A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation in Latin America and Canada (AWARE-LACan)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02626221
• Date of registration: 15/01/2015
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation in Latin America and Canada (AWARE-LACan) AWARE-LACan
• Scientific title: A Prospective Non-interventional Study to Collect Real Life Clinical Data on the Impact of Therapy, the Diagnosis and Management of Chronic Urticaria in Patients Refractory to at Least One Course of H1 Antihistamine Therapy
• Date of first enrolment: December 24, 2014
• Target sample size: 497
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02626221
• Study type: Observational [Patient Registry]

Countries of recruitment

Argentina, Brazil, Colombia, Costa Rica, Dominican Republic, Guatemala, Honduras, Panama, Peru

Key inclusion & exclusion criteria

Inclusion Criteria:

Men or Women at least 18 years of age or older. Patient has medically confirmed diagnosis
of chronic urticaria present for more than 2 months.

Patient has been treated with at least one course of H1 antihistamines and is refractory to
this treatment Patient has provided written informed consent allowing the use of their
anonymous data for the purposes of the study

Exclusion Criteria:

Patient is currently participating in a clinical trial. Patient is, in the opinion of the
treating physician, unlikely to be available for the full duration of the follow-up period
of 24 months



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Urticaria

Intervention(s)

Other: Non Interventional Study

Primary Outcome(s)

Change in CU-Quality of Life Questionnaire Score [Time Frame: Last 15 days before each visit]

Secondary Outcome(s)

Urticaria Activity Score for 7 days (UAS7) [Time Frame: Last 7 days before each visit]

6-item Work Productivity and Activity Impairment (WPAI) instrument [Time Frame: Last 7 days before each visit]

Urticaria Control Test (UCT) [Time Frame: Last 4 weeks before each visit]

Angioedema Activity Score (AAS) [Time Frame: Last 24 hours before each visit]

Angioedema Quality of Life Questionnaire (AE-QoL) [Time Frame: Last 4 weeks before each visit]

Change in Dermatology Life Quality Index (DLQI). [Time Frame: Last 7 days before each visit]

Secondary ID(s)

CIGE025EVE01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors