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Study With High Dose PURETHAL Mites in Allergic Rhinitis/Rhinoconjunctivitis Patients | Clinical Trials | Clareo Health

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

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

NCT00973453•HAL Allergy

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

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

Allergologie HNO-Heilkunde

Schorndorf, Germany

Klinik für Dermatologie und Allergie, Krankenhaus Bad Cannstatt

Stuttgart, Germany

Key Dates

Start Date

August 1, 2009

Primary Completion Date

August 1, 2010

Completion Date

August 1, 2010

Last Updated

September 12, 2011

Enrollment

ACTUAL participants

Conditions

Allergic RhinitisAllergic Rhinoconjunctivitis

Interventions

PURETHAL Mites 20,000 AUeq/ml

DRUG

PURETHAL Mites 20,000 AUeq/ml

DRUG

PURETHAL Mites 20,000 AUeq/ml

DRUG

A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up

NCT06732414

Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a

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RECRUITINGNA

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

NCT05494346

Acute RhinitisNasal Obstruction+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT

Harnessing Digital Medicine to Improve Allergic Rhinitis Management in Primary Care (DMAR)

Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis