AsthmaPhase 2GPACNCT00346398
Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study
A Phase 2 study testing Oral mucosal immunoprophylaxis (OMIP) in people with Asthma and Allergic Sensitization, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease. Read more about this study
- Who is it for?
- Ages 12 to 30 months
- Conditions the study is for
- Asthma, Allergic Sensitization
- What is being tested?
- Oral mucosal immunoprophylaxis (OMIP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2006to Jul 2011
- Phase
- Phase 2
- 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 30 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with eczema (atopic dermatitis)
- Family history of eczema, allergic rhinitis, or asthma
- Allergy to one or more of the following: egg white, cow's milk, peanut, or soybean
- Weigh at least 9.5 kg (20.9 lbs)
- Parent or guardian willing to provide informed consent
Who cannot join
- Allergy to house dust mite, cat, or timothy grass
- Born prematurely (before 36th week's gestation)
- Previous diagnosis of asthma OR have had 3 or more distinct episodes of wheeze during the first year of life
- Chronic pulmonary disease
- Chronic disease requiring therapy
- Past or current treatment with systemic immunomodulator medication
Show all 10Show fewer
- Past or current treatment with allergen-specific immunotherapy
- Received 10 or more days of systemic steroids in the 3 months prior to study entry
- Orofacial abnormalities that are likely to interfere with the subject's ability to take study treatment
- Participated in another clinical study within the 3 months prior to study entry
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
Royal Children's Hospital
Melbourne