Allergic patients to Dermatophagoides pteronyssinus, with rhinoconjunctivitis or mild or moderate asthma MedDRA version: 17.1 Level: PT Classification code 10057631 Term: House dust allergy System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Polymerized Dermatophagoides pteronyssinus
Product Code: Der p pol
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Polymerized Dermatophagoides
Sponsors
Diater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >=18 and = 3.5 KU/L (CAP) in the year previous to the study; Positive Prick test 4. Clinical symptoms of rhinitis or rhinoconjunctivitis or mildr moderate ashtma. 5. Patients able to fulfill the treatment. 6. Women must have negative results in pregancy test. Pregnancy test must be done 7 days before the start of the study. 7. Only patients that the investigator considers that are stable for their allergy for the last six months could be participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with concomitant inmune alterations. 2. Poli-sensitized allergic patients to relevant allergens or no-controlled allergens. 3. Patients that received inmunotherapy against Dermatophagoides pteronyssinus in the last 3 years. 4. Patients with serious or persistent asthma 5. Malign diseases 6. Patients with cardiovascular diseases that could get worse after adrenalin administration 7. Active tuberculosis 8. Serious atopic eczema 9. Patients under betablockers treatment 10. Patients who decide not further to colaborate in trial 11. Pregnant or breastfeeding women 12. Severe episodes needed of hospital care related to asthma, or systemic steroid administration in the three months previous to the start of the assay. 13. Patients simultaneously participating in another clinical trial 14. Any other pathology that interfiere with the inmune response. 15. Chronic abuse of alcohol or other substances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the maximum no reactive dose of Polymerized Dermatophagoides pteronyssinus, administered intradermally;Secondary Objective: - Safety assessment - Maximum erythema diameter - Immunological biomarkers in blood sample;Primary end point(s): - Maximum wheal diameter;Timepoint(s) of evaluation of this end point: At time 0 and 15 minutes after treatment administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety assessment: record and follow-up of Adverse Reaction - Maximun erythema diameter - Immunological bimarkers in blood samples: specific der p 1 and der p 2 IgE and IgG4;Timepoint(s) of evaluation of this end point: - Safety assessment: along the study - Maximun erythema diameter: 15 minutes after administration - Immunological bimarkers: before and after the treatment | — |
Countries
Spain
Contacts
Public ContactClinical Trial Departament
Diater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas, S.A.
Outcome results
None listed