AWARE - Chronic Urticaria (AWARE)

February 14, 2018 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Novartis Investigative Site
      • Belfast, United Kingdom, BT12 6BA
        • Novartis Investigative Site
      • Cardiff, United Kingdom, CF14 4XW
        • Novartis Investigative Site
      • Chester, United Kingdom, CH2 1UL
        • Novartis Investigative Site
      • Durham, United Kingdom, DH1 6TW
        • Novartis Investigative Site
      • East Yorkshire, United Kingdom, HU16 5JQ
        • Novartis Investigative Site
      • Kent, United Kingdom, CT9 4AN
        • Novartis Investigative Site
      • Leeds, United Kingdom, LS9 7PN
        • Novartis Investigative Site
      • Leicester, United Kingdom, LE1 5WW
        • Novartis Investigative Site
      • Liverpool, United Kingdom, L14 3PE
        • Novartis Investigative Site
      • London, United Kingdom, SE18 4QH
        • Novartis Investigative Site
      • Manchester, United Kingdom, M13 9WL
        • Novartis Investigative Site
      • Manchester, United Kingdom, M23 9LT
        • Novartis Investigative Site
      • Middlesborough, United Kingdom, TS4 3BW
        • Novartis Investigative Site
      • Poole, United Kingdom, BH15 2JB
        • Novartis Investigative Site
      • Sheffield, United Kingdom, S5 7AU
        • Novartis Investigative Site
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Novartis Investigative Site
    • Durham
      • Darlington, Durham, United Kingdom, DL3 6HX
        • Novartis Investigative Site
    • London
      • Leytonstone, London, United Kingdom, E11 1NR
        • Novartis Investigative Site
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Novartis Investigative Site
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV2 2DX
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic Urticaria Patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring responses to PROs from patients on different treatments
Time Frame: 24 months
Measuring quality of life, work productivity and changes in disease for patients on different treatment.
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2014

Primary Completion (Actual)

September 27, 2017

Study Completion (Actual)

September 27, 2017

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIGE025EGB01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Urticaria

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe