Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: subcutaneous immunotherapy with DPT extract; Subcutaneous depot placebo
Intervention description: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units); Increasing doses of subcutaneous depot placebo in three different scales
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Allergy; Immunotherapy; Allergic Rhinoconjunctivitis; D. pteronyssinus; house dust allergy

Summary:

      Based on EMA (European Medicines Agency) new guidelines on the clinical development of
      products for immunotherapy for the treatment of allergic diseases the aim of this study was
      to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations
      in patients allergic to Dermatophagoides pteronyssinus.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with allergic rhinoconjunctivitis with or without asthma against DPT during a
             minimum of 1 year prior to study participation.

          2. Patients must sign the informed consent form.

          3. Patients must be between 18 and 60 years of age.

          4. Patients who obtained a prick test result greater or equal to 3 mm diameter and a
             specific IgE greater or equal to class 2 (CAP/PHADIA) to DPT.

          5. Patients will preferably be monosensitized to DPT. In the case of polysensitized
             patients they can only be included if other sensitizations are caused by seasonal
             allergens whose pollination do not overlap with the study period.

          6. Women of childbearing potential must have a negative urine pregnancy test at Screening
             visit/Visit 0

          7. Women of childbearing potential must agree to use an appropriate contraception method
             during the study if they are sexually active

        Exclusion Criteria:

          1. Stable and continued use of medication for allergic pathology during 2 weeks prior to
             inclusion.

          2. Patients sensitised to other perennial allergens clinically relevant and with specific
             IgE levels greater or equal to class 2 CAP/PHADIA.

          3. Patients who received immunotherapy in the previous 5 years for DPT or for any
             allergen with cross reactivity or patients that are currently receiving immunotherapy
             for any allergen.

          4. Patients with severe asthma or FEV1 minor than 70% or asthma requiring inhaled or
             systemic corticoid treatment at the time of study entry or within 8 weeks prior to
             treatment initiation.

          5. Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical
             condition that the investigator deems relevant so as to interfere with the study.

          6. Patients with a previous history of anaphylaxis

          7. Patients with chronic urticaria

          8. Patients with unstable angina

          9. Patients with uncontrolled hypertension

         10. Patients with clinically significant arrythmias

         11. Patients with neoplasia

         12. Patients with clinically relevant malformations of the upper respiratory tract.

         13. Other chronic or immunological disease that could interfere with the assessment of the
             investigational product or that could generate any additional risk for the patients

         14. Patients who have participated in another clinical trial within 3 month prior to
             enrolment.

         15. Patients under treatment with tricyclic antidepressives, psychotropics beta-blockers,
             or Angiotensin Converting Enzyme Inhibitors (ACEI)

         16. Female patients who are pregnant or breast-feeding or women of childbearing potential
             that do not agree to use an appropriate contraception method during the study if they
             are sexually active, if they have not been surgically sterilised or present any other
             incapacity to bear

         17. Patient who does not attend the visits

         18. Patient's lack of collaboration or refusal to participate