Study With High Dose PURETHAL Mites in Allergic Rhinitis/Rhinoconjunctivitis Patients

HAL Allergy48 enrolled

Overview

The aim of the study is to establish the maximum tolerated dose of PURETHAL Mites that is achieved by 90% of the patients with less than 20% of the injections giving rise to a swelling of \> 5 cm and the optimal regimen to reach this maximum dose will be determined.

The tolerability and safety of three different initial treatment regimens PURETHAL mites in patients with allergic rhinitis / rhinoconjunctivitis induced by house dust mites will be evaluated and the optimal regimen to reach the maximum tolerated dose will be determined. The maximum intended dose is a 4-fold dosage compared to the currently used maintenance dose of PURETHAL Mites. The tolerability and safety of the injections will be examined by means of determining the early and late local and systemic reactions. In addition, short-term efficacy of this high dose PURETHAL mites will be determined by means of the Clinical index score (CIS) and two surrogate efficacy markers; the conjunctival provocation test (CPT) and serum levels of allergen specific immunoglobulins (IgG and IgE). These efficacy parameters are purely indicative and not decisive for the further clinical development of PURETHAL Mites.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Allergic Rhinitis Allergic Rhinoconjunctivitis

Interventions

PURETHAL Mites 20,000 AUeq/mlDRUG

Group 1: slow regimen (12+2 injections) Initial treatment: incremental weekly dose of 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.8, 1.0, 1.2\*, 1.6\* and 2.0\* ml Additional maintenance: 2 two-weekly injections 2.0\* ml \*Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm.

PURETHAL Mites 20,000 AUeq/mlDRUG

Group 2: intermediate regimen (9+2 injections) Initial treatment: incremental weekly dose of 0.1, 0.2, 0.4, 0.6, 0.8, 1.0, 1.2\*, 1.6\* and 2.0\* ml. Additional maintenance: 2 two-weekly injections 2.0\* ml \*Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm.

PURETHAL Mites 20,000 AUeq/mlDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with perennial rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 \> 70%) for at least 2 years. with allergic symptoms related to HDM 2. Positive CPT test to HDM Der p, dose ≤10,000 AUeq/ml 3. Positive SPT to HDM Der p or Der f (mean wheal diameter ≥ 3mm) 4. Specific serum IgE-test (ssIgE \> 0.7 U/ml) for HDM 5. Age ≥ 18 years 6. Written informed consent given Exclusion Criteria: 1. Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3 mm) to other allergens than HDM should not be included if they have clinical symptoms at the time of inclusion, related to the other allergen 2. Patients sensitized to pets should not be included if they live together with these pets or have clinical symptoms 3. Immunotherapy (including sublingual) with HDM within the last 5 years 4. Immunotherapy (including sublingual) during the study period 5. Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value or use of inhalation corticosteroids 6. Serious immuno-pathologic diseases or malignancies (including auto-immune diseases, tuberculosis) 7. Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension 8. Diseases with a contra-indication for the use of adrenaline 9. Patients who are using other aluminium preparations, e.g. antacids 10. Severe kidney disease 11. Use of systemic steroids 12. Treatment with systemic and local Beta-blockers or immunosuppressive drugs 13. Active infection of the target organs (nose or eyes) 14. Severe atopic dermatitis in case systemic immunosuppressive medication is used 15. Participation in a clinical study with a new investigational drug within the last 3 months 16. Pregnancy, lactation or inadequate contraceptive measures (adequate contraceptive measures will be the use of a contraceptive device or -pill) 17. Alcohol- or drug abuse 18. Lack of co-operation or severe psychological disorders 19. Institutionalisation by official or judicial order

Locations (6)

Allergie-Centrum Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité Campus Mitte, Universitätsmedizin Berlin

Berlin, Germany

Hals, Nasen- und Ohrenheilkunde

Berlin, Germany

Allergy & Asthma Center Westend

Berlin, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Outcomes

Primary Outcomes

Early Local Reactions (ELR) occurring 15 minutes after injection. Less than 20% of the injections should give rise to swelling at the injection site of > 5 cm in diameter occurring 15 minutes after injection.

Time frame: 17, 14 or 11 weeks per patient for the respective groups

Secondary Outcomes

Late Local Reactions (LLR) occurring within 24 hours after injection, and systemic reactions (SR). General adverse events will be recorded during complete study period.

Time frame: 17, 14 or 11 weeks per patient for the respective groups

Clinical index score (CIS) during the study compared to baseline score (before treatment).

Time frame: weekly during per patient treatment periods of 17, 14 or 11 weeks for the respective groups

Conjunctival provocation test one week after reaching 10,000 AUeq, 20,000 AUeq, or 40,000 AUeq for the respective groups compared to baseline.

Time frame: after 7 weeks of treatment

Conjunctival provocation test 2 weeks after the patients have received two maintenance dosages compared to baseline score.

Time frame: 17, 14 or 11 weeks for the respective treatment groups

Specific IgE and IgG measured 2 weeks after the patients have received two maintenance dosages compared to baseline score.

Time frame: 17, 14 or 11 weeks for the respective treatment groups

Data from ClinicalTrials.gov

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