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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non immunotherapy treatment | No Intervention |
| |
| sublingual immunotherapy course | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunotherapy Staloral | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | three year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | three year |
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Inclusion Criteria:
Exclusion Criteria:
Patients with any of the following characteristics were excluded:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergology Outpatient Clinic | Zabrze | 41-800 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28668244 | Derived | Bozek A, Starczewska-Dymek L, Jarzab J. Prolonged effect of allergen sublingual immunotherapy for house dust mites in elderly patients. Ann Allergy Asthma Immunol. 2017 Jul;119(1):77-82. doi: 10.1016/j.anai.2017.05.012. | |
| 23331565 | Derived | Bozek A, Ignasiak B, Filipowska B, Jarzab J. House dust mite sublingual immunotherapy: a double-blind, placebo-controlled study in elderly patients with allergic rhinitis. Clin Exp Allergy. 2013 Feb;43(2):242-8. doi: 10.1111/cea.12039. |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |