech
- OSA
- Prior Adenoidectomy
- Persistence of DTT or perforated eardrum
- Lactose intolerance or diabetes (incompatible with placebo and homeopathy) |
- OMA o complicada en el momento de inicio del estudio
- No haber pasado el screenig auditivo neonatal (otoemisiones)
- Enfermedades concomitantes,
- Hipoacusia neurosensorial permanente,
- Autismo,
- Sind. Down u otras malformaciones craneofaciales,
- Malformaciones del oído externo o medio
- Colesteatoma o Mastoiditis aguda
- Vacunación reciente ( menos de 30 días)
- Trastornos de la motilidad cilial (Síndrome de Kartagener)
- Alteraciones del lenguaje o habla prelocutiva,
- SAOS,
- Adenoidectomía previa
- Persistencia de DTT o perforación timpánica
- Intolerancia a la lactosa o diabetes (incompatible con el placebo y la homeopatía) |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Bilateral pneumatic otoscopy (BPO): improvement or resolution of secretory otitis, tympanic mobility based on using the pneumatic otoscope (Halogen HPX insufflation with No. 25021 Welch Allyn). The test we consider our main result, to be negative when there is no tympanic mobility (secretory otitis presence) and positive when tympanic mobility (no secretory otitis).
Taking into account the mobility tympanic narrowly, leaving aside other (color, appearance of the eardrum) increases the sensitivity and specificity to 95%, 85%, respectively. (6).
Each ear was assessed separately, the main variable in the case of subjects with bilateral OS |
Otoscopia neumática bilateral (OPN): mejora o resolución de la otitis secretora, basándonos en la movilidad timpánica por medio del otoscopio neumático (Halogen HPX with insufflation nº 25021 de Welch Allyn). La consideraremos nuestra prueba de resultado fundamental, siendo negativa cuando no haya movilidad timpánica (presencia de otitis secretora) y positiva cuando haya movilidad timpánica (ausencia de otitis secretora).
Si se tiene en cuenta de manera restrictiva la movilidad timpánica, dejando de lado otras (color , apariencia del tímpano) se incrementa la sensibilidad y la especificidad hasta un 95%, 85% respectivamente. (6).
Se evaluará cada oído por separado, como variable principal en el caso de sujetos con OS bilateral |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
? bilateral Impedance: Jerger classification. This classification is based on the study of tympanic impedance curve (Model GSI-Auto-Tymp Version 2). Are three subtypes of curve A, B and C. Only Type B, plane curve, is considered suggestive of occupation of the middle ear by fluid (otitis secretory) (6). Each ear was assessed separately, the main variable in the case of subjects with bilateral OS.
? bilateral optical microscope: in order to visualize features of the tympanic membrane and middle ear characteristics such as amber, delustrado, bulging, or retraction fluid level shall be considered suggestive of secretory otitis. Each ear was assessed separately, the main variable in the case of subjects with bilateral OS. Each ear was assessed separately, the main variable in the case of subjects with bilateral OS.
? Acute otitis media: occupation of the middle ear for signs of mucus associated with inflammation of the tympanic membrane. We will assess the number of acute otitis media or bilateral breakthrough, defined as ear pain and / or otorrhea, or has been diagnosed by a pediatrician, otolaryngologist or primary care physician throughout the study period, without being denied treatment at any time for currently used in our hospital. Each ear was assessed separately, the main variable in the case of subjects with bilateral OS.
? Acute Mastoiditis: mastoid osteitis with risk of spread to adjacent structures secondary to acute otitis media, which has been diagnosed by a pediatrician, otolaryngologist or primary care physician throughout the study period, without being denied treatment at any time for currently used in our hospital. Each ear was assessed separately, the main variable in the case of subjects with bilateral OS.
? tympanic perforation: disruption of the continuity of the tympanic membrane, which have been diagnosed by a pediatrician, otolaryngologist or primary care physician throughout the study period, without being denied appropriate treatment currently in use in our hospital. Each ear was assessed separately, the main variable in the case of subjects with bilateral OS.
? Truancy: ie, number of days the patient has had to miss school or daycare, because of ear infection process.
? Make at least 1 dose of treatment research: to be determined by verbal questionnaire to the legal representatives of the subject, and by checking the tube homeopathy, the patient has made at least 1 dose of treatment research in order to perform and safety analysis within a population group (see Annex XII. d.).
? Compliance with treatment: through the legal representative bring empty tubes corresponding homeopathic.
? Changes in the dose: it will record the new dose determined by the investigator and the justification for that change.
