Chronic Spontaneous Urticaria (CSU)
Conditions
Brief summary
• Change in itch score (Uniform Assessment System [UAS] as compared to placebo at each timepoint on exacerbation days • Change in hive score (UAS) as compared to placebo at each timepoint on exacerbation days
Detailed description
• Time to a 1-point decrease in itch and hive scores (UAS) • Time to a 2-point decrease in itch and hive scores (UAS) • Time to resolution • Time to recurrence within 24 hours, • Time to a 1-point decrease in itch and hive scores (UAS) • Time to a 2-point decrease in itch and hive scores (UAS) • Time to resolution • Time to recurrence within 24 hours, • Time to return to resolution by patient-rated visual analog scale (VAS) • Time to recurrence of symptoms within 24 hours • Change in pain (VAS) • Change in size of angioedema based on photographs, • Adverse events (AEs)
Interventions
DRUGEPINEPHRINE NASAL SPRAY
DRUGPlacebo Nasal Spray
Sponsors
Ars Pharmaceuticals IRL Limited
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Change in itch score (Uniform Assessment System [UAS] as compared to placebo at each timepoint on exacerbation days • Change in hive score (UAS) as compared to placebo at each timepoint on exacerbation days | — |
Secondary
| Measure | Time frame |
|---|---|
| • Time to a 1-point decrease in itch and hive scores (UAS) • Time to a 2-point decrease in itch and hive scores (UAS) • Time to resolution • Time to recurrence within 24 hours, • Time to a 1-point decrease in itch and hive scores (UAS) • Time to a 2-point decrease in itch and hive scores (UAS) • Time to resolution • Time to recurrence within 24 hours, • Time to return to resolution by patient-rated visual analog scale (VAS) • Time to recurrence of symptoms within 24 hours • Change in pain (VAS) • Change in size of angioedema based on photographs, • Adverse events (AEs) | — |
Countries
Germany
Outcome results
None listed