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Allergen specific immunotherapy is currently the only curative intervention for allergic rhinitis (AR). Subcutaneous immunotherapy (SCIT) need to be reinstituted with an interruption of more than 16 weeks in maintenance period, leading to increased time and economic cost burden and difficulties for continuing further treatment for patients. The aim of present study was to develop a novel dose adjustment schedule for such situation and to compare the clinical efficacy and adverse reactions between novel and conventional schedules for dust mite (DM) SCIT of AR subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel dose adjustment schedule | Experimental | The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with novel dose adjustment schedule. |
|
| Conventional dose adjustment | Active Comparator | The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with conventional dose adjustment schedule. |
|
| Continuous cluster SCIT schedule | Active Comparator | The subjects had a routine cluster SCIT schedule without interrupted period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel dose adjustment of Alutard SQ | Biological | novel dose adjustment schedule means directly reaching dose of Vial 4, 10,000 SQ |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of Combined Symptom and Medication Score | CSMS which was calculated as follows: (total nasal symptom scores (TNSS))/4+ MS as recommended by European Academy of Allergy and Clinical Immunology (EAACI) Position Paper. The CSMS score was 0-6, 0 for good therapeutic effect and 6 for poor therapeutic effect. | baseline, week 3, week 6, week 26. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of total nasal symptom scores | last 7 days' overall symptom scores of major nasal symptoms (nasal obstruction, nasal itching, sneezing, and rhinorrhea: 0, no symptoms; 1, mild; 2, moderate; 3, serious). TNSS scores was 0 to 12 (0 = no symptoms;12 = most severe symptoms). | baseline, week 3, week 6, week 26. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luo Zhang | Beijing Tongren Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Beijing | Beijing Municipality | 100730 | China |
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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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| conventional dose adjustment of Alutard SQ | Biological | conventional dose adjustment schedule means restarting from dose of Vial 1, 10 SQ |
|
| Routine continuous cluster of Alutard SQ | Biological | Patient receiving continuous cluster SCIT for DM during the same period |
|
| The change of medication score |
MS was calculated as follows: 1, oral Clarityne tablet; 2, intranasal Budesonide nasal spray. |
| Baseline, week 26. |
| Adverse reactions | The patients were instructed to immediately report to the physician if any symptom appeared or adverse reactions occurred during the observation period. The time and severity of onset, estimation of a possible reason, resolution, and outcome should be recorded. The adverse reactions were classified in terms of the localization (local or systemic) and the time of appearance (immediate or delayed). Local reactions (LRs) were expressed as the length of the wheal diameter. Systemic reactions (SRs) were graded in accordance with the standards of the EAACI | week 26. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |