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Completed

NCT Number: NCT02626221

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

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

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Key information

Conditions

Chronic Urticaria Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non interventional study

Other

Non Interventional Study

Primary outcomes

  1. Change in CU-Quality of Life Questionnaire Score

    Time frame: 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 outcomes

  1. Angioedema Quality of Life Questionnaire (AE-QoL)

    Time frame: 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)

  2. Change in Dermatology Life Quality Index (DLQI).

    Time frame: 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

  3. Urticaria Activity Score for 7 days (UAS7)

    Time frame: 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

  4. Angioedema Activity Score (AAS)

    Time frame: 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.

  5. Urticaria Control Test (UCT)

    Time frame: Last 4 weeks before each visit

    Short questionnaire assessing how well the urticaria symptoms were controlled over the last 4 weeks

  6. 6-item Work Productivity and Activity Impairment (WPAI) instrument

    Time frame: Last 7 days before each visit

    Respondents are asked questions about work and activity impairment due to health problems

Other outcomes

  1. Patient demographics

    Time frame: At the baseline

    Information like: (age, gender) and physical characteristics (height, weight).

  2. CU history including the method of diagnosis

    Time frame: 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.

  3. The presence of angioedema at baseline and during the course of the study (incidence and number of events).

    Time frame: 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

  4. Previous and concomitant CU treatments including treatment adjustments during the course of the study.

    Time frame: Every 3 months, for 24 months

    Concomitant medications

  5. Patient-reported use of CU-related health care resources

    Time frame: 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.

  6. Incidence of spontaneous disease remission and the time to spontaneous remission

    Time frame: Every 3 months, for 24 months

    As per physician judgment

  7. Proportion of patients responding to each class of therapy

    Time frame: Every 3 months, for 24 months

    As per physician judgment

  8. Changes in the type of CU (spontaneous, inducible, or both) and the types of inducible urticaria

    Time frame: Every 3 months, for 24 months

    As per physician judgment

  9. Patient satisfaction with treatment as assessed on a simple 0-10 VAS scale

    Time frame: Every 3 months, for 24 months

    simple VAS scale where '0' corresponds to poorly satisfy and '10' corresponds to highly satisfy

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: AWARE-LACan

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 10, 2015
Registry last updated
Dec 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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