AWARE - Chronic Urticaria

Novartis Pharmaceuticals180 enrolled

Overview

Non interventional study collecting patient reported outcomes. The study aims to assess the disease burden of chronic urticaria patients and to record the therapies used in daily clinical practice in the UK and the impact they have on the quality of life and work productivity of individual patients.

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Chronic Urticaria

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subjects must be 18 years old Subject must be willing and able to provide written informed consent for collection and analysis of routine data and PROs Subject must have medically confirmed diagnosis of chronic urticaria present for more than 2 months. Subject must be refactory to at least one H1 antihistamine Exclusion Criteria: Subjects who in the estimation of the treating physician are unlikely to be available for the full duration of the follow-up period of 24 months. Subjects taking must not take part in any other concurrent urticarial study. \-

Locations (21)

Novartis Investigative Site

Plymouth, Devon, United Kingdom

Novartis Investigative Site

Outcomes

Primary Outcomes

Measuring responses to PROs from patients on different treatments

Measuring quality of life, work productivity and changes in disease for patients on different treatment.

Time frame: 24 months

Secondary Outcomes

To record use of clinical resources

Measuring how often clinical resources (hospitalisations, frequency of visits) are used

Time frame: 24 months

Previous, current and future medication

Recording medication use throughout the 24 months

Time frame: 24 months

The disease burden of chronic urticaria

The "disease burden" (including impact on sleep and work productivity)

Time frame: 24 months

Rates of spontaneous remission

Time frame: 24 months

Treatment algorithms and trends

Measuring treatment algorithms and trends during the study course (including therapy adjustments and duration of use of each substance class)

Time frame: 24 months

Co-morbidities of refractory CU patients

Time frame: 24 months

first onset of chronic urticaria

Time of first onset of the disease and number physicians consulted

Time frame: 24 months

Number of patients with angiodema

Data from ClinicalTrials.gov

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