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Urticaria clinical trials

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NCT ID: NCT01713725 Completed - Chronic Urticaria Clinical Trials

Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria

Start date: March 2012
Phase: Phase 2
Study type: Interventional

Chronic urticaria can be defined as the occurrence of widespread daily or almost daily wheals for at least 6 weeks, which may be accompanied by angioedema. While the wheals are transient, the resolution of angioedema is slower than wheals and could take up to 72 hours. The natural course of chronic urticaria is self-limited, with spontaneous remissions and occasional relapses. The investigators calculated a 0.6% (95% CI(Confidence Interval): 0.4-0.8) prevalence in a population study. It has a great impact on patients' quality of life. In a recent national survey on patients attending Allergy Department, chronic urticaria was the disease with greater impact on mental quality of life out of all allergic diseases. In spite of the high morbidity of this disease and the impact in quality of life, there is no available treatment. Last guidelines recommend initiating treatment with antihistamine and if there is no response to increase the dose off-label up to four-fold; systemic corticosteroids are also recommended in short tapering and if no response, the only treatment with clinical evidence to be employed is cyclosporine. As additional data, the treatment cost of this disease has been calculated in 2047$/year. In past years it has been employed the monoclonal humanized anti-Immunoglobulin IgE (iGE) antibody (Omalizumab) to treat moderate to severe asthma with good results. The rationale for this approach in chronic urticaria is that Omalizumab inhibits the binding of IgE to the high affinity IgE receptor (FceRI) which decreases the FceRI expression on the surface of mast cells and basophils so that immunoglobulin G cross linking of the alpha subunit and basophil degranulation is prevented.The hypothesis the investigators are working on is that monoclonal IgE antibody Omalizumab could be effective in controlling chronic urticaria symptoms in patients non respondent to conventional therapy. The investigators hypothesize that Omalizumab is able to revert the basophil or mast cell activation present in chronic urticaria.

NCT ID: NCT01701583 Completed - Chronic Urticaria Clinical Trials

Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria

Start date: April 2013
Phase: Phase 4
Study type: Interventional

This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.

NCT ID: NCT01637116 Completed - Clinical trials for Autoreactive, Non-autoimmune Chronic Spontaneous Urticaria

Profiling Urticaria for the Identification of Subtypes

PURIST
Start date: July 2011
Phase: N/A
Study type: Observational

The primary purpose of this study is to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria. Additional aims: include the comparison of the clinical profiles of autoreactive, autoimmune and non autoreactive / autoimmune urticaria and the quality of life impairment in these subsets of chronic spontaneous urticaria.

NCT ID: NCT01614834 Completed - Chronic Urticaria Clinical Trials

Validation of an Urticaria Control Test

UCT-V
Start date: July 2012
Phase: N/A
Study type: Observational

The aim of this study is to validate a previously developed patient reported outcome instrument (in project UCT-D) to assess disease control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.

NCT ID: NCT01610128 Completed - Chronic Urticaria Clinical Trials

Development of an Urticaria Control Test

UCT-D
Start date: October 2011
Phase: N/A
Study type: Observational

The aim of the project is to develop a patient reported outcome instrument to assess disease control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.

NCT ID: NCT01605487 Completed - Clinical trials for Cold Contact Urticaria

Study to Assess Efficacy, Safety and Mechanism of Rupatadine in Cold Urticaria

PAFCUTIII
Start date: June 2012
Phase: Phase 2
Study type: Interventional

Main objective of this study is to evaluate the efficacy of rupatadine in 20 mg and 40 mg doses in the development of symptoms of cold contact urticaria. For this purpose, a Peltier element-based electronic provocation device (TempTest®, emo systems GmbH, Berlin, Germany) will be used. This allows skin exposure to 12 different temperatures from 4 to 42 °C simultaneously in a standardized and reproducible way and thus the determination of individual temperature and/or stimulation time thresholds. In addition mediators related from activated must cells such as histamine, PAF, PGD2 should be identified in the period between the application of stimulus and the appearance of symptoms of cold urticaria and should be characterized qualitatively and quantitatively.

NCT ID: NCT01599637 Completed - Clinical trials for Chronic Idiopathic Urticaria

Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.

NCT ID: NCT01586091 Completed - Allergic Rhinitis Clinical Trials

Safety Study of Levocetirizine and Fexofenadine

LAWAF
Start date: February 2011
Phase: Phase 4
Study type: Interventional

This Study is to comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once daily with Fexofenadine 60 mg twice daily in the histamine induced wheal, flare and itch Response.

NCT ID: NCT01580592 Completed - Clinical trials for Cold Contact Urticaria

Cold Urticaria Treatment With Xolair

CUTEX
Start date: April 2012
Phase: Phase 2
Study type: Interventional

Urticaria is a very frequent skin condition characterised by transient wheal and flare type skin reactions associated with severe pruritus. Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized by the development of wheal and flare type skin reactions due to the release of histamine and other proinflammatory mast cell mediators following exposure of the skin to cold. Among all physical urticaria subtypes the frequency of CCU varies between 5.7% and 33.8% in different studies. Physical urticarias including CCU are known to severely impair the quality of life of affected patients. The treatment of choice in CCU, as well as in other inducible forms and spontaneous urticaria, are non-sedating H1 antihistamines. Recent data have shown that updosing of H1 blockers is significantly more effective in reducing symptoms in cold urticaria than standard-dose treatment. Thus, patients who cannot be sufficiently controlled with standard-dose antihistamines should receive high-dose H1 blockers up to 4 times the standard dose as recommended by the new international guidelines for the management of urticaria. Previous phase II studies in patients with chronic spontaneous urticaria have shown favorable results for the treatment with omalizumab (Xolair®). Proof-of-concept data from completed studies suggest that omalizumab improves urticaria in patients with chronic spontaneous urticaria who have failed treatment with H1 antihistamines as well as those who have failed treatment with a combination of H1 and H2 antihistamines and a leukotriene receptor antagonist. In addition, two case reports of patients with severe therapy refractory CCU treated with omalizumab reported a complete response with no urticarial symptoms after cold challenge. In summary, these data suggest that omalizumab may have a beneficial effect in the treatment of CCU.

NCT ID: NCT01444196 Completed - Urticaria Clinical Trials

Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria

AECUDATT
Start date: August 2009
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to assess the dosis of DL which is sufficient to inhibit cold urticaria symptoms.