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Multicenter Trial of Immunotherapy With House Dust Mite Allergoid (ACRI)
This study is ongoing, but not recruiting participants.
First Received: October 5, 2007   Last Updated: October 14, 2008   History of Changes
Sponsored by: Allergopharma Joachim Ganzer KG
Information provided by: Allergopharma Joachim Ganzer KG
ClinicalTrials.gov Identifier: NCT00540631
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Aluminum hydroxide Algeldrate Aluminum
U.S. FDA Resources

Further study details as provided by Allergopharma Joachim Ganzer 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: October 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
P: No Intervention
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
A: Experimental
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540631

Locations
Germany
Allergopharma Joachim Ganzer KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma Joachim Ganzer KG
Investigators
Principal Investigator: Herbert Riechelmann, MD University Ulm, Germany
  More Information

Additional Information:
leader in specific allergy research and therapy  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Allergopharma Joachim Ganzer KG, Clinical Development ( Anja Menzel, Dr.med. )
Study ID Numbers: AL0106ac
Study First Received: October 5, 2007
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00540631     History of Changes
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma Joachim Ganzer KG:
House Dust Mite Allergen
Aluminium hydroxide-adsorbed

Study placed in the following topic categories:
Immunologic Factors
Eye Diseases
Adjuvants, Immunologic
Asthma
Antacids
 Rhinitis
Conjunctivitis
Conjunctival Diseases
Aluminum Hydroxide

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

ClinicalTrials.gov processed this record on August 28, 2009



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