A Phase 2 interventional study of Placebo and PURETHAL Mites 6,667 AU/ml in Allergic Rhinitis and Allergic Rhinoconjunctivitis, sponsored by HAL Allergy. Completed at 35 sites in 5 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-05-29.
Sponsored by HAL Allergy · Phase 2, Interventional, and Treatment
The objective of the present study is to characterize the dose-response relationship of PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms of clinical efficacy and safety.
For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of treatment and at the end of the study patients will be subjected to a nasal provocation test.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 290 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →HAL Allergy is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Placebo
Biological: PURETHAL Mites 6,667 AU/ml
Biological: PURETHAL Mites 20,000 AU/ml
Biological: PURETHAL Mites 50,000 AU/ml
Biological: PURETHAL Mites 100,000 AU/ml
Increasing volumes of placebo, will be administered by subcutaneous injection (starting with 0.05 ml) at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of placebo, are given at 4-weekly intervals.
Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
Sensitivity to House Dust Mite (HDM) allergen assessed by a Nasal Provocation Test
Time frame: 12 months
Sensitivity to HDM allergen assessed by a Nasal Provocation Test
Time frame: 6 months
Average Adjusted daily Symptom Score (AAdSS)
Time frame: last 2 months of treatment
Peak Nasal Inspiratory Flow (PNIF)
Time frame: at each visit during 1 year treatment
Specific serum IgE, IgG, and IgG4 immunoglobulin concentrations to house dust mite
Time frame: 6 and 12 months treatment
Local and systemic reactions after injection as a measure of Safety and Tolerability
Time frame: 24 hours after each injection during 1 year treatment
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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HAL Allergy