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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00540631
First Posted: October 8, 2007
Last Update Posted: February 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
  Purpose
Multicenter Immunotherapy House Dust Mite Allergoid

Condition Intervention Phase
Rhinoconjunctivitis Biological: specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Allergopharma GmbH & Co. KG:

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 [ Time Frame: November 2007 - February 2010 ]

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

Enrollment: 108
Study Start Date: October 2007
Study Completion Date: December 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive SPT
  • Positive EAST
  • Positive specific provocation test

Exclusion Criteria:

  • Serious chronic diseases
  • other perennial allergies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540631


Locations
Germany
Allergopharma GmbH & Co. KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Herbert Riechelmann, MD University Ulm, Germany
  More Information

Additional Information:
Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00540631     History of Changes
Other Study ID Numbers: AL0106ac
2006-000934-11 ( EudraCT Number )
First Submitted: October 5, 2007
First Posted: October 8, 2007
Last Update Posted: February 11, 2013
Last Verified: February 2013

Keywords provided by Allergopharma GmbH & Co. KG:
House Dust Mite Allergen
Aluminium hydroxide-adsorbed

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents