Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00152464
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : January 22, 2019
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dermatitis, Atopic
Interventions Drug: Placebo
Drug: Levocetirizine
Enrollment 514
Recruitment Details The study started to enroll patients in March 2002 and concluded in March 2006.
Pre-assignment Details Participant Flow refers to the Intent-to-treat (ITT) population. 514 subjects were initially randomized, 4 subjects withdrew consent before first study drug intake.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description Placebo was administered as oral drops twice daily. 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Period Title: Overall Study
Started 255 255
Completed 215 219
Not Completed 40 36
Reason Not Completed
Adverse Event             3             6
Lost to Follow-up             8             4
Protocol Violation             3             1
Withdrawal by Subject             21             22
Atopic dermatitis poorly controlled             0             1
Eczema deterioration             0             1
Parent decision             1             1
Investigator decision             1             0
Lack of Efficacy             1             0
Eczema poorly controlled             1             0
Patient relocated             1             0
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Total Title
Hide Arm/Group Description Placebo was administered as oral drops twice daily. 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily. [Not Specified]
Overall Number of Baseline Participants 255 255 510
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Intention-to-Treat (ITT) population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 255 participants 255 participants 510 participants
<=18 years
255
 100.0%
255
 100.0%
510
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 255 participants 255 participants 510 participants
19.42  (3.86) 19.28  (3.94) 19.35  (3.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 255 participants 255 participants 510 participants
Female
91
  35.7%
100
  39.2%
191
  37.5%
Male
164
  64.3%
155
  60.8%
319
  62.5%
1.Primary Outcome
Title Time to Onset of Asthma During the Treatment Period
Hide Description

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.

Time Frame During the treatment period (18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description:
Placebo was administered as oral drops twice daily.
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Overall Number of Participants Analyzed 255 255
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(9.5 to NA)
NA [1] 
(10.3 to NA)
[1]
Median not reached due to insufficient number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (PBO), Levocetirizine (LCTZ)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.991
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.002
Confidence Interval (2-Sided) 95%
0.750 to 1.338
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough
Hide Description 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.
Time Frame During the treatment period (18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description:
Placebo was administered as oral drops twice daily.
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Overall Number of Participants Analyzed 255 255
Mean (Standard Deviation)
Unit of Measure: percentage of days
3.5  (6.26) 2.85  (4.53)
3.Secondary Outcome
Title Percentage of Days With Symptoms of Wheezing
Hide Description The caring person was to note on the diary card each each wheezing event occurring at any time.
Time Frame During the treatment period (18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description:
Placebo was administered as oral drops twice daily.
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Overall Number of Participants Analyzed 255 255
Mean (Standard Deviation)
Unit of Measure: percentage of days
1.31  (3.00) 0.88  (1.87)
4.Secondary Outcome
Title Percentage of Days With Symptoms of Nocturnal Cough
Hide Description 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
Time Frame During the treatment period (18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description:
Placebo was administered as oral drops twice daily.
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Overall Number of Participants Analyzed 255 255
Mean (Standard Deviation)
Unit of Measure: percentage of days
2.72  (5.24) 2.33  (4.30)
5.Secondary Outcome
Title Percentage of Subjects Using Asthma Medication
Hide Description The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists
Time Frame During the treatment period (18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description:
Placebo was administered as oral drops twice daily.
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Overall Number of Participants Analyzed 255 255
Measure Type: Number
Unit of Measure: percentage of participants
Beta 2 Mimetics 33.3 33.3
Cromoglycates 0.8 1.2
Inhaled Corticoids 18.8 15.3
Systemic Corticoids 18.4 12.5
Leukotriene antagonists 2.7 3.5
6.Secondary Outcome
Title Percentage of Days of Use of Asthma Medication
Hide Description The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists
Time Frame During the treatment period (18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
255 subject were included in the Intention-to-treat (ITT) set. Number of participants analyzed is given for each individual category.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description:
Placebo was administered as oral drops twice daily.
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Overall Number of Participants Analyzed 255 255
Mean (Standard Deviation)
Unit of Measure: percentage of days
Beta 2 Mimetics Number Analyzed 249 participants 252 participants
2.36  (9.31) 1.37  (4.47)
Cromoglycates Number Analyzed 255 participants 255 participants
0.03  (0.37) 0.09  (1.24)
Inhaled Corticoids Number Analyzed 252 participants 255 participants
3.60  (12.03) 1.98  (7.49)
Systemic Corticoids Number Analyzed 254 participants 255 participants
0.31  (1.02) 0.13  (0.45)
Leukotriene antagonists Number Analyzed 255 participants 255 participants
0.30  (2.19) 0.34  (3.23)
7.Secondary Outcome
Title Percentage of Subjects Using Medication for Atopic Dermatitis
Hide Description 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
Time Frame During the treatment period (18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description:
Placebo was administered as oral drops twice daily.
