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

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.
 
ClinicalTrials.gov Identifier: NCT00540631
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG

Tracking Information
First Submitted Date  ICMJE October 5, 2007
First Posted Date  ICMJE October 8, 2007
Last Update Posted Date February 11, 2013
Study Start Date  ICMJE October 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

  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

Study Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: November 2, 2012)
108
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2011
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00540631
Other Study ID Numbers  ICMJE AL0106ac
2006-000934-11 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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