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

February 8, 2013 updated by: Allergopharma GmbH & Co. KG

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

Multicenter Immunotherapy House Dust Mite Allergoid

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Reinbek, Germany, 21465
        • Allergopharma GmbH & Co. KG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive SPT
  • Positive EAST
  • Positive specific provocation test

Exclusion Criteria:

  • Serious chronic diseases
  • other perennial allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
November 2007 - February 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of the AUC of the SMS after one year to baseline.
Time Frame: 1 year
1 year
Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline
Time Frame: 2 years
2 years
Immunologic changes IgE, IgG1 and IgG4
Time Frame: 2 years
2 years
Tolerability and safety of treatments during the entire study period
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergopharma GmbH & Co. KG

Investigators

  • Principal Investigator: Herbert Riechelmann, MD, University Ulm, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimate)

October 8, 2007

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL0106ac
  • 2006-000934-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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