NCT00973453

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: HAL Allergy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Rhinitis
• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-09-09
• Last updated: 2011-09-12

Locations

6 sites across 1 country: Germany