E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cholinergic urticaria |
Urticaria colinérgica |
|
E.1.1.1 | Medical condition in easily understood language |
Cholinergic urticaria |
Urticaria colinérgica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
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 |
Our primary endpoint will be the negativization of the exercise challenge test: We will perform the exercise challenge test following the European Guidelines |
Nuestra variable principal será la negativización de la prueba de esfuerzo. Vamos a realizar la prueba de esfuerzo siguiendo las directrices europeas para la urticaria colinérgica |
|
E.2.2 | Secondary objectives of the trial |
- Quality of Life: QoL will be assessed through the Spanish validated version of Chronic Urticaria quality of life (CU-Q2oL)
- Patient?s card: Use of medication, VAS, daily symptoms, emergency visits, days off work.
- Treatment drops off in each sequence.
- Adverse events. |
- Calidad de vida: la calidad de vida se evaluará mediante la versión española validada del cuestionario de calidad de vida para Urticaria crónica (CU-Q2oL)
- Tarjeta del Paciente: Incluirá el uso de medicación, la Escala visual Analógica (VAS9, los síntomas diarios, número de visitas a urgencias, y los días de baja laboral.
- Abandono del tratamiento en cada uno de los brazos de tratamiento.
- Reacciones adversas |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult female and male patients (age 14 years or older).
- Diagnosis of cholinergic urticaria trough clinical history and positive exercise challenge test.
- Non-respondent to supra therapeutic doses of antihistamines (defined as two folds the maximal dose included in the drug labeling)
- Written informed consent. |
- Pacientes mujeres y hombres mayores de 14 años.
- Con diagnóstico de urticaria colinérgica a través de la historia clínica y prueba de provocación positiva.
- No respondan dosis supra terapéuticas de antihistamínicos (definido como 2 veces la dosis máxima incluida en la ficha técnica)
? Consentimiento informado por escrito. |
|
E.4 | Principal exclusion criteria |
- Pruritus related to dermatitis or other skin condition.
- Any systemic disease that hampers follow up or interpretation of data.
- Omalizumab treatment within the previous 12 months.
- Any contraindication included in the drug labeling.
- Any other conditions that do not allow the accomplishment of the clinical trial requisites, such as the abuse of drugs or alcohol. |
- Cualquier enfermedad sistémica que dificulta el seguimiento o la interpretación de los datos.
- Tratamiento con omalizumab en los 12 meses anteriores.
- Presencia de dermatitis u otras enfermedades dermatológicas o asociadas con prurito.
- Cualquiera de las contraindicaciones establecidas de la ficha técnica: hipersensibilidad al principio activo o alguno de los excipientes.
- Embarazo o lactancia.
- Cualquier otra causa que pueda impedir el correcto cumplimiento del ensayo, como alcoholismo, drogadicción, etc |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Primary and secondary endpoints/outcome measures
Our primary endpoint will be the negativization of the exercise challenge test
- We will perform the exercise challenge test following the European Guidelines[14] for cholinergic urticaria. According with such guidelines, all centers will follow the same center standardized protocol. The patient will exercise in treadmill or running to the point of sweating and following for 15 more minutes, wearing warm clothing in a warm room. The test will be considered positive if exercise challenge leads to the typical rash over 10 minutes. |
Demostrar la eficacia y la seguridad de Omalizumab en una nueva indicación, urticaria colinérgica.
Variable principal
- Nuestra variable principal será la negativización de la prueba de esfuerzo. Vamos a realizar la prueba de esfuerzo siguiendo las directrices europeas para la urticaria colinérgica [17]. Todos los centros seguirán el mismo protocolo estandarizado. De acuerdo con estas directrices, el paciente realizará ejercicio en un tapiz rodante o realizará una carrera libre durante 15 minutos tras comenzarla sudoración, llevando ropa de abrigo en una habitación caliente. La prueba se considera positiva si si el paciente experimenta la erupción cutánea característica durante los 10 minutos posteriores al ejercicio. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
To better assess the safety of the medication in the indication under study, the blind clinical trial comprising 4 months will be followed by an open label period of 8 months in which all patients will receive the active drug (pharmacovigilance period). |
Para evaluar mejor la seguridad del medicamento en la indicación en estudio, el ensayo clínico ciego comprende 4 meses seguido de un período abierto de 8 meses de duración en el que todos los pacientes recibirán el fármaco activo (período de farmacovigilancia). |
|
E.5.2 | Secondary end point(s) |
Secondary end point(s)
- Quality of Life:
- QoL will be evaluated through the Spanish validated version of Chronic Urticaria quality of life (CU-Q2oL)
- Patient?s card:
- Use of medication, VAS, daily symptoms, emergency visits, days off work.
- Treatment drops off in each sequence.
- Adverse events. |
Variables secundarias
- Calidad de vida: la calidad de vida se evaluará mediante la versión española validada del cuestionario de calidad de vida para Urticaria crónica (CU-Q2oL)
- Tarjeta del Paciente: Incluirá el uso de medicación, la Escala visual Analógica (VAS9, los síntomas diarios, número de visitas a urgencias, y los días de baja laboral.
- Abandono del tratamiento en cada uno de los brazos de tratamiento.
- Reacciones adversas |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
To better assess the safety of the medication in the indication under study, the blind clinical trial comprising 4 months will be followed by an open label period of 8 months in which all patients will receive the active drug (pharmacovigilance period). |
Para evaluar mejor la seguridad del medicamento en la indicación en estudio, el ensayo clínico ciego comprende 4 meses seguido de un período abierto de 8 meses de duración en el que todos los pacientes recibirán el fármaco activo (período de farmacovigilancia). |
|
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) | 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 | No |
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.8.5 | 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |