Chronic Urticaria
Conditions
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Previous, current and future medication | 24 months | Recording medication use throughout the 24 months |
| The disease burden of chronic urticaria | 24 months | The disease burden (including impact on sleep and work productivity) |
| Rates of spontaneous remission | 24 months | — |
| 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) |
| Co-morbidities of refractory CU patients | 24 months | — |
| To record use of clinical resources | 24 months | Measuring how often clinical resources (hospitalisations, frequency of visits) are used |
| Number of patients with angiodema | 24 months | — |
| Number of angioedema episodes during the observational phase | 24 months | — |
| Prevalence of inducible urticaria | 24 months | The number of patients in the study population that are diagnosed with inducible urticaria. |
| Diagnosis of CSU | 24 months | — |
| first onset of chronic urticaria | 24 months | Time of first onset of the disease and number physicians consulted |
Countries
United Kingdom
Outcome results
None listed