Prevention of Asthma With Levocetirizine (36 Month Treatment) in Young Children Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and House Dust Mite and Having Completed the Previous EPAAC Trial (NCT00152464)
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| ClinicalTrials.gov Identifier: NCT00160563 |
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Recruitment Status :
Terminated
(The predecessor study A00309 (NCT00152464) did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups.)
First Posted : September 12, 2005
Results First Posted : August 4, 2009
Last Update Posted : March 3, 2015
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Drug: LEVOCETIRIZINE Other: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 207 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Prolongation of the EPAAC™ Trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). A Multi-country, Double Blind, Placebo (PLC) Controlled, Follow-up Trial With 3 Parallel Groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluation of the Long Term Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for an Additional 18 Months Period in Preventing the Onset of Asthma in Children Coming From the EPAAC Trial. |
| Study Start Date : | June 2004 |
| Actual Primary Completion Date : | March 2006 |
| Actual Study Completion Date : | March 2006 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Atopic dermatitis
MedlinePlus related topics:
Asthma
| Arm | Intervention/treatment |
|---|---|
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Experimental: LCTZ-LCTZ
Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ)
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Drug: LEVOCETIRIZINE
5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
Other Name: Xyzal® |
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Placebo Comparator: LCTZ-PLC
Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC)
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Other: Placebo
Oral drops, bid for 18 months |
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Placebo Comparator: PLC-PLC
Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)
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Other: Placebo
Oral drops, bid for 18 months |
Primary Outcome Measures :
- Time to Onset of Asthma [ Time Frame: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.) ]
Secondary Outcome Measures :
- Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months. [ Time Frame: 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 30 Months to 42 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Inclusion criteria which must be verified at the end of first 18-months treatment (Visit 9)
- Having completed the previous 18-month treatment period of the EPAAC trial - NCT00152464
Exclusion Criteria:
- None
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160563
Locations
Show 52 study locations
Sponsors and Collaborators
UCB Pharma
Investigators
| Study Director: | Isabelle Campine, MD | UCB Pharma |
Additional Information:
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00160563 |
| Other Study ID Numbers: |
A00384 |
| First Posted: | September 12, 2005 Key Record Dates |
| Results First Posted: | August 4, 2009 |
| Last Update Posted: | March 3, 2015 |
| Last Verified: | May 2011 |
Keywords provided by UCB Pharma:
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Pediatry EPAAC atopic Children |
prevention of asthma Levocetirizine Xyzal |
Additional relevant MeSH terms:
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Levocetirizine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |