Multicenter Trial of Immunotherapy With House Dust Mite Allergoid
NCT ID: NCT00540631
Last Updated: 2013-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2007-10-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
No interventions assigned to this group
A
Active treatment with house dust mite extract
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Positive EAST
* Positive specific provocation test
Exclusion Criteria
* other perennial allergies
18 Years
60 Years
ALL
No
Sponsors
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Allergopharma GmbH & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Herbert Riechelmann, MD
Role: PRINCIPAL_INVESTIGATOR
University Ulm, Germany
Locations
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Allergopharma GmbH & Co. KG
Reinbek, , Germany
Countries
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Related Links
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leader in specific allergy research and therapy
Other Identifiers
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2006-000934-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AL0106ac
Identifier Type: -
Identifier Source: org_study_id
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