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The Early Prevention of Asthma in Atopic Children (EPAAC™). 24 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24 months old children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levocetirizine (LCTZ) | Experimental | 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily. |
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| Placebo (PBO) | Placebo Comparator | Placebo was administered as oral drops twice daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Pharmaceutical form: Oral drops Route of administration: Oral use |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of Asthma During the Treatment Period | The time to onset of asthma was defined as the period elapsed between the randomization visit (V2) and the date of onset of asthma. Instead of the median the first Quartile is reported since the median (50%) was not reached. | During the treatment period (18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough | The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am and each wheezing event occurring at any time together with the treatment for these symptoms. | During the treatment period (18 months) |
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Inclusion Criteria:
Inclusion criteria which must be verified during screening visit (V1):
Inclusion criteria which must be verified during randomization (V2):
Exclusion Criteria:
Exclusion criteria to verify at screening visit (V1):
Are to be excluded from the participation in the study, those children who
Have height or weight below the 5th percentile
Have experienced at least one episode of wheezing when aged 6 months or over
Have suffered at age 6 months or over, from at least one nocturnal cough episode consisting of 3 (or more) consecutive nights resulting in sleep disturbances in a clinical setting where asthma is likely and other conditions have been excluded
Have chronic pulmonary diseases of any type, such as, but not limited to, cystic fibrosis, or any cranio-facial abnormality, e.g., cleft palate
Have a personal history of sleep apnea or who have siblings with a history of sleep apnea
Are treated with any immunomodulator medication such as, e.g., cyclosporin, cyclophosphamide or FK 506 (Tacrolimus)
Have received or are receiving allergen - specific immunotherapy
Suffer from concomitant dermatological disease/condition other than atopic dermatitis, that might interfere with the evaluation of the clinical response for atopic dermatitis
Have an insufficient wash-out period for the following medications:
Have been treated with any antihistamine, including ketotifen, with daily intake for more than 2 consecutive months in the last 6 months before screening
Subject Exclusion criteria to verify at randomization visit (V2):
• Intake of any prohibited medication listed above during the selection period
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Intent-to-treat (ITT) population. 514 subjects were initially randomized, 4 subjects withdrew consent before first study drug intake.
The study started to enroll patients in March 2002 and concluded in March 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (PBO) | Placebo was administered as oral drops twice daily. |
| FG001 | Levocetirizine (LCTZ) | 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Levocetirizine |
| Drug |
Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use |
|
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| Percentage of Days With Symptoms of Wheezing |
The caring person was to note on the diary card each each wheezing event occurring at any time. |
| During the treatment period (18 months) |
| Percentage of Days With Symptoms of Nocturnal Cough | The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am | During the treatment period (18 months) |
| Percentage of Subjects Using Asthma Medication | The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists | During the treatment period (18 months) |
| Percentage of Days of Use of Asthma Medication | The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists | During the treatment period (18 months) |
| Percentage of Subjects Using Medication for Atopic Dermatitis | The following medications for Atopic Dermatitis were taken into consideration: Topical corticosteroids/ Local Steroids Class A, non-steroidal anti-inflammatory (NSAI) creams, tar/ Local Steroids Class B/ Local Steroids Class C/ Topical tacrolimus/ Topical pimecrolimus/ Systemic H1 anti-histamines/ Local antibiotics or antiseptics | During the treatment period (18 months) |
| Percentage of Days of Use of Medication for Atopic Dermatitis | The following medications for Atopic Dermatitis were taken into consideration: Emollients, local antihistamines; Local steroids class (LSC) A, non-steroidal anti-inflammatory (NSAI) creams, tar; Local steroids class B; Local steroids class C; Local antibiotics or antiseptics; Oral H1 anti-histamines (a-h); Local antibiotics (ABs) or antiseptics | During the treatment period (18 months) |
| Percentage of Subjects With Urticaria | Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger. | During the treatment period (18 months) |
| Number of Episodes of Urticaria Per Subject | Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger. | During the treatment period (18 months) |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Intention-to-Treat (ITT) population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (PBO) | Placebo was administered as oral drops twice daily. |
| BG001 | Levocetirizine (LCTZ) | 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily. |
| BG002 | Total Title |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Onset of Asthma During the Treatment Period | The time to onset of asthma was defined as the period elapsed between the randomization visit (V2) and the date of onset of asthma. Instead of the median the first Quartile is reported since the median (50%) was not reached. | Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | During the treatment period (18 months) |
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| Secondary | Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough | The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am and each wheezing event occurring at any time together with the treatment for these symptoms. | Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication. | Posted | Mean | Standard Deviation | percentage of days | During the treatment period (18 months) |
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| Secondary | Percentage of Days With Symptoms of Wheezing | The caring person was to note on the diary card each each wheezing event occurring at any time. | Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication. | Posted | Mean | Standard Deviation | percentage of days | During the treatment period (18 months) |
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| Secondary | Percentage of Days With Symptoms of Nocturnal Cough | The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am | Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication. | Posted | Mean | Standard Deviation | percentage of days | During the treatment period (18 months) |
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| Secondary | Percentage of Subjects Using Asthma Medication | The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists | Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication. | Posted | Number | percentage of participants | During the treatment period (18 months) |
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| Secondary | Percentage of Days of Use of Asthma Medication | The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists | 255 subject were included in the Intention-to-treat (ITT) set. Number of participants analyzed is given for each individual category. | Posted | Mean | Standard Deviation | percentage of days | During the treatment period (18 months) |
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| Secondary | Percentage of Subjects Using Medication for Atopic Dermatitis | The following medications for Atopic Dermatitis were taken into consideration: Topical corticosteroids/ Local Steroids Class A, non-steroidal anti-inflammatory (NSAI) creams, tar/ Local Steroids Class B/ Local Steroids Class C/ Topical tacrolimus/ Topical pimecrolimus/ Systemic H1 anti-histamines/ Local antibiotics or antiseptics | Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication. | Posted | Number | percentage of subjects | During the treatment period (18 months) |
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| Secondary | Percentage of Days of Use of Medication for Atopic Dermatitis | The following medications for Atopic Dermatitis were taken into consideration: Emollients, local antihistamines; Local steroids class (LSC) A, non-steroidal anti-inflammatory (NSAI) creams, tar; Local steroids class B; Local steroids class C; Local antibiotics or antiseptics; Oral H1 anti-histamines (a-h); Local antibiotics (ABs) or antiseptics | 255 subject were included in the Intention-to-treat (ITT) set. Number of participants analyzed is given for each individual category. | Posted | Mean | Standard Deviation | percentage of days | During the treatment period (18 months) |
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| Secondary | Percentage of Subjects With Urticaria | Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger. | Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication. | Posted | Number | percentage of participants | During the treatment period (18 months) |
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| Secondary | Number of Episodes of Urticaria Per Subject | Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger. | Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication. | Posted | Mean | Standard Deviation | Number of episodes | During the treatment period (18 months) |
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Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (PBO) | Placebo was administered as oral drops twice daily. | 0 | 255 | 37 | 255 | 240 | 255 |
| EG001 | Levocetirizine (LCTZ) | 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily. | 0 | 255 | 31 | 255 | 239 | 255 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA8.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Rectal polyp | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Food allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
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| Acute tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Bronchitis acute | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Bronchitis chronic | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Eczema infected | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Gastroenteritis rotavirus | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Febrile convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Angioneurotic oedema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Teething | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Bronchitis acute | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Varicella | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C472067 | levocetirizine |
Not provided
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| >=65 years |
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| Male |
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