NCT00540631

Multicenter Trial of Immunotherapy With House Dust Mite Allergoid

A Multicentre Randomized Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of a Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of House Dust Mite (Dermatophagoides Pteronyssinus) in Patients With Rhinitis/Rhinoconjunctivitis and/or Allergic Asthma Bronchiale

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Allergopharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Multicenter Immunotherapy House Dust Mite Allergoid

Detailed description

A multicentre randomized placebo-controlled double-blind clinical trial for evaluation of safety and efficacy of a specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of house dust mite (Dermatophagoides pteronyssinus) in patients with rhinitis/rhinoconjunctivitis and/or allergic asthma bronchiale

Conditions

• Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)	Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection 1. to be det. A 0.1 100 TU 2. 7 (+7) days later A 0.2 200 TU 3. 7 (+7) days later A 0.4 400 TU 4. 7 (+7) days later A 0.6 600 TU 5. 7 (+7) days later B 0.1 1000 TU 6. 7 (+7) days later B 0.2 2000 TU 7. 7 (+7) days later B 0.4 4000 TU 8. 7 (+7) days later B 0.6 6000 TU Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection 1. to be det. A 0.1 100 TU 2. 7 (+7) days later A 0.2 200 TU 3. 7 (+7) days later A 0.4 400 TU 4. 7 (+7) days later A 0.6 600 TU 5. 7 (+7) days later B 0.1 1000 TU 6. 7 (+7) days later B 0.2 2000 TU 7. 7 (+7) days later B 0.4 4000 TU 8. 7 (+7) days later B 0.6 6000 TU Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-08-01
• Completion: 2011-12-01
• First posted: 2007-10-08
• Last updated: 2013-02-11

Locations

1 site across 1 country: Germany