? Absenteeism, defined as number of days he / carers have had to be away from his job as a caregiver, because of ear infection process.
? Adverse drug reactions, in relation to both treatment groups throughout the study period. Study of safety and drug tolerance. Understood as mild, moderate or severe medically. It also follows a protocol to notify them (see Annex X).
? Cause of early termination of the treatment of EC: why it was decided to discontinuation of treatment, whether by family members or legal guardians of the patient, the investigator or the study sponsor. Such cause shall be recorded in the CRD. |
?Impedanciometría bilateral: clasificación de Jerger. Esta clasificación se basa en el estudio de la curva de impedanciometría timpánica (Modelo GSI-Auto-Tymp Versión 2). Se incluyen tres subtipos de curva A, B y C. Sólo la curva tipo B, curva plana, se considerará sugestiva de ocupación del oído medio por líquido (otitis secretora) (6). Se evaluará cada oído por separado, como variable principal en el caso de sujetos con OS bilateral.
?Microscopio óptico bilateral: con el fin de visualizar características de la membrana timpánica y del oído medio Características como : ambarino, delustrado, abombado, nivel hidroaéreo o retracción, se considerarán sugestivas de otitis secretora. Se evaluará cada oído por separado, como variable principal en el caso de sujetos con OS bilateral. Se evaluará cada oído por separado, como variable principal en el caso de sujetos con OS bilateral.
?Otitis media aguda: ocupación del oído medio por moco asociado a signos de inflamación de la membrana timpánica. Valoraremos el número de otitis media aguda uni o bilaterales intercurrentes, entendida como otalgia y/u otorrea, o que hayan sido diagnosticadas por pediatra, otorrinolaringólogo o médico de atención primaria, durante todo el periodo de estudio, sin serle negado en ningún momento el tratamiento correspondiente actualmente en uso en nuestro ámbito hospitalario. Se evaluará cada oído por separado, como variable principal en el caso de sujetos con OS bilateral.
?Mastoiditis aguda: osteítis mastoidea con riesgo de difusión a estructuras adyacentes, secundaria a una otitis media aguda, que haya sido diagnosticadas por pediatra, otorrinolaringólogo o médico de atención primaria, durante todo el periodo de estudio, sin serle negado en ningún momento el tratamiento correspondiente actualmente en uso en nuestro ámbito hospitalario. Se evaluará cada oído por separado, como variable principal en el caso de sujetos con OS bilateral.
?Perforación timpánica: disrupción de la continuidad de la membrana timpánica, que hayan sido diagnosticadas por pediatra, otorrinolaringólogo o médico de atención primaria durante todo el periodo de estudio, sin serle negado el tratamiento correspondiente actualmente en uso en nuestro ámbito hospitalario. Se evaluará cada oído por separado, como variable principal en el caso de sujetos con OS bilateral.
?Absentismo escolar: entendida como número de días que el paciente ha tenido que faltar a la escuela o guardería, por causa de proceso infeccioso auditivo.
?Realización de al menos 1 dosis del tratamiento de investigación: se determinará mediante cuestionario verbal a los representantes legales del sujeto, y mediante la comprobación del tubo de homeopatía, que el paciente ha realizado al menos 1 dosis del tratamiento de investigación, para poder realizar así análisis de seguridad dentro de un grupo poblacional ( ver anexo XII. d.).
?Cumplimiento del tratamiento: por medio de que el representante legal traiga los tubos homeopáticos vacíos correspondientes.
?Modificaciones de las dosis: se registrará la nueva posología decidida por el investigador y la justificación de dicha modificación.
?Absentismo laboral; entendida como número de días que el/los cuidadores hayan tenido que ausentare de su puesto laboral el cuidador, por causa de proceso infeccioso auditivo.
?Reacciones adversas medicamentosas; en relación con ambos grupos de tratamiento, durante todo el periodo de estudio. Estudio de seguridad y tolerancia a los medicamentos. Entendidas como leves, moderadas o severas según criterio médico. Asimismo se seguirá un protocolo de notificación de las mismas (ver anexo X).
? Causa de interrupción anticipada del tratamiento del EC: motivo por el cual se decide la interrupción del tratamiento, ya sea por decisión de los familiares o tutores legales del paciente, por el investigador responsable o por el promotor del estudio. Se registrará dicha causa en el CRD. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| 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) | 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
| 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
|
| Only complete the examination prior to the last patient last visit for security reasons to sponsor criteria |
| Solo se finalizará el estudio antes de realizar la ultima visita del ultimo paciente por motivos de seguridad a criterios del promotor. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 3 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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