Allergic rhinoconjunctivitis with or without associated mild or moderate asthma. MedDRA version: 14.0 Level: HLGT Classification code 10021505 Term: Immunology and allergy investigations System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: Alt a 1
Product Code: Alt a 1
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: Alérgeno mayor Alt a 1 del hongo de la especie Alternaria alternata
Concentrat
Sponsors
DIATER Laboratorio de Diagnostico y Aplicaciones Terapéuticas S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pacientes con edades comprendidas entre los 12 y 55 años. 2. Paciente que haya otorgado su consentimiento informado para participar en el estudio así como los tutores o representantes legales, si es menor de edad. 3. Demostración de sensibilidad a la fuente alergénica: -Presencia de IgE específica a Alt a 1 0.7 KU/L (CAP) y -Pruebas cutáneas alérgeno-específicas positivas (Alternaria alternata y a Alt a 1), al menos con una pápula de 3 mm con respecto al control negativo. 4. Demostración clínica de patología concordante con cuadros de rinitis o rinoconjuntivitis con o sin asma leve o moderada asociada. 5. Paciente capaz de cumplir con el tratamiento y de completar una tarjeta diario del paciente durante el desarrollo del estudio, para la autoevaluación de la puntuación de síntomas y registro de medicación sintomática. 6. Las mujeres en edad fértil deben presentar una prueba de embarazo en orina con resultado negativo en los 7 días previos a la inclusión en el ensayo. Además, las mujeres en edad fértil, deben comprometerse a utilizar un método anticonceptivo adecuado durante el estudio si son sexualmente activas. 7. Pacientes que responda a los criterios anteriores y que considere el investigador que se ha mantenido estable en un periodo de 6 meses previos a la entrada en el estudio. Are the trial subjects under 18? yes Number of subjects for this age range: 132 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 132 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Coexisting autoimmune diseases 2. In polysensitized that are relevant allergen and uncontrolled. 3. Having received immunotherapy with Alternaria in the 3 years prior to the commencement of the trial. 4. Patients with severe asthma. 5. Malignancies. 6. Cardiovascular disorders, which may be aggravated by the use of adrenaline. 7. Active tuberculosis. 8. Patients treated with beta blockers. 9. Impossibility of proper enforcement of immunotherapy program. 10. Pregnant or nursing mothers or women of childbearing age who do not commit to use adequate contraception if sexually active and have not proven to have been surgically sterilized or who have some form of inability to play. 11. Simultaneous participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): A combined index of frequency, severity of symptoms and symptomatic medication use;Main Objective: To evaluate the efficacy of specific immunotherapy with purified major allergen Alt a 1 of the fungus Alternaria alternata administered subcutaneously;Secondary Objective: To evaluate the safety of specific immunotherapy with purified major allergen Alt a 1 of the fungus Alternaria alternata administered subcutaneously;Timepoint(s) of evaluation of this end point: throughout all the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Frequency and severity of symptoms as a whole or separately. -Consumption of symptomatic medication. -Assessment of clinical and immunological markers (inflammatory biomarkers: Ee Ig, IgG Ge, IGI G4e) -Safety Assessment. -Quality of Life Questionnaire rhinitis (15 items).;Timepoint(s) of evaluation of this end point: throughout all the study | — |
Countries
Spain
Contacts
Public ContactJulian Campos Fernandez
DIATER Laboratorio de Diagnostico y Aplicaciones Terapéuticas S.A.
Outcome results
None listed