Dermatitis, AtopicPhase 3NCT00152464
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)
A Phase 3 study testing Levocetirizine in people with Dermatitis, Atopic, run by UCB Pharma SA.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 24 months
- Conditions the study is for
- Dermatitis, Atopic
- 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
- 514 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2002to 15 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 12 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inclusion criteria which must be verified during screening visit (V1):
- Children of either sex aged between 12 and 24 months
- Subjects suffering from symptoms of Atopic Dermatitis (AD) lasting cumulatively for at least 2 months since birth
- Modified Severity Scoring of Atopic Dermatitis (SCORAD) Index >= 10
- Subjects whose biological mother or father, or one sibling has a well-documented history of atopy (AD, allergic rhinitis or asthma)
- Inclusion criteria which must be verified during randomization (V2):
- Results of the Radio-allergosorbant (RAST) test for grass pollen (GP) and house dust mite (HDM) are available and Immunoglobulin E (IgE) level against GP >= 0.35 kUA/l and/or IgE level against HDM ≥ 0.35 kUA/l
- Safety laboratory results are within the normal range of the central laboratory or considered as not clinically significant or study disease related by the Investigator
Who cannot join
- 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
Show all 21Show fewer
- 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:
- Intranasal or systemic antihistamines: 3 days,
- Intranasal or systemic decongestants: 3 days,
- Loratadine, Desloratadine: 10 days,
- Chromones: 2 weeks,
- Oral corticosteroids: 1 month,
- Chronic use (i.e. cumulatively up to 2 weeks within the last 3 months) of inhaled/intranasal corticosteroids: 1 month,
- Ketotifen: 1 month,
- Astemizole: 6 weeks
- 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
About this study
Official title: The Early Prevention of Asthma in Atopic Children (EPAAC™) Study. A Multi-country, Double Blind, Placebo (PLC) Controlled, Randomized, Parallel Group Trial: Evaluation of the Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for 18 Months in Preventing the Onset of Asthma in 12 to 24 Months Old Children Who Suffer From Atopic Dermatitis and Are Sensitized to Grass Pollen and / or House Dust Mite Allergens.
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.
- Conditions
- Dermatitis, Atopic
- Being tested
- Placebo, Levocetirizine
- Keywords
- EPAAC, Atopic children, Asthma, XYZAL, Levocetirizine
- Medical subject headings
- Dermatitis, Atopic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Pharmaceutical form: Oral drops Route of administration: Oral use
LevocetirizineDrug
Also called Xyzal
Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| Levocetirizine (LCTZ) | Experimental | 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily. Receives: Drug: Levocetirizine |
| Placebo (PBO) | Placebo comparator | Placebo was administered as oral drops twice daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the treatment period (18 months)
Secondary outcomes (9)
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.
Measured: During the treatment period (18 months)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: During the treatment period (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study start20 Mar 2002
- Primary completion15 Mar 2006
- Study completion15 Mar 2006
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 Dermatitis, AtopicStudies 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
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152464
- Sponsor's protocol ID
- A00309
- Status last verified
- Aug 2018
- First submitted
- 8 Sep 2005
- Last updated
- 22 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Prevention of Asthma in Atopic Children (EPAAC™) Study. A Multi-country, Double Blind, Placebo (PLC) Controlled, Randomized, Parallel Group Trial: Evaluation of the Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for 18 Months in Preventing the Onset of Asthma in 12 to 24 Months Old Children Who Suffer From Atopic Dermatitis and Are Sensitized to Grass Pollen and / or House Dust Mite Allergens.
- ClinicalTrials.gov ID
- NCT00152464
- Acronym / sponsor ID
- A00309
- Conditions
- Dermatitis, Atopic
- Keywords
- EPAAC, Atopic children, Asthma, XYZAL, Levocetirizine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- UCB Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2002 (actual)
- Primary completion
- 15 Mar 2006 (actual)
- Study completion
- 15 Mar 2006 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Posted 22 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levocetirizine (LCTZ) | Experimental | Drug: Levocetirizine0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily. |
| Placebo (PBO) | Placebo comparator | Drug: PlaceboPlacebo was administered as oral drops twice daily. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children of either sex aged between 12 and 24 months
- Subjects suffering from symptoms of Atopic Dermatitis (AD) lasting cumulatively for at least 2 months since birth
- Modified Severity Scoring of Atopic Dermatitis (SCORAD) Index >= 10
- Subjects whose biological mother or father, or one sibling has a well-documented history of atopy (AD, allergic rhinitis or asthma)
- Results of the Radio-allergosorbant (RAST) test for grass pollen (GP) and house dust mite (HDM) are available and Immunoglobulin E (IgE) level against GP >= 0.35 kUA/l and/or IgE level against HDM ≥ 0.35 kUA/l
Key exclusion criteria (21 listed)
- 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
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 |
|---|---|---|
| PlaceboPharmaceutical form: Oral drops Route of administration: Oral use | Drug | Placebo (PBO) |
| LevocetirizineAlso: XyzalPharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use | Drug | Levocetirizine (LCTZ) |
Primary outcome
Time to Onset of Asthma During the Treatment Period
Time frame: During the treatment period (18 months)
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.
9 secondary outcomes
Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough
Time frame: During the treatment period (18 months)
Percentage of Days With Symptoms of Wheezing
Time frame: During the treatment period (18 months)
Percentage of Days With Symptoms of Nocturnal Cough
Time frame: During the treatment period (18 months)
Percentage of Subjects Using Asthma Medication
Time frame: During the treatment period (18 months)
Percentage of Days of Use of Asthma Medication
Time frame: During the treatment period (18 months)
Percentage of Subjects Using Medication for Atopic Dermatitis
Time frame: During the treatment period (18 months)
Percentage of Days of Use of Medication for Atopic Dermatitis
Time frame: During the treatment period (18 months)
Percentage of Subjects With Urticaria
Time frame: During the treatment period (18 months)
Number of Episodes of Urticaria Per Subject
Time frame: During the treatment period (18 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levocetirizine in people with Dermatitis, Atopic, run by UCB Pharma SA.
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 8 inclusion and 21 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: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 22 Jan 2019). 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 During the Treatment Period (time frame: During the treatment period (18 months)). 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 22 Jan 2019.