Not provided
Not provided
Not provided
Not provided
Not provided
The predecessor study A00309 (NCT00152464) did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children).
36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCTZ-LCTZ | Experimental | Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ) |
|
| LCTZ-PLC | Placebo Comparator | Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC) |
|
| PLC-PLC | Placebo Comparator | Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEVOCETIRIZINE | Drug | 5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of Asthma | 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months. | 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.) |
Not provided
Inclusion Criteria:
Inclusion criteria which must be verified at the end of first 18-months treatment (Visit 9)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Isabelle Campine, MD | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Adelaide | Australia | |||||
Not provided
| Label | URL |
|---|---|
| For FDA Safety Alerts and Recalls refer to | View source |
Not provided
In total, 207 subjects from study A00309 - NCT00152464 entered this prolongation study. Participants Flow and Baseline Characteristics sections show patients as randomized. One patient (016/1709) received LCTZ instead of PLC in the PLC-PLC arm erroneously and is described separately in the Adverse Event section.
This study is a 18-month prolongation study to study A00309 (EPAAC study - NCT00152464) and was prematurely terminated due to the fact that the primary endpoint in study A00309 - NCT00152464 was not met.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LCTZ-LCTZ | Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ) |
| FG001 | LCTZ-PLC | Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Oral drops, bid for 18 months |
|
| Parkville (North Melbourne) |
| Australia |
| Brussels | Belgium |
| Brno | Czechia |
| Hradec Králové | Czechia |
| Olomouc | Czechia |
| Ostrava | Czechia |
| Plezen-Lochotin | Czechia |
| Prague | Czechia |
| Martigues | France |
| Saint-Etienne | France |
| Tarbes | France |
| Toulouse | France |
| Bayreuth | Germany |
| Berlin | Germany |
| Bielefeld | Germany |
| Bochum | Germany |
| Cologne | Germany |
| Erlangen | Germany |
| München | Germany |
| Wesel | Germany |
| Ancona | Italy |
| Bari | Italy |
| Bologna | Italy |
| Messina | Italy |
| Milan | Italy |
| Naples | Italy |
| Pavia | Italy |
| Roma | Italy |
| Bialystock | Poland |
| Gdansk | Poland |
| Karpacz | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Rabka-Zdrój | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Bellville | South Africa |
| Clarement | South Africa |
| Durban | South Africa |
| Mowbray | South Africa |
| Pietermaritzburg | South Africa |
| Sydenham | South Africa |
| West Honeydew | South Africa |
| Westville | South Africa |
| Wynberg | South Africa |
| Barcelona | Spain |
| Espluques de Llobreqat | Spain |
| Dorchester | United Kingdom |
| Enfield | United Kingdom |
| Southampton | United Kingdom |
| FG002 | PLC-PLC | Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LCTZ-LCTZ | Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ) |
| BG001 | LCTZ-PLC | Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC) |
| BG002 | PLC-PLC | Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Analysis was not performed due to premature discontinuation of the study. | Posted | 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.) |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months. | Analysis was not performed due to premature discontinuation of the study. | Posted | 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.) |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LCTZ-LCTZ | Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ) | 5 | 59 | 48 | 59 | ||
| EG001 | LCTZ-PLC | Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC) | 3 | 47 | 36 | 47 | ||
| EG002 | PLC-PLC | Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC) | 3 | 100 | 71 | 100 | ||
| EG003 | PLC-LCTZ | Levocetirizine after having been randomized to Placebo in the preceding A00309 trial (PLC-LCTZ) erroneously (Patient 016/1709) | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 8.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 8.0 | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Bronchitis acute | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Scarlet fever | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1 877 822 9493 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C472067 | levocetirizine |
Not provided
Not provided
Not provided
| Male |
|
| Czech Republic |
|
| Poland |
|
| Spain |
|
| Belgium |
|
| Australia |
|
| South Africa |
|
| Germany |
|
| Italy |
|
| United Kingdom |
|