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Overall Number of Participants Analyzed 255 255
Measure Type: Number
Unit of Measure: percentage of subjects
Topical corticosteroids 61.6 63.9
Local Steroids Class A, NSAI creams, tar 31.4 33.3
Local Steroids Class B 28.6 27.1
Local Steroids Class C 33.7 37.3
Topical tacrolimus 0.8 1.2
Topical pimecrolimus 2.4 5.5
Systemic H1 anti-histamines 22.0 19.6
Local antibiotics or antiseptics 12.9 11.0
8.Secondary Outcome
Title Percentage of Days of Use of Medication for Atopic Dermatitis
Hide Description 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
Time Frame During the treatment period (18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
255 subject were included in the Intention-to-treat (ITT) set. Number of participants analyzed is given for each individual category.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description:
Placebo was administered as oral drops twice daily.
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Overall Number of Participants Analyzed 255 255
Mean (Standard Deviation)
Unit of Measure: percentage of days
Topical corticosteroids Number Analyzed 223 participants 231 participants
32.42  (42.96) 31.84  (42.70)
LSC A, NSAI creams, tar Number Analyzed 238 participants 242 participants
15.40  (33.69) 18.64  (37.30)
LSC B Number Analyzed 240 participants 245 participants
14.23  (32.19) 12.30  (30.49)
LSC C Number Analyzed 243 participants 247 participants
9.82  (24.98) 8.27  (22.16)
Topical tacrolimus Number Analyzed 255 participants 254 participants
0.36  (5.41) 0.02  (0.21)
Topical pimecrolimus Number Analyzed 255 participants 254 participants
0.52  (5.62) 0.31  (2.31)
Systemic H1 a-h Number Analyzed 247 participants 252 participants
3.80  (14.28) 1.95  (8.84)
Local ABs or antiseptics Number Analyzed 252 participants 253 participants
2.99  (15.00) 2.63  (15.37)
9.Secondary Outcome
Title Percentage of Subjects With Urticaria
Hide Description 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.
Time Frame During the treatment period (18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description:
Placebo was administered as oral drops twice daily.
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Overall Number of Participants Analyzed 255 255
Measure Type: Number
Unit of Measure: percentage of participants
41.6 27.5
10.Secondary Outcome
Title Number of Episodes of Urticaria Per Subject
Hide Description 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.
Time Frame During the treatment period (18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description:
Placebo was administered as oral drops twice daily.
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Overall Number of Participants Analyzed 255 255
Mean (Standard Deviation)
Unit of Measure: Number of episodes
1.71  (4.05) 0.71  (1.83)
Time Frame Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Event Reporting Description Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
 
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ)
Hide Arm/Group Description Placebo was administered as oral drops twice daily. 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
All-Cause Mortality
Placebo (PBO) Levocetirizine (LCTZ)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/255 (0.00%)   0/255 (0.00%) 
Hide Serious Adverse Events
Placebo (PBO) Levocetirizine (LCTZ)
Affected / at Risk (%) Affected / at Risk (%)
Total   37/255 (14.51%)   31/255 (12.16%) 
Congenital, familial and genetic disorders     
Patent ductus arteriosus * 1  0/255 (0.00%)  1/255 (0.39%) 
Gastrointestinal disorders     
Constipation * 2  1/255 (0.39%)  0/255 (0.00%) 
Diarrhoea * 2  1/255 (0.39%)  0/255 (0.00%) 
Dyspepsia * 2  1/255 (0.39%)  0/255 (0.00%) 
Food poisoning * 2  0/255 (0.00%)  1/255 (0.39%) 
Rectal polyp * 2  1/255 (0.39%)  0/255 (0.00%) 
Vomiting * 2  0/255 (0.00%)  1/255 (0.39%) 
Immune system disorders     
Food allergy * 2  1/255 (0.39%)  0/255 (0.00%) 
Hypersensitivity * 2  1/255 (0.39%)  0/255 (0.00%) 
Infections and infestations     
Acute tonsillitis * 2  0/255 (0.00%)  1/255 (0.39%) 
Bronchitis acute * 2  0/255 (0.00%)  1/255 (0.39%) 
Bronchitis chronic * 2  3/255 (1.18%)  0/255 (0.00%) 
Bronchopneumonia * 2  1/255 (0.39%)  4/255 (1.57%) 
Eczema infected * 2  1/255 (0.39%)  0/255 (0.00%) 
Gastroenteritis * 2  5/255 (1.96%)  2/255 (0.78%) 
Gastroenteritis rotavirus * 2  1/255 (0.39%)  0/255 (0.00%) 
Haemophilus infection * 2  1/255 (0.39%)  0/255 (0.00%) 
Lower respiratory tract infection * 2  0/255 (0.00%)  1/255 (0.39%) 
Pneumonia * 2  0/255 (0.00%)  2/255 (0.78%) 
Pyelonephritis * 2  0/255 (0.00%)  1/255 (0.39%) 
Pyelonephritis acute * 2  1/255 (0.39%)  0/255 (0.00%) 
Skin infection * 2  0/255 (0.00%)  1/255 (0.39%) 
Subcutaneous abscess * 2  1/255 (0.39%)  0/255 (0.00%) 
Tonsillitis * 2  0/255 (0.00%)  1/255 (0.39%) 
Upper respiratory tract infection * 2  0/255 (0.00%)  1/255 (0.39%) 
Viral infection * 2  1/255 (0.39%)  0/255 (0.00%) 
Viral upper respiratory tract infection * 2  0/255 (0.00%)  1/255 (0.39%) 
Bronchitis * 2  0/255 (0.00%)  1/255 (0.39%) 
Injury, poisoning and procedural complications     
Concussion * 2  0/255 (0.00%)  1/255 (0.39%) 
Head injury * 2  0/255 (0.00%)  1/255 (0.39%) 
Investigations     
Hepatic enzyme increased * 2  1/255 (0.39%)  0/255 (0.00%) 
Weight increased * 2  0/255 (0.00%)  1/255 (0.39%) 
Metabolism and nutrition disorders     
Dehydration * 2  0/255 (0.00%)  1/255 (0.39%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute lymphocytic leukaemia * 2  0/255 (0.00%)  1/255 (0.39%) 
Nervous system disorders     
Convulsion * 2  0/255 (0.00%)  1/255 (0.39%) 
Febrile convulsion * 2  0/255 (0.00%)  4/255 (1.57%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 2  1/255 (0.39%)  0/255 (0.00%) 
Cough * 2  2/255 (0.78%)  4/255 (1.57%) 
Dyspnoea * 2  1/255 (0.39%)  1/255 (0.39%) 
Wheezing * 2  19/255 (7.45%)  12/255 (4.71%) 
Skin and subcutaneous tissue disorders     
Angioneurotic oedema * 2  1/255 (0.39%)  1/255 (0.39%) 
Dermatitis atopic * 2  6/255 (2.35%)  3/255 (1.18%) 
Urticaria * 2  3/255 (1.18%)  1/255 (0.39%) 
1
Term from vocabulary, MedDRA8.0
2
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (PBO) Levocetirizine (LCTZ)
Affected / at Risk (%) Affected / at Risk (%)
Total   240/255 (94.12%)   239/255 (93.73%) 
Eye disorders     
Conjunctivitis * 1  41/255 (16.08%)  49/255 (19.22%) 
Gastrointestinal disorders     
Constipation * 1  8/255 (3.14%)  14/255 (5.49%) 
Diarrhoea * 1  41/255 (16.08%)  48/255 (18.82%) 
Teething * 1  21/255 (8.24%)  22/255 (8.63%) 
Vomiting * 1  29/255 (11.37%)  31/255 (12.16%) 
General disorders     
Pyrexia * 1  71/255 (27.84%)  85/255 (33.33%) 
Immune system disorders     
Seasonal allergy * 1  13/255 (5.10%)  6/255 (2.35%) 
Infections and infestations     
Bronchitis * 1  52/255 (20.39%)  44/255 (17.25%) 
Bronchitis acute * 1  13/255 (5.10%)  12/255 (4.71%) 
Ear infection * 1  39/255 (15.29%)  38/255 (14.90%) 
Gastroenteritis * 1  55/255 (21.57%)  57/255 (22.35%) 
Influenza * 1  18/255 (7.06%)  25/255 (9.80%) 
Laryngitis * 1  9/255 (3.53%)  19/255 (7.45%) 
Nasopharyngitis * 1  74/255 (29.02%)  79/255 (30.98%) 
Otitis media * 1  40/255 (15.69%)  36/255 (14.12%) 
Pharyngitis * 1  53/255 (20.78%)  58/255 (22.75%) 
Respiratory tract infection * 1  18/255 (7.06%)  15/255 (5.88%) 
Rhinitis * 1  71/255 (27.84%)  73/255 (28.63%) 
Tonsillitis * 1  28/255 (10.98%)  21/255 (8.24%) 
Upper respiratory tract infection * 1  126/255 (49.41%)  131/255 (51.37%) 
Varicella * 1  34/255 (13.33%)  30/255 (11.76%) 
Viral infection * 1  24/255 (9.41%)  25/255 (9.80%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  67/255 (26.27%)  57/255 (22.35%) 
Rhinitis allergic * 1  19/255 (7.45%)  24/255 (9.41%) 
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT00152464    
Other Study ID Numbers: A00309
First Submitted: September 8, 2005
First Posted: September 9, 2005
Results First Submitted: October 10, 2017
Results First Posted: January 22, 2019
Last Update Posted: January 22, 2019