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

NCT00973453 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-09-12

No results posted yet for this study

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.

Conditions

  • Allergic Rhinitis
  • Allergic Rhinoconjunctivitis

Interventions

DRUG

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.

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.

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.

Sponsors & Collaborators

  • HAL Allergy

    lead INDUSTRY

Principal Investigators

  • Jörg Kleine-Tebbe, MD · UZDAA, Untersuchungszentrum Dermatologie, Allergologie und Asthma, Berlin, Germany

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00973453 on ClinicalTrials.gov