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AWARE - Chronic Urticaria

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02435238
Collaborator
(none)
180
Enrollment
21
Locations
36.8
Actual Duration (Months)
8.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    180 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    AWARE: A World-wide Antihistamine-Refractory Chronic Urticaria Patient Evaluation
    Actual Study Start Date :
    Sep 3, 2014
    Actual Primary Completion Date :
    Sep 27, 2017
    Actual Study Completion Date :
    Sep 27, 2017

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. To record use of clinical resources [24 months]

      Measuring how often clinical resources (hospitalisations, frequency of visits) are used

    2. Previous, current and future medication [24 months]

      Recording medication use throughout the 24 months

    3. The disease burden of chronic urticaria [24 months]

      The "disease burden" (including impact on sleep and work productivity)

    4. Rates of spontaneous remission [24 months]

    5. 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)

    6. Co-morbidities of refractory CU patients [24 months]

    7. first onset of chronic urticaria [24 months]

      Time of first onset of the disease and number physicians consulted

    8. Number of patients with angiodema [24 months]

    9. Number of angioedema episodes during the observational phase [24 months]

    10. Prevalence of inducible urticaria [24 months]

      The number of patients in the study population that are diagnosed with inducible urticaria.

    11. Diagnosis of CSU [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    -

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02435238
    Other Study ID Numbers:
    • CIGE025EGB01
    First Posted:
    May 6, 2015
    Last Update Posted:
    Feb 15, 2018
    Last Verified:
    Feb 1, 2018
    Additional relevant MeSH terms:
    Urticaria
    Chronic Urticaria

    Study Results

    No Results Posted as of Feb 15, 2018