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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings