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.
Conditions
Interventions
Product Name: 1-day polymerized depot Allergovac
Product Code: V01AA
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: DERMATOPHAGOIDES PTERONYSSINUS
Other descriptive name: DERMATOPH
Sponsors
Bial Industrial Farmacéutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical efficacy of immunotherapy by changing the concentration of the allergen (DPT- DF) required to produce a positive response in the nasal provocation test between the screening visit (V0) and the final visit (FV) of the study. Differences in this variation will be compared between the different treatment groups versus placebo.;Secondary Objective: To estimate the clinical efficacy of immunotherapy through the change in the mean symptom score after conducting the nasal provocation test between the V0 and FV. To evaluate the percentage of responder patients, without change patients and non-responder patients. To determinate the clinical efficacy of immunotherapy through the change in the average score in the scale visual analogic of rhinoconjunctivitis symptoms after receiving immunotherapy for six maintenance months, between the V0 and the FV. To establish the indirect efficacy of immunotherapy by measuring changes in levels of specific sIgE, total specific sIgG and specific sIgG4. To evaluate the indirect efficacy of immunotherapy through the reduction in the size of wheal by conducting the dose-response skin-prick test. To analyse the safety and tolerability of two doses of subcutaneous immunotherapy in polymerized depot. To analyze relevant variations in analytical results between visit 0 and the final visit.;Primary end point(s): The primary endpoint of the study is the change in the concentration of the allergen (DPT- DF) required to produce a positive response in the nasal provocation test between the screening visit (V0) and the final visit (FV) of the study. Differences in this variation between the different treatment groups will be compared and with the placebo group too.;Timepoint(s) of evaluation of this end point: 28 weeks (25+3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The change in the mean symptom score after conducting the nasal provocation test between the baseline visit (V0) and the final visit (FV) of the study. This variation in the symptom score will be compared between different treatment groups and against the placebo group. • The percentage of responder patients, without change patients and non-responder patients. The firsts are whose after receiving immunotherapy for six maintenance months, presents an increase in the concentration of the allergen (DPT-DF) required to produce a positive response in the nasal provocation test between the selection visit (V0) and the final visit (FV), in each group. The latter are whose after receiving immunotherapy for six maintenance months, presents a decrease in the concentration of the allergen (DPT-DF) required to produce a positive response in the nasal provocation test between the selection visit (V0) and the final visit (FV) in each group. • The change in the average score in the scale visual analogic, (EVA) of rhinoconjunctivitis symptoms after receiving immunotherapy for six maintenance months, between the baseline visit (V0) and the final visit (FV). • Difference obtained in immunoglobulin levels: specific IgE, total IgG and specific IgG4 between V0 and VF. • Comparison of the differences obtained in the wheal size between V0 and the intragroup VF. • Number and percentage of adverse reactions by number of patients and doses received; recorded by both the patient and the medical staff responsible for providing the subcutaneous immunotherapy. • In addition, variations in analytical results estimated to be clinically relevant, at the discretion of each principal investigator, will be analysed and compared between visit 0 and the final visit.;Timepoint(s) of evaluation of this end point: 28 weeks (25+3) | — |
Countries
Portugal, Spain
Contacts
Public ContactMª Cruz Gómez
Bial Industrial Farmacéutica S.A.
Outcome results
None listed