Chronic Urticaria
Conditions
Brief summary
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
Interventions
OTHERNon Interventional Study
Non Interventional Study
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CU-Quality of Life Questionnaire Score | Last 15 days before each visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dermatology Life Quality Index (DLQI). | Last 7 days before each visit | 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 |
| Urticaria Activity Score for 7 days (UAS7) | Last 7 days before each visit | 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 |
| Angioedema Quality of Life Questionnaire (AE-QoL) | Last 4 weeks before each visit | 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) |
| Urticaria Control Test (UCT) | Last 4 weeks before each visit | Short questionnaire assessing how well the urticaria symptoms were controlled over the last 4 weeks |
| 6-item Work Productivity and Activity Impairment (WPAI) instrument | Last 7 days before each visit | Respondents are asked questions about work and activity impairment due to health problems |
| Angioedema Activity Score (AAS) | Last 24 hours before each visit | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in the type of CU (spontaneous, inducible, or both) and the types of inducible urticaria | Every 3 months, for 24 months | As per physician judgment |
| Patient demographics | At the baseline | Information like: (age, gender) and physical characteristics (height, weight). |
| Patient satisfaction with treatment as assessed on a simple 0-10 VAS scale | Every 3 months, for 24 months | simple VAS scale where '0' corresponds to poorly satisfy and '10' corresponds to highly satisfy |
| CU history including the method of diagnosis | At the baseline | 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. |
| The presence of angioedema at baseline and during the course of the study (incidence and number of events). | Every 3 months, for 24 months | 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 |
| Previous and concomitant CU treatments including treatment adjustments during the course of the study. | Every 3 months, for 24 months | Concomitant medications |
| Patient-reported use of CU-related health care resources | Every 3 months, for 24 months | Including hospitalizations (frequency and duration), emergency room visits (frequency), planned and unplanned visits to a physician (frequency), and phone calls. |
| Incidence of spontaneous disease remission and the time to spontaneous remission | Every 3 months, for 24 months | As per physician judgment |
| Proportion of patients responding to each class of therapy | Every 3 months, for 24 months | As per physician judgment |
Countries
Argentina, Brazil, Colombia, Costa Rica, Dominican Republic, Guatemala, Honduras, Panama, Peru
Outcome results
None listed