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Urticaria clinical trials

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NCT ID: NCT02435238 Completed - Chronic Urticaria Clinical Trials

AWARE - Chronic Urticaria

AWARE
Start date: September 3, 2014
Phase: N/A
Study type: Observational

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.

NCT ID: NCT02424799 Completed - Urticaria Clinical Trials

Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264

Start date: November 17, 2014
Phase: Phase 1
Study type: Interventional

This First Time in Human (FTIH) study, which will be performed in three parts, is designed to investigate the safety, local tolerability, pharmacokinetics and pharmacodynamics after single and repeat topical applications of up to 2 strengths of GSK2646264 and corresponding placebo within the same subject, in healthy adult subjects (Part A), subjects with cold urticaria (CU, Part B) and subjects with chronic spontaneous urticaria (CsU, Part C). The study will also measure short term effects of GSK2646264 on the number and size of weals in subjects with CsU, and in healthy subjects and subjects with CU following provocation tests.

NCT ID: NCT02392624 Completed - Urticaria Clinical Trials

A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria

Start date: May 18, 2015
Phase: Phase 4
Study type: Interventional

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg) every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.

NCT ID: NCT02382562 Terminated - Depression Clinical Trials

Brief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients

Start date: May 2015
Phase: N/A
Study type: Interventional

Depression and other unhealthy behaviors, such as not taking medication as prescribed and not attending doctor visits have been suggested to increase the worsening of allergic diseases (e.g. asthma, urticaria). We intend to determine whether a one-session behavioral intervention is effective in helping with depression and controlling disease symptoms. We will measure this using pre- and post-intervention surveys.

NCT ID: NCT02372604 Completed - Clinical trials for Chronic Spontaneous Urticaria

Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria

LEVURE PLUS
Start date: July 2015
Phase: Phase 3
Study type: Interventional

Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of the cases, it lasts more than 2 years. It can dramatically alter the quality of life, in particular sleep, and generates numerous consultations and hospitalizations, with an average annual cost per patient close to 2000 euros in Europe. The treatment is based on the validated 2nd generation anti-H1 antihistamines dosage of one tablet per day whose effectiveness is satisfactory, however about half the time. In cases of severe CSU refractory to treatment with anti-H1 licensed dosage, few therapeutic alternatives exist, still off-label: the monketulast, an anti-leukotriene, ciclosporine or methotrexate, as immunosuppressants. Various studies have shown the important benefit of an expensive anti-IgE biological: the omaluzimab. Several open studies have also suggested superior efficacy and good tolerability of anti-H1 in higher dosage (double, triple or quadruple) including levocetirizine. The off-label use of these high dosages of anti-H1 is growing very rapidly in France, tending to replace the use of anti-H1 first generation or substitution to another 2nd generation anti-H1 recommended by the French Society of Dermatology. This study, under the aegis of the Urticaria Group of the French Society of Dermatology, intends to compare the efficacy of levocetirizine 4 tablets/day versus 1 tablet/day in the treatment of CSU resistant to anti-H1 licensed dosage.

NCT ID: NCT02358265 Terminated - Chronic Urticaria Clinical Trials

Chronic Urticaria - Long Term Assessment of Effects of Rupatadine

Start date: December 2014
Phase: Phase 3
Study type: Interventional

To compare CSU disease activity at the end of the follow up phase between patients that had been treated daily continuously vs. on-demand in the treatment phase

NCT ID: NCT02329223 Completed - Clinical trials for Chronic Spontaneous Uriticaria

Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients

Start date: December 2014
Phase: Phase 3
Study type: Interventional

This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.

NCT ID: NCT02285049 Completed - Chronic Urticaria Clinical Trials

Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Urticaria Control Test

Start date: November 2014
Phase: N/A
Study type: Observational

Chronic urticaria symptoms commonly fluctuate from day by day. Consequently the clinical presentation of a patient in each visit is not representative of the current disease status. Dermatologists are trying to integrate an evaluation process of each treatment visit regarding both clinical condition and life quality concern. The Urticaria Control Test is the key for a better treatment outcome in a routine management. To translate this questionnaire into Thai is essential in our subject of interest for offering local patients a higher well-being standard. The Thai-version test will encourage enhanced as well as impactful therapeutic options for Thai chronic urticaria patients.

NCT ID: NCT02285023 Completed - Chronic Urticaria Clinical Trials

The Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire

CU-Q2oL
Start date: November 2014
Phase:
Study type: Observational

In the majority of patients with the chronic urticaria, the etiology is unclear, leading to difficulties in treatment and high rates of recurrence. According to the International EAACI/GA2LEN/EDF/WAO Guidelines (the Dermatology Section of the European Academy of Allergology and Clinical Immunology(EAACI), the Global Allergy and Asthma European Network (GA2LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) in Urticaria, using the Chronic Urticaria Quality of Life Questionnaire in a routine management is the key for a better treatment outcome. To translate this questionnaire into Thai is essential in our subject of interest in order to effectively apply it to local patients. The Thai-version questionnaire will encourage enhanced as well as impactful therapeutic options for Thai chronic urticaria patients.

NCT ID: NCT02262130 Completed - Solar Urticaria Clinical Trials

Omalizumab in Severe and Refractory Solar Urticaria

XOLUS
Start date: September 30, 2014
Phase: Phase 2
Study type: Interventional

Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual treatment, leading to a large impact on quality of life. New treatment options are warranted. The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody recently approved in chronic spontaneous urticaria, in this setting.