AWARE - Chronic Urticaria

Completed

• Conditions: Chronic Urticaria

• Registration Number: NCT02435238
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-03
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-06
• Primary Completion: 2017-09-27
• Study Completion: 2017-09-27
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measuring responses to PROs from patients on different treatments	24 months	Measuring quality of life, work productivity and changes in disease for patients on different treatment.

Secondary Outcome Measures

Name	Time	Method
To record use of clinical resources	24 months	Measuring how often clinical resources (hospitalisations, frequency of visits) are used
Previous, current and future medication	24 months	Recording medication use throughout the 24 months
Rates of spontaneous remission	24 months
Co-morbidities of refractory CU patients	24 months
first onset of chronic urticaria	24 months	Time of first onset of the disease and number physicians consulted
Number of angioedema episodes during the observational phase	24 months
Diagnosis of CSU	24 months
Treatment algorithms and trends	24 months	Measuring treatment algorithms and trends during the study course (including therapy adjustments and duration of use of each substance class)
Prevalence of inducible urticaria	24 months	The number of patients in the study population that are diagnosed with inducible urticaria.
The disease burden of chronic urticaria	24 months	The "disease burden" (including impact on sleep and work productivity)
Number of patients with angiodema	24 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Sheffield, United Kingdom