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Completed

NCT Number: NCT02435238

AWARE - Chronic Urticaria

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.

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Key information

Conditions

Chronic Urticaria Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Plymouth, Devon, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. To record use of clinical resources

    Time frame: 24 months

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

  2. Previous, current and future medication

    Time frame: 24 months

    Recording medication use throughout the 24 months

  3. The disease burden of chronic urticaria

    Time frame: 24 months

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

  4. Rates of spontaneous remission

    Time frame: 24 months

  5. 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)

  6. Co-morbidities of refractory CU patients

    Time frame: 24 months

  7. first onset of chronic urticaria

    Time frame: 24 months

    Time of first onset of the disease and number physicians consulted

  8. Number of patients with angiodema

    Time frame: 24 months

  9. Number of angioedema episodes during the observational phase

    Time frame: 24 months

  10. Prevalence of inducible urticaria

    Time frame: 24 months

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

  11. Diagnosis of CSU

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: AWARE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 6, 2015
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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