Rhinoconjunctivitis
Conditions
Keywords
House Dust Mite Allergen, Aluminium hydroxide-adsorbed
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
Interventions
BIOLOGICALspecific 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
Sponsors
Allergopharma GmbH & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Positive SPT * Positive EAST * Positive specific provocation test
Exclusion criteria
* Serious chronic diseases * other perennial allergies
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability and safety of treatments during the entire study period | 4 years |
| 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 | 2 years |
Countries
Germany
Outcome results
None listed