Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000934-11 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multicenter Immunotherapy House Dust Mite Allergoid
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU) | Biological | Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection
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
Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued |
| Measure | Description | 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 | November 2007 - February 2010 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the AUC of the SMS after one year to baseline. | 1 year | |
| Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline | 2 years | |
| Immunologic changes IgE, IgG1 and IgG4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Herbert Riechelmann, MD | University Ulm, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergopharma GmbH & Co. KG | Reinbek | 21465 | Germany |
Not provided
| Label | URL |
|---|---|
| leader in specific allergy research and therapy | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 2 years |
| Tolerability and safety of treatments during the entire study period | 4 years |