Clinical trial NCT02435238: AWARE - Chronic Urticaria
Official title: AWARE: A World-wide Antihistamine-Refractory Chronic Urticaria Patient Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Urticaria
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Urticaria Patients

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.


Eligibility criteria: 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.

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Primary outcomes:
measure: Measuring responses to PROs from patients on different treatments
timeFrame: 24 months
Secondary outcomes:
measure: To record use of clinical resources
timeFrame: 24 months
measure: Previous, current and future medication
timeFrame: 24 months
measure: The disease burden of chronic urticaria
timeFrame: 24 months
measure: Rates of spontaneous remission
timeFrame: 24 months
measure: Treatment algorithms and trends
timeFrame: 24 months
measure: Co-morbidities of refractory CU patients
timeFrame: 24 months
measure: first onset of chronic urticaria
timeFrame: 24 months
measure: Number of patients with angiodema
timeFrame: 24 months
measure: Number of angioedema episodes during the observational phase
timeFrame: 24 months
measure: Prevalence of inducible urticaria
timeFrame: 24 months
measure: Diagnosis of CSU
timeFrame: 24 months
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Novartis Investigative Site
state: Devon
city: Darlington
country: United Kingdom
facility: Novartis Investigative Site
state: Durham
city: Leytonstone
country: United Kingdom
facility: Novartis Investigative Site
state: London
city: Salford
country: United Kingdom
facility: Novartis Investigative Site
state: Manchester
city: Coventry
country: United Kingdom
facility: Novartis Investigative Site
state: Warwickshire
city: Belfast
country: United Kingdom
facility: Novartis Investigative Site
city: Belfast
country: United Kingdom
facility: Novartis Investigative Site
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: Chester
country: United Kingdom
facility: Novartis Investigative Site
city: Durham
country: United Kingdom
facility: Novartis Investigative Site
city: East Yorkshire
country: United Kingdom
facility: Novartis Investigative Site
city: Kent
country: United Kingdom
facility: Novartis Investigative Site
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Middlesborough
country: United Kingdom
facility: Novartis Investigative Site
city: Poole
country: United Kingdom
facility: Novartis Investigative Site
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
References: