Evaluation of Prednisone and Antihistamine Combination Versus Antihistamine Monotherapy in Acute Urticaria Management in Emergency Department Settings

The primary objective of the study titled "COURAGE - Corticosteroid in acute urticaria in emergency department" is to demonstrate the **non-inferiority** of the efficacy of a single **antihistamine** compared to a combination of antihistamine and **corticosteroid** in the treatment of acute urticaria in emergency departments. This objective is clinically relevant as it seeks to evaluate whether a simpler treatment regimen can be as effective as the current standard, potentially reducing medication use and associated side effects in patients presenting with acute urticaria.

The clinical trial involves **adult patients** with isolated acute urticaria presenting to the emergency department. The study population includes both male and female participants over the age of 18, with no specific mention of a vulnerable population being selected. The sponsor has not provided the total number of participants. Participants were selected based on their presentation of acute urticaria with angioedema, excluding those with laryngeal edema. All participants were required to provide consent and have social security affiliation. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The study aims to evaluate the efficacy of a single antihistamine compared to a combination of antihistamine and corticosteroid in treating acute urticaria in emergency settings.

The clinical trial is designed to evaluate the **non-inferiority** of a single antihistamine compared to a combination of antihistamine and **corticosteroid** in the treatment of acute urticaria in emergency departments. This study employs a randomized, double-blind, controlled trial design to ensure the reliability and validity of the results. The trial is expected to span from September 21, 2019, to September 21, 2025, with participant involvement lasting up to 7 days. The primary endpoint is the 7-Days Urticaria Activity Score (UAS 7) assessed on day 7.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age over 18 years, presence of acute urticaria with angioedema without laryngeal edema, and consent to participate. Following the screening, participants will be randomized to receive either the active treatment, **prednisone** (CORTANCYL 20 mg), or a placebo. The study includes follow-up visits to monitor the participants' response to treatment and to collect data for the primary endpoint. The end-of-study visit will occur on day 7, where the final assessment of the UAS 7 will be conducted.

Participant involvement is expected to last for the duration of the trial, with the possibility of early termination if adverse events occur or if the participant withdraws consent. The trial is conducted under strict ethical guidelines, ensuring the safety and well-being of all participants. The study aims to provide valuable insights into the management of acute urticaria in emergency settings, potentially influencing future treatment protocols.

The clinical trial involves the administration of **CORTANCYL 20 mg**, a **tablet** formulation containing the active substance **prednisone**. Prednisone is a synthetic **corticosteroid** with anti-inflammatory properties, commonly used in the treatment of various inflammatory and autoimmune conditions. In this study, CORTANCYL is administered orally. The maximum daily dose is 120 mg, with a total maximum dose of 240 mg over the treatment period. The treatment duration is limited to a maximum of 4 days. The pharmaceutical product is manufactured by CHEPLAPHARM ARZNEIMITTEL GMBH and is authorized for use in France. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the prescribed regimen.

The study also includes a **placebo** group, which receives a placebo of CORTANCYL 20 mg. The placebo is designed to match the active treatment in appearance but does not contain any active pharmaceutical ingredients. The placebo serves as a comparator to evaluate the efficacy of the active treatment in the management of acute urticaria in emergency departments. The placebo is administered in the same manner as the active treatment, ensuring blinding of participants and investigators to the treatment allocation. Compliance with the placebo administration will be similarly monitored to maintain the integrity of the trial results.

Efficacy in the clinical trial titled "COURAGE - Corticosteroid in acute urticaria in emergency department" will be assessed using the primary endpoint of the **7-Days Urticaria Activity Score (UAS 7)** at day 7. This endpoint is designed to evaluate the effectiveness of a single antihistamine compared to a combination of antihistamine and corticosteroid in treating acute urticaria in emergency department settings. The UAS 7 is a validated scale that measures the severity and frequency of urticaria symptoms over a seven-day period, providing a comprehensive assessment of symptom improvement. Data collection for this endpoint will occur at the specified timepoint of day 7, ensuring a consistent and standardized approach to measuring treatment efficacy. The analysis will focus on demonstrating the non-inferiority of the single antihistamine treatment compared to the combination therapy, as outlined in the trial's main objective.