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

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

This is a non-interventional, multi-country, Latin American study utilizing a prospective single-cohort design. Eligible CU patients will be enrolled in the study and will be followed for 24 months (± 6 weeks).

In accordance with the observational nature of the study, there will be no interventions or interference with the routine care of the patient which will be based solely on the clinical judgment of the treating physician. However, with respect to the frequency and schedule of assessments, the schedule included in Table 7-1 will be recommended.

The selection of the treatment for CU will be clearly separated from the decision to include the patient in the study, and will be made at the discretion of the treating physician in accordance with standard medical practice, the investigator's clinical judgment, and global urticarial guidelines.

In order to prevent selection bias, investigators should offer enrollment to all consecutive patients meeting study criteria, likely to be available for the full duration of the follow-up period of 24 months, and willing to participate in the study.

The overall objective of the study is to evaluate in real-life the CU disease burden, the current treatment patterns and the use of health care resources in patients refractory to H1-antihistamine treatment

Study Overview

• Status: Completed
• Conditions: Chronic Urticaria
• Intervention / Treatment: Other: Non Interventional Study

• Study Type: Observational
• Enrollment (Actual): 497

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425DKG
    • Novartis Investigative Site
  • Mendoza, Argentina, M5502EZA
    • Novartis Investigative Site
  • Salta, Argentina, 4400
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1062ABK
      • Novartis Investigative Site
    • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1425BEA
      • Novartis Investigative Site
    • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1114AAJ
      • Novartis Investigative Site
    • Lobos, Buenos Aires, Argentina
      • Novartis Investigative Site
  • Nueve De Julio
    • Buenos Aires, Nueve De Julio, Argentina, B6500BWQ
      • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000BRH
      • Novartis Investigative Site
    • Rosario, Santa Fe, Argentina, 2000
      • Novartis Investigative Site
• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21941-913
      • Novartis Investigative Site
  • SP
    • Guarulhos, SP, Brazil, 07051-000
      • Novartis Investigative Site
    • Santo Andre, SP, Brazil, 09060-650
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 05437-000
      • Novartis Investigative Site
  • Sao Paulo
    • Alphaville / Barueri, Sao Paulo, Brazil, 06454-010
      • Novartis Investigative Site
• Colombia
  • Medellín, Colombia
    • Novartis Investigative Site
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Novartis Investigative Site
  • Atlantico
    • Barranquilla, Atlantico, Colombia
      • Novartis Investigative Site
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia
      • Novartis Investigative Site
• Costa Rica
  • San José, Costa Rica
    • Novartis Investigative Site
  • San Rafael Escazu, Costa Rica
    • Novartis Investigative Site
• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Novartis Investigative Site
  • Republica Dominicana
    • Santiago, Republica Dominicana, Dominican Republic
      • Novartis Investigative Site
    • Santo Domingo, Republica Dominicana, Dominican Republic
      • Novartis Investigative Site
• Guatemala
  • Guatemala City, Guatemala, 01010
    • Novartis Investigative Site
• Honduras
  • San Pedro Sula, Honduras, 21102
    • Novartis Investigative Site
  • San Pedro Sula, Honduras
    • Novartis Investigative Site
  • Tegucigalpa, Honduras
    • Novartis Investigative Site
• Panama
  • Panama, Panama
    • Novartis Investigative Site
• Peru
  • Lima
    • Jesus Maria, Lima, Peru, 11
      • Novartis Investigative Site
    • San Martin de Porres, Lima, Peru, 31
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible Latin American Chronic Urticaria adult patients, males and females, with at least one course of H1 antihistamines and is shown to be refractory to this treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single; Single Cohort Study	Other: Non Interventional Study; Non Interventional Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CU-Quality of Life Questionnaire Score	The CU-QoL is a validated instrument with established psychometric properties developed specifically for the assessment of the health burden of CU. The 2013 international CU guideline recommends the use of CU-Q2oL for assessing quality of life impairment and monitoring disease activity.	Last 15 days before each visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angioedema Quality of Life Questionnaire (AE-QoL)	For patients with angioedema, the symptom-specific quality of life will be assessed over the course of the study with the Angioedema Quality of Life Questionnaire (AE-QoL)	Last 4 weeks before each visit
Change in Dermatology Life Quality Index (DLQI).	A 10-item dermatology-specific health-related quality-of-life measure assessing dermatology symptoms and their impact on various aspects of life, during the course of the study	Last 7 days before each visit
Urticaria Activity Score for 7 days (UAS7)	Patients willing and able to comply with the UAS7 assessment will be given a paper-based urticaria diary at every site visit and be asked to complete it daily over the week preceding the next site visit. The diary consists of questions to evaluate the severity of their disease, and patients have to assess the severity of their disease, numbers of wheals and severity of itching	Last 7 days before each visit
Angioedema Activity Score (AAS)	The Angioedema Activitiy Score (AAS) is a validated, easy to use tool to determine disease activity in patients with recurrent angioedema, independent of its underlying causes. The AAS is designed to be used by patients for their daily documentation of swelling episodes including their duration, severity and impact on daily functioning and appearance.	Last 24 hours before each visit
Urticaria Control Test (UCT)	Short questionnaire assessing how well the urticaria symptoms were controlled over the last 4 weeks	Last 4 weeks before each visit
6-item Work Productivity and Activity Impairment (WPAI) instrument	Respondents are asked questions about work and activity impairment due to health problems	Last 7 days before each visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demographics	Information like: (age, gender) and physical characteristics (height, weight).	At the baseline
CU history including the method of diagnosis	Including diagnostic aids/tools used, ASST results), the time of onset of CU, the CU type (spontaneous, inducible or both), and the prevalence of inducible types of urticaria (e.g. cold, heat, light, aquagenic, cholinergic, contact), if applicable.	At the baseline
The presence of angioedema at baseline and during the course of the study (incidence and number of events).	Angioedema is typically characterized by: 1.-Sudden, pronounced swelling of the lower dermis and subcutis. 2.-Sometimes pain rather than itching. 3.-Frequent involvement below mucous membranes. 4.-Up to 72 hours for resolution	Every 3 months, for 24 months
Previous and concomitant CU treatments including treatment adjustments during the course of the study.	Concomitant medications	Every 3 months, for 24 months
Patient-reported use of CU-related health care resources	Including hospitalizations (frequency and duration), emergency room visits (frequency), planned and unplanned visits to a physician (frequency), and phone calls.	Every 3 months, for 24 months
Incidence of spontaneous disease remission and the time to spontaneous remission	As per physician judgment	Every 3 months, for 24 months
Proportion of patients responding to each class of therapy	As per physician judgment	Every 3 months, for 24 months
Changes in the type of CU (spontaneous, inducible, or both) and the types of inducible urticaria	As per physician judgment	Every 3 months, for 24 months
Patient satisfaction with treatment as assessed on a simple 0-10 VAS scale	simple VAS scale where '0' corresponds to poorly satisfy and '10' corresponds to highly satisfy	Every 3 months, for 24 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 24, 2014
• Primary Completion (ACTUAL): March 21, 2018
• Study Completion (ACTUAL): March 21, 2018

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (ESTIMATE): December 10, 2015

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Chronic Urticaria
• Other Study ID Numbers: CIGE025EVE01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com