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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Allergic Rhinitis Allergic Rhinoconjunctivitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Slow regimen

Group Type OTHER

PURETHAL Mites 20,000 AUeq/ml

Intervention Type DRUG

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.

Intermediate regimen

Group Type OTHER

PURETHAL Mites 20,000 AUeq/ml

Intervention Type DRUG

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.

Fast regimen

Group Type OTHER

PURETHAL Mites 20,000 AUeq/ml

Intervention Type DRUG

Group 3: fast initial treatment (6+2 injections) Initial treatment: incremental weekly dose of 0.2, 0.4, 0.8, 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.

Interventions

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PURETHAL Mites 20,000 AUeq/ml

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.

Intervention Type DRUG

PURETHAL Mites 20,000 AUeq/ml

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.

Intervention Type DRUG

PURETHAL Mites 20,000 AUeq/ml

Group 3: fast initial treatment (6+2 injections) Initial treatment: incremental weekly dose of 0.2, 0.4, 0.8, 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.

Intervention Type DRUG

Other Intervention Names

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Immunotherapy for house dust mites allergy Immunotherapy for house dust mites allergy Immunotherapy for house dust mites allergy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No