Estudio primario

No clasificado

Angioedema and angioedema management from Asteria I and Asteria II: phase III studies to evaluate the efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.

Año 2014
Autores Zazzali J , Rosen K , BradleyMS , Raimundo K.
Revista J Allergy Clin Immunol
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Estudio primario

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An exploratory phase III, randomised, double blind, therapeutic single dose-related effect, parallel group study to assess and compare the effects of 5mg vs. 20mg Desloratadine on skin lesions in patients with chronic urticaria (CU).

Año 2007
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Trade Name: Aerius Product Name: Desloratadine Product Code: SCH34117 Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

DESLORATADINE CAS Number: 100643‐71‐8 Other descriptive name: Aerius Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use

CONDITION:

Chronic urticaria is characterized by the spontaneous development of wheal and flare type skin reactions. ; MedDRA version: 9.1 Level: LLT Classification code 10009159 Term: Chronic urticaria ; MedDRA version: 9.1 Level: LLT Classification code 10009159 Term: Chronic urticaria

PRIMARY OUTCOME:

Main Objective: Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography. Primary end point(s): The main goal of the analysis is to test whether treatment with 20 mg Desloratadine (DL) is more effective in reducing the size, distribution and kinetics of urticaria lesions (wheal and flare) than 5 mg DL.; The primary efficacy parameter of the study is the assessment of the reduction in size of urticaria lesions (wheal and flare) by thermography (within a defined area and period of time). Secondary Objective: Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by digital time lapse photography.; Reduction in size of existing spontaneous urticaria lesions as assessed by volumetric analyses.; Reduction in size of new occuring spontaneous urticaria lesions (wheal and flare) as assessed by thermography.; Reduction in size of new occuring spontaneous urticaria lesions (wheal and flare) as assessed by digital time lapse photography.; Reduction in size of new occuring spontaneous urticaria lesions as assessed by volumetric analyses.; Reduction of urticaria symptoms.;

INCLUSION CRITERIA:

1. Outpatients with moderate to severe CU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch. 2. Patients must exhibit spontaneous urticaria lesions at the randomization visit. 3. History of beneficial effects of antihistaminic treatment. 4. Age between 18 and 75 years. 5. Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed. 6. Voluntarily signed written informed consent.

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Estudio primario

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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria

Año 2015
Autores UCB, Inc.
Registro de estudios EU Clinical Trials Register
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Estudio primario

No clasificado

A phase IV, multicenter, single-arm and open-label study to explore the impact on quality of life of omalizumab (Xolair®) in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment

Año 2015
Autores NOVARTIS PHARMA SAS
Registro de estudios EU Clinical Trials Register
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Estudio primario

No clasificado

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria

Año 2008
Autores UCB Pharma
Registro de estudios clinicaltrials.gov
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To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.

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Estudio primario

No clasificado

A multicenter, randomized, double-blind, placebo-controlled 12-week, parallel-group study with a 6 week follow up period to demonstrate efficacy and safety of subcutaneous Omalizumab in patients with urticaria factitia refractory to standard treatment

Año 2012
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Trade Name: Xolair Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed

INN:

OMALIZUMAB CAS Number: 242138‐07‐4 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 300‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use

CONDITION:

Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] Urticaria factitia ; MedDRA version: 16.0 Level: LLT Classification code 10012499 Term: Dermatographic urticaria System Organ Class: 100000004858

PRIMARY OUTCOME:

Main Objective: To assess the effects of 150 and 300 mg omalizumab on wheal development in UF patients Primary end point(s): Change in critical friction thresholds from baseline to day 70 after treatment with omalizumab compared to placebo. Secondary Objective: To assess the safety of omalizumab in subjects with UF; To assess the effects of omalizumab in UF patients on quality of life, on number of symptom free days, on physician global assessment of disease severity, on patient global assessment of disease severity To assess long‐term effects of omalizumab in UF patients; Timepoint(s) of evaluation of this end point: day 70

SECONDARY OUTCOME:

Secondary end point(s): • To assess the safety of omalizumab in subjects with UF; • To assess the effects of omalizumab in UF patients on quality of life, on number of symptom free days, on physician global assessment of disease severity, on patient global assessment of disease severity; • To assess long‐term effects of omalizumab in UF patients; Timepoint(s) of evaluation of this end point: Day 28, 56, 70, 112

INCLUSION CRITERIA:

Adults (18 years or older) Informed consent signed and dated Able to read, understand and willing to sign the informed consent form and abide with study procedures Diagnosis of UF lasting for at least 6 months Willing, committed and able to return for all clinic visits and complete all study‐related procedures, including willingness to have SC injections administered by a qualified person In females of childbearing potential: Negative pregnancy test; females willing to use highly effective contraception (Pearl‐Index < 1). A woman will be considered not of childbearing potential if she is post‐menopausal for greater than two years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) No participation in other clinical trials 4 weeks before and after participation in this study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Num

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Estudio primario

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A 6-week multicentre, double-blind, randomised, placebo-controlled, parallel-group study to assess the efficacy and safety of rupatadine 10 and 20 mg in the treatment of Chronic Idiopathic Urticaria (CIU): a phase III clinical trial.

Año 2004
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Trade Name: Rupafin 10 mg comprimidos Product Name: Rupatadine Product Code: UR‐12592 Pharmaceutical Form: Tablet INN or Proposed

INN:

Rupatadine CAS Number: 158876‐82‐5 Current Sponsor code: UR‐12592 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Rupafin 10 mg comprimidos Product Name: Rupatadine Product Code: UR‐12592 Pharmaceutical Form: Tablet INN or Proposed

INN:

Rupatadine CAS Number: 158876‐82‐5 Current Sponsor code: UR‐12592 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

CONDITION:

Chronic Idiopathic Urticaria ; MedDRA version: 7 Level: 0 Classification code 10021247

PRIMARY OUTCOME:

Main Objective: To evaluate the efficacy of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four‐week treatment period in comparison with placebo. Primary end point(s): The primary end point will be based on the daily subjective assessment of the severity of each symptom of CIU, as recorded by patients in their diaries.; ; Change in mean pruritus score (MPS) over the 4‐week treatment period. Secondary Objective: To evaluate the efficacy and safety of rupatadine 10 and 20 mg for the treatment of CIU symptoms over six‐week treatment period in comparison with placebo.; ; To evaluate the safety of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four‐week treatment period in comparison with placebo.; ; To assess the patient discomfort by using a VAS.; ; To assess the patient QoL by a specific questionnaire, the DLQI.;

INCLUSION CRITERIA:

Man or woman aged between 12 and 65 Active CIU (score equal or higher than 2 labeled as moderate pruritus) for at least 3 days (not necessarily consecutive days) in the week before inclusion with a total score of active CIU equal or higher than 6 labeled as moderate pruritus for these 3 days Documented history of active CIU (urticaria wheals) with or without an associated angioedema for at least three days per week over the last 6 weeks prior to Screening Visit. 12 lead ECG obtained at screening within acceptable limits Patient who signed the informed consent form. Women of childbearing potential should have a negative pregnancy test. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

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Estudio primario

No clasificado

Angioedema and angioedema management from Asteria I and Asteria II: Phase III studies to evaluate the efficacy and safety of omalizumab in patients with chronic idiopathic/ spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment

Año 2014
Revista Journal of Allergy and Clinical Immunology
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RATIONALE:

Angioedema negatively impacts chronic idiopathic/spontaneous urticariac (CIU/CSU) patients' health-related quality of life. We describe the presence of angioedema and how patients managed it.

METHODS:

Subjects (n=640) were randomized and received placebo or omalizumab 75, 150 or 300 mg at Day 1 and every 4 weeks. Angioedema was assessed via the Urticaria Patient Daily Diary. We summarized the proportion of patients with angioedema, the mean number of days with angioedema per week, the mean proportion of angioedema-free days between Weeks 4-12, and how patients managed angioedema. We report data from Baseline to Week 12.

RESULTS:

During the week prior to randomization, angioedema was a prevalent symptom (41.3% to 46.9%); patients with angioedema reported it, on average, approximately half of the days during that week (3.0 to 3.8 days). DuringWeek 12, fewer patients reported angioedema across all arms (9.7% to 27.5%) and had it, on average, for fewer days during that week (2.3 to 3.3 days); the reduction in patients and days with angioedema was greater in omalizumab-treated patients. The mean proportion of angioedema- free days between Weeks 4-12 was greater in omalizumab-treated patients (90.1% to 95.8%) than in the placebo group (88.7%). Angioedema management generally consisted of low intensity interventions: most patients reported doing nothing or taking medication; some patients reported having called or visited their healthcare provider; none reported visiting the emergency room or being hospitalized.

CONCLUSIONS:

Data from ASTERIA I & II demonstrate that in CIU/ CSU patients who were symptomatic despite H1 antihistamine treatment, omalizumab was efficacious in reducing patient-reported angioedema.

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Estudio primario

No clasificado

An open label, multicenter, extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria patients who completed study CQGE031C2201

Año 2016
Registro de estudios EU Clinical Trials Register
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Estudio primario

No clasificado

Double-blind, parallel, randomized pilot study comparing the efficacy and tolerance of cetiririne 10mg, mequitazine 25 mg and placebo in the treatment of patients suffering from chronic urticaria: comparison of suppressive effects on histamine-induced weals and flares

Año 1998
Revista Drug Dev Res
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