Chronic spontaneous urticaria
Conditions
Brief summary
The change in baseline to week 17 in UAS7 for patients exhibiting low total IgE (≤40 kU/L) and patients with high total IgE levels (>40 kU/L).
Detailed description
Disease control: Urticaria Control Test (UCT) score and change to baseline; Angioedema Activity Score (AAS), score and change to baseline, percentage of patients with a positive UCT and AAS, respectively, Disease-specific quality of life: Dermatological Quality of Life Index, (DLQI), score and change to baseline; Chronic Urticaria Quality of Life Questionnaire ( CU-Q2oL), score and change to baseline; Angioedema Quality of Life Questionnaire (AE-QoL), score and change to baseline), Responder rates regarding UAS7 and UCT (none-, partial-, complete response), Rescue medication use (H1-AH, oral glucocorticoids) (substance and/or substance class)
Sponsors
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in baseline to week 17 in UAS7 for patients exhibiting low total IgE (≤40 kU/L) and patients with high total IgE levels (>40 kU/L). | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control: Urticaria Control Test (UCT) score and change to baseline; Angioedema Activity Score (AAS), score and change to baseline, percentage of patients with a positive UCT and AAS, respectively, Disease-specific quality of life: Dermatological Quality of Life Index, (DLQI), score and change to baseline; Chronic Urticaria Quality of Life Questionnaire ( CU-Q2oL), score and change to baseline; Angioedema Quality of Life Questionnaire (AE-QoL), score and change to baseline), Responder rates regarding UAS7 and UCT (none-, partial-, complete response), Rescue medication use (H1-AH, oral glucocorticoids) (substance and/or substance class) | — |
Countries
Germany
Outcome results
None listed