A Phase 4 interventional study of immunotherapy Staloral in Allergic Rhinitis, sponsored by Medical University of Silesia. Completed at 1 site in Poland. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-05-25.
Sponsored by Medical University of Silesia · Phase 4, Interventional, and Treatment
The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin prick tests, serum-specific IgE and nasal provocation tests were included. Patients were individually randomised to groups: active or placebo using a double-blind method. A total of 51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R, Stallergens, France) and 57 in the placebo group were monitored for three years. The patients had to record on a diary card whenever they used anti-allergic medications.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 111 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Medical University of Silesia is the lead sponsor of 111 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with any of the following characteristics were excluded:
Drug: immunotherapy Staloral
Drug: immunotherapy Staloral
Staloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months).
Number of participants with adverse event during immunotherapy
Safety assessment of sublingual immunotherapy on the basis of the monitoring clinical adverse events during treatment by the use of a patient diary and medical examination.
Time frame: three year
Change from baseline of nasal symptoms after immunotherapy
Assessment of reducing the need for symptom-targeted drugs, primarily antihistamines and reducing of nasal symptoms during treatment in study patients (diary monitoring).
Time frame: three year
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Medical University of Silesia