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

Primary Purpose

Rhinoconjunctivitis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)
Sponsored by
Allergopharma GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinoconjunctivitis focused on measuring House Dust Mite Allergen, Aluminium hydroxide-adsorbed

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Positive SPT
  • Positive EAST
  • Positive specific provocation test

Exclusion Criteria:

  • Serious chronic diseases
  • other perennial allergies

Sites / Locations

  • Allergopharma GmbH & Co. KG

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

P

A

Arm Description

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

Active treatment with house dust mite extract

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of the AUC of the SMS after one year to baseline.
Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline
Immunologic changes IgE, IgG1 and IgG4
Tolerability and safety of treatments during the entire study period

Full Information

First Posted
October 5, 2007
Last Updated
February 8, 2013
Sponsor
Allergopharma GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT00540631
Brief Title
Multicenter Trial of Immunotherapy With House Dust Mite Allergoid
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergopharma GmbH & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoconjunctivitis
Keywords
House Dust Mite Allergen, Aluminium hydroxide-adsorbed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P
Arm Type
No Intervention
Arm Description
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
Arm Title
A
Arm Type
Experimental
Arm Description
Active treatment with house dust mite extract
Intervention Type
Biological
Intervention Name(s)
specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change of the AUC of the SMS after one year to baseline.
Time Frame
1 year
Title
Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline
Time Frame
2 years
Title
Immunologic changes IgE, IgG1 and IgG4
Time Frame
2 years
Title
Tolerability and safety of treatments during the entire study period
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive SPT Positive EAST Positive specific provocation test Exclusion Criteria: Serious chronic diseases other perennial allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Riechelmann, MD
Organizational Affiliation
University Ulm, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergopharma GmbH & Co. KG
City
Reinbek
ZIP/Postal Code
21465
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.allergopharma.de
Description
leader in specific allergy research and therapy

Learn more about this trial

Multicenter Trial of Immunotherapy With House Dust Mite Allergoid

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