Chronic Spontaneous Urticaria
Conditions
Interventions
Treatment Group:Loratadine combined with histamine human immunoglobulin
Control Group:Loratadine combined with placebo
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1). Written informed consent must be obtained before any assessment is performed; 2). Age = 18 years; 3).Meet the diagnostic criterias of chronic spontaneous urticaria fromand follow the doctor's advice;the patient had urticaria symptoms in the previous week before enrollment, and UAS7 score(range 0-42) = 7; 4).Patients with uncontrolled urticaria are regularly treated with standard haplussed antihistamines for 2 weeks before screening;
Exclusion criteria
Exclusion criteria: 1).Pregnant or nursing (lactating) women; 2).Patients with malignant tumors, severe liver and kidney diseases, hematological disorders, autoimmune diseases(such as systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis, myositis, systemic vasculitis, systemic sclerosis, rheumatoid arthritis, spondyloarthropathy or other rheumatic immune diseases evaluated by the physician that are not suitable for inclusion), chronic serious infections, diabetic peripheral neuropathy, psychosis, and other diseases or medical histories that may affect normal efficacy evaluation and/or subject safety evaluation; 3).History of drug or alcohol abuse; 4).Patients who discontinue systemic use of glucocorticoids and other immunosuppressants(such as cyclosporin A, tripterygium wilfordis, etc.) that affect immune function for less than 4 weeks;Patients who discontinue systemic use of biologics (e.g., omalizumab) for less than 3 months; 5).Patients with symptoms of urticaria and/or angioedema, Including but not limited to urticaria vasculitis, seropathic reaction, bullous pemphigoid, mastocytosis, neutrophilic urticaria dermatosis, Schnitzler syndrome, autoinflammatory response syndromes (e.g., tumor necrosis factor receptor-associated periodic fever syndrome, familial Mediterranean fever, mevalate kinase deficiency, etc.); 6).Allergic to human immunoglobulin; 7).History of other severe allergic reactions; 8).Patients with pathological arrhythmias and a history of organic heart disease; Patients with known or suspected QT prolongation; or patients who are unable to discontinue medications that cause QT prolongation during the trial; 9).Subjects whom the investigator considers unsuitable for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate during the last week of treatment (i.e., proportion of patients with UAS7 score(range 0-42) < 7 for 7 consecutive days after the last injection); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time when UAS7 score (range 0-42) <7 for the first time;Changes in UAS7 scores(range 0-42) after each dose compared with baseline;Proportion of patients who responded to treatment as assessed by UCT score;Proportion of patients with well-controlled disease as assessed by UCT score;Change in CU-Q2oL score from baseline;Proportion of patients who developed respiratory infections; | — |
Countries
China
Contacts
Public ContactGuanKai
Peking Union Medical College Hospital
Outcome results
None listed