Clinical Trial with subcutaneous polymerized depot innmunotherapy in patients with allergic rhinoconjunctivitis, sensitized to house dust mites.

Phase 1

• Conditions: The disease under study is allergic rhinoconjunctivitis secondary to sensitization to DPT and DF. Included in the study are patients diagnosed with that disease who also have associated mild asthma. The investigational drug is subcutaneous immunotherapy in polymerized depot presentation, containing a mixture of 50% DPT and DF extracts adsorbed onto 0.33% aluminium hydroxide.; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-002944-18-ES
• Lead Sponsor: Bial Industrial Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-08
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients who sign the informed consent sheet.
2. Patients between 18 and 60 years of age.
3. Patients with allergic rhinoconjunctivitis produced by their sensitivity to house dust mites: DPT and DF for at least one year before participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients with a mild concomitant asthmatic condition may also be included. Only patients with mild asthma can be admitted (Global Initiative for Asthma (GINA) 2015).
4. Patients preferably sensitized to both DPT and DF with symptoms which are clinically relevant to the exposure and, in the opinion of the clinical investigator, for whom treatment with a vaccine of 50% DPT and DF in polymerized depot is indicated.
5. Patients polysensitized to DPT and DF and also Lepidoglyphus destructor (LD), can be included, only in case, their level of specific IgE against at least one of the two dermatophagoides was at least double the level against LD.
6. Patients who present a positive nasal provocation test to DPT/DF at least one of the three concentrations of DPT/DF, tested at the beginning of the study. The negative control of this test must produce a consistent result.
7. Patients who have presented a skin-prick test result =3 mm in diameter for DPT and for DF. Both the negative and positive control of the test must produce consistent results.
8. Patients with a specific IgE value = class 2 (ImmunoCAP® System) for DPT and DF.
9. Women of childbearing age must present a negative urine pregnancy test at entry to the study (V0) and before administration of the first vaccine dose.
10. Also, the women at childbearing age (menarche), and the men participating in the study must agree to use a highly effective contraceptive method, according to (Clinical Trial Facilitation Group (CTFG) 2014), methods that can achieve a failure rate of less than 1% per year when used consistently and correctly.
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who have received prior immunotherapy in the preceding 5 years for any of the tested allergens or a cross-reactive allergen, or are currently receiving any allergen immunotherapy.
2. Patients with concomitant asthma who present a maximum expiratory volume in the first second of forced exhalation (FEV1) <70% of the predicted level at the time of inclusion, despite being controlled pharmacologically.
3. Polysensitized patients to other airborne allergens apart from Dermatophagoides pteronyssinus and Dermatophagoides farinae, who upon inclusion may present clinical symptoms which are relevant in the view of the investigator, and at the time of the nasal provocation test at the end of the trial.
4. Patients with immune, heart, kidney or liver diseases.
5. Patients with a history of anaphylaxis.
6. Patients with active chronic urticaria.
7. Patients with active severe atopic eczema.
8. Patients who participated in another clinical trial three months earlier.
9. Pregnant women or breastfeeding mothers.
10. Patients being treated with tricyclic antidepressants, phenothiazines, ß-blockers, and angiotensin converting enzyme inhibitors (ACE inhibitors).
11. Patients who cannot attend visits or, in the investigator's opinion, are unlikely to meet the study requirements.
12. Lack of collaboration or refusal to participate by the patient, or of another type deemed by the investigator to be of sufficient importance to interference with the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified