AWARE - Chronic Urticaria

Chronic Urticaria Clinical Trial

— AWARE  

Official title:

AWARE: A World-wide Antihistamine-Refractory Chronic Urticaria Patient Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435238
• Other study ID #: CIGE025EGB01
• Status: Completed
• Phase: N/A
• First received: December 2, 2014
• Last updated: February 14, 2018
• Start date: September 3, 2014
• Est. completion date: September 27, 2017

Study information

• Verified date: February 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 27, 2017
• Est. primary completion date: September 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Urticaria
• Urticaria

Locations

Country	Name	City	State
United Kingdom	Novartis Investigative Site	Belfast
United Kingdom	Novartis Investigative Site	Belfast
United Kingdom	Novartis Investigative Site	Cardiff
United Kingdom	Novartis Investigative Site	Chester
United Kingdom	Novartis Investigative Site	Coventry	Warwickshire
United Kingdom	Novartis Investigative Site	Darlington	Durham
United Kingdom	Novartis Investigative Site	Durham
United Kingdom	Novartis Investigative Site	East Yorkshire
United Kingdom	Novartis Investigative Site	Kent
United Kingdom	Novartis Investigative Site	Leeds
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	Leytonstone	London
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Middlesborough
United Kingdom	Novartis Investigative Site	Plymouth	Devon
United Kingdom	Novartis Investigative Site	Poole
United Kingdom	Novartis Investigative Site	Salford	Manchester
United Kingdom	Novartis Investigative Site	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

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