Apr. El asma bronquial es una enfermedad inflamatoria crónica de las vías respiratorias ( ) Según investigaciones realizadas en occidente, el asma está presente en el . los reportes de la Global Initiative for Asthma (GINA)(1,2) postulan la calidad de la. IgE-mediated allergic bronchial asthma treated according GINA step Asma bronquial alérgico mediado por IgE según criterios GINA The update of the Global Strategy for Asthma Management and Prevention incorporates new scientific information about asthma based on a review of.

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Clinical trials The European Union Clinical Trials Register allows you to search for protocol and results information on: Cancer AND drug name. Pneumonia AND sponsor name.

How to search [pdf]. 210 these items you should use the filters and not add them to your search terms in the text field. Trials with results Trials without results Clear advanced search filters. Review by the Competent Authority or Ethics Committee in the country concerned.

EU Clinical Trials Register.

Both Female Only Male Only. IMP with orphan designation in the indication. Trials with results Trials without results. Clear advanced search filters. Date on which this record was first entered in the EudraCT database:.

A multicenter randomized double-blind adaptive placebo-controlled clinical trial for evaluation of efficacy and safety of specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of house dust mite Dermatophagoides pteronyssinus in patients with allergic bronchial asthma and with allergic rhinitis or rhinoconjunctivitis.

Title of the trial for lay people, in easily understood, i. Phase III trial of specific immunotherapy with allergoid preparation of house dust mite in patients with allergic bronchial asthma and with allergic rhinitis or rhinoconjunctivitis. The IMP has been designated in this indication as an orphan drug in the Community.

Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy. The aim of this clinical trial is to demonstrate efficacy and to evaluate safety of AIT with an aluminium hydroxide adsorbed allergoid preparation of bdonquial allergens of D p in patients with allergic bronchial asthma acc.


Written informed consent and assent according to local requirements before any trial-related activities started a trial-related activity is any procedure that would not have been performed during the routine management of the patient. Male or female outpatient between 12 and 65 years both inclusive 3. Unable to understand and comply with the requirements of the trial, as judged by the investigator 2.

Currently participating in any other trial or in participating in any other trial within 30 days before inclusion in this trial 3. Low compliance, persistent incorrect inhaler technique as assessed by the investigator or inability to understand instructions or trial documents 4. Involved in the planning sefun conduct of the trial 5. KG or of one of the trial sites 6.


Any relationship of dependence with the sponsor or with the investigator 7. Previously enrolled or randomized to treatment in the present trial 8. Institutionalized due to an official or judicial order For females with childbearing potential i. Positive pregnancy test Pregnant, breast feeding or wishes to breast feed Seeking to become pregnant during the course of the trial Immunotherapy criteria: Any AIT with house dust mites Current treatment with any kind of immunotherapy Any AIT with unknown allergen Clinically relevant symptoms to other regional specific allergens which interfere with the assessment period of October to January.

Exceptions are symptoms to allergens of cat and dog, if the patient has no direct contact to these animals. Exceptions are sensitizations to storage mites if the sensitization assessed by immunoassay is lower than the sensitization to at least one of the house dust mites D p or D f.

Exceptions are sensitizations assessed by immunoassay to cat and dog, if the patient has no direct contact to these animals. Diseases and health status: Clinically relevant rhinitis or respiratory symptoms related to other reasons e. Asthma or rhinitis symptoms for 20 years or longer And the usual exclusion criteria for immunotherapy regarding health status and medical requirement.


Incapacidad de entender y cumplir con los requerimientos del ensayo, a juicio del investigador 2.

KG o de cualquiera de los centros participantes en el ensayo 6. Previamente incluido o aleatorizado a tratamiento en el ensayo actual 8.

Personas con discapacidad mental 9. Test de embarazo positivo Embarazadas, en period de lactancia o awma deseos de lactancia Tratamiento actual con cualquier tipo de inmunoterapia Excepto sensibilizaciones evaluadas por inmunoensayo segn gato y perro, si el paciente no tiene contacto directo con estos animales Enfermedades y estado de salud: VIH, pacientes post- trasplantados, lupus eritematoso, enfermedad de Grave En tratamiento o que hayan completado tratamiento con anticuerpos anti-IgE En tratamiento a largo plazo o que hayan completado tratamiento con tranquilizantes u otras drogas psicoactivas This is a confirmatory phase III pivotal study.

Clinical trials

The ICS dose will be determined by means of diary entries as described in Section 5. Este es un estudio pivotal de fase III confirmatorio. The following secondary endpoints will be assessed: The trial involves single site in the Member State concerned.

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial. The end of the trial is defined as the date of last database lock in order to permit data cleaning after the last patient visit. Plans for treatment or care after the subject has ended the participation in the trial if it is brobquial from the expected normal treatment of that condition.