AsthmaPhase 3NCT00160563
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)
A Phase 3 study testing LEVOCETIRIZINE in people with Asthma, run by UCB Pharma at 51 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 42 months
- Conditions the study is for
- Asthma
- What is being tested?
- LEVOCETIRIZINE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 51 sitesin 10 countries
- Study dates
- Jun 2004to Mar 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 42 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
51 sites in 10 countries.
51 sites in 10 countries
South Africa9 sites
Study site
Bellville
Study site
Clarement
Study site
Durban
Study site
Mowbray
Study site
Pietermaritzburg
Study site
Sydenham
Study site
West Honeydew
Study site
Westville
Study site
Wynberg
Germany8 sites
Study site
Bayreuth
Study site
Berlin
Study site
Bielefeld
Study site
Bochum
Study site
Cologne
Study site
Erlangen
Study site
München
Study site
Wesel
Italy8 sites
Study site
Ancona
Study site
Bari
Study site
Bologna
Study site
Messina
Study site
Milan
Study site
Naples
Study site
Pavia
Study site
Roma
Poland8 sites
Study site
Bialystock
Study site
Gdansk
Study site
Karpacz
Study site
Lodz
Study site
Lublin
Study site
Rabka-Zdrój
Study site
Warsaw
Study site
Wroclaw
Czechia6 sites
Study site
Brno
Study site
Hradec Králové
Study site
Olomouc
Study site
Ostrava
Study site
Plezen-Lochotin
Study site
Prague
France4 sites
Study site
Martigues
Study site
Saint-Etienne
Study site
Tarbes
Study site
Toulouse
United Kingdom3 sites
Study site
Dorchester
Study site
Enfield
Study site
Southampton
Australia2 sites
Study site
North Adelaide
Study site
Parkville (North Melbourne)
About this study
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.
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.
- Conditions
- Asthma
- Being tested
- LEVOCETIRIZINE, Placebo
- Keywords
- Pediatry, EPAAC, atopic Children, prevention of asthma, Levocetirizine, Xyzal
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEVOCETIRIZINEDrug
Also called Xyzal®
5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
PlaceboOther
Oral drops, bid for 18 months
| Study group | Role | What they receive |
|---|---|---|
| LCTZ-LCTZ | Experimental | Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ) Receives: Drug: LEVOCETIRIZINE |
| LCTZ-PLC | Placebo comparator | Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC) Receives: Other: Placebo |
| PLC-PLC | Placebo comparator | Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Onset of Asthma
Measured: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
Secondary outcomes (1)
Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.
Measured: 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionMar 2006
- Study completionMar 2006
Why it stopped: The predecessor study A00309 (NCT00152464) did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabelle Campine, MD, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160563
- Sponsor's protocol ID
- A00384
- Status last verified
- May 2011
- First submitted
- 8 Sep 2005
- Last updated
- 3 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00160563
- Acronym / sponsor ID
- A00384
- Conditions
- Asthma
- Keywords
- Pediatry, EPAAC, atopic Children, prevention of asthma, Levocetirizine, Xyzal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The predecessor study A00309 (NCT00152464) did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups.
- Enrolment
- 207 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 4 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LCTZ-LCTZ | Experimental | Drug: LEVOCETIRIZINELevocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ) |
| LCTZ-PLC | Placebo comparator | Other: PlaceboPlacebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC) |
| PLC-PLC | Placebo comparator | Other: PlaceboPlacebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC) |
Who may qualify
- Ages
- 30 to 42 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEVOCETIRIZINEAlso: Xyzal®5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months | Drug | LCTZ-LCTZ |
| PlaceboOral drops, bid for 18 months | Other | LCTZ-PLC, PLC-PLC |
Primary outcome
Time to Onset of Asthma
Time frame: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
1 secondary outcome
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.)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- For FDA Safety Alerts and Recalls refer toLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Campine, MD study director
UCB Pharma
51 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LEVOCETIRIZINE in people with Asthma, run by UCB Pharma at 51 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in South Africa, Germany, Italy, Poland, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Onset of Asthma (time frame: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.