Multicenter Trial of Immunotherapy With House Dust Mite Allergoid (ACRI)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergopharma GmbH & Co. KG

ClinicalTrials.gov Identifier:

NCT00540631

First received: October 5, 2007

Last updated: February 8, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 5, 2007

Last Updated Date

February 8, 2013

Start Date ^ICMJE

October 2007

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: November 2007 - February 2010 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00540631 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change of the AUC of the SMS after one year to baseline. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Immunologic changes IgE, IgG1 and IgG4 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Tolerability and safety of treatments during the entire study period [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Multicenter Trial of Immunotherapy With House Dust Mite Allergoid

Official Title ^ICMJE

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

Brief 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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Rhinoconjunctivitis

Intervention ^ICMJE

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

Study Arm (s)

No Intervention: P
subcutaneous treatment with placebo Placebo- physiological saline containing histamine-dihydrochloride 0.1mL, 0.2mL, 0.4mL, 0.6mL of strength A(1000TU/mL) followed by 0.1mL, 0.4mL, 0.6mL by strength B (10000TU/mL) in weekly intervals
Experimental: A
Active treatment with house dust mite extract

Intervention: Biological: specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

108

Completion Date

December 2011

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Positive SPT
Positive EAST
Positive specific provocation test

Exclusion Criteria:

Serious chronic diseases
other perennial allergies

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00540631

Other Study ID Numbers ^ICMJE

AL0106ac, 2006-000934-11

Has Data Monitoring Committee

Responsible Party

Allergopharma GmbH & Co. KG

Study Sponsor ^ICMJE

Allergopharma GmbH & Co. KG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Herbert Riechelmann, MD

University Ulm, Germany

Information Provided By

Allergopharma GmbH & Co. KG

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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