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Spontaneous chronic urticaria (UCS) is a disease that affects 1% of the general population with a potentially severe impact on quality of life. Most patients respond favorably to long-term antihistamine treatment, but sometimes it is necessary to give a high dose (4 times the formal dose, Berlin consensus 2016). These high doses are often accompanied by side effects requiring cessation of treatment. The therapeutic alternative is then omalizumab, an expensive biotherapy. UCS is secondary to non-specific mast cell activation. It has been shown to be associated with activation of fibrinolysis that correlates with the severity of symptoms. Patients with UCS resistant to levocetirizine were shown to have higher D-dimer levels than patients who responded to antihistamines. Tranexamic acid is a molecule with antifibrinolytic propertiesSeveral cases of severe chronic urticaria responding favorably to treatment with tranexamic acid have been reported. In our department, Investigators also noticed the improvement of some of their patients on tranexamic acid. The combination of these two treatments appears to be synergistic: action on histamine receptors and control of fibrinolysis.
The investigators propose to evaluate the association of tranexamic acid and levocetirizine for the treatment of chronic spontaneous urticaria.
Multicentric controlled randomized crossover study, double-blind To evaluate the efficacy and safety of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine 20mg / day alone in the chronic treatment of chronic urticaria evaluated at 4 weeks.
A hierarchical analysis will be implemented in the following order:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Association drugs | Active Comparator | levocetirizine 10mg/day + tranexamic acid (AT) 2g/day for a month |
|
| one drug | Active Comparator | Levocetirizine 20 mg/day for a month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| association of levocetirizine and tranexamic acid | Drug | levocetirizine 10 mg/day + tranexamic acid 2 g/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the Urticaria Activity Score 7 (UAS7) | Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. To calculate the score, the patient rates the number of papules and itching intensity from 0 to 3 daily for 7 days. 0 corresponds to no papules and no itching, 3 corresponds to more than 50 papules per 24h and intense itching that can cause daily life. This makes a score of 0 to 6 per day accumulated over 7 days, ranging from 0 to 42. | 28 days |
| Tolerance of the association tranexamic acid and levocetirizine | Number of adverse events | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the non-inferiority of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine alone 20mg / day in terms of efficacy on the Angioedema Activity Score (AAS) | Evolution of the AAS score between the beginning (J0) and the end (J28) of the end of treatment. The AAS score is a The AAS consists of 5 questions as well as an opening question. A score between 0 and 3 is assigned to every answer field. The question scores are summed up to an AAS day sum score, 7 AAS day sum scores to an AAS week sum score (AAS7). Accordingly, the minimum and maximum possible AAS scores are 0-15 (AAS day sum score), 0-105 (AAS7). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raouf ZOUGLECH, MDS | Contact | 4 76 76 78 38 | 0033 | rzouglech@chu-grenoble.fr |
| Tiphaine Montagnon | Contact | 4 76 76 68 14 | 0033 | tmontagnon@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laurence BOUILLET, PhD | Internal Medicine - University Hospital Grenoble-Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble-Alpes | Recruiting | Grenoble | 38043 | France |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Multicentric controlled randomized crossover study, double-blind
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Double blind
| Levocetirizine only | Drug | levocetirizine 20 mg/day |
|
| 28 days |
| Clinical characteristics of responders | Identify the clinical characteristics of responders to the combination rather than antihistamines alone. | 28 days |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |