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NCT00540631 Clinical Trial

Multicenter Trial of Immunotherapy With House Dust Mite Allergoid

Rhinoconjunctivitis Clinical Trial

— ACRI  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00540631
Other study ID # AL0106ac
Secondary ID 2006-000934-11
Status Completed
Phase Phase 3
First received October 5, 2007
Last updated February 8, 2013
Start date October 2007
Est. completion date December 2011

Study information
Verified date February 2013
Source Allergopharma GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

Multicenter Immunotherapy House Dust Mite Allergoid

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

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date December 2011
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Positive SPT

- Positive EAST

- Positive specific provocation test

Exclusion Criteria:

- Serious chronic diseases

- other perennial allergies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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 to be det. A 0.1 100 TU 7 (+7) days later A 0.2 200 TU 7 (+7) days later A 0.4 400 TU 7 (+7) days later A 0.6 600 TU 7 (+7) days later B 0.1 1000 TU 7 (+7) days later B 0.2 2000 TU 7 (+7) days later B 0.4 4000 TU 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 to be det. A 0.1 100 TU 7 (+7) days later A 0.2 200 TU 7 (+7) days later A 0.4 400 TU 7 (+7) days later A 0.6 600 TU 7 (+7) days later B 0.1 1000 TU 7 (+7) days later B 0.2 2000 TU 7 (+7) days later B 0.4 4000 TU 7 (+7) days later B 0.6 6000 TU Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued

Locations
Country Name City State
Germany Allergopharma GmbH & Co. KG Reinbek

Sponsors (1)
Lead Sponsor Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary endpoint is the change of the area under the curve (AUC)of the Symptom-Medication-Score (SMS)after 2 years of double-blind treatment to baseline November 2007 - February 2010 Yes
Secondary Change of the AUC of the SMS after one year to baseline. 1 year Yes
Secondary Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline 2 years No
Secondary Immunologic changes IgE, IgG1 and IgG4 2 years No
Secondary Tolerability and safety of treatments during the entire study period 4 years Yes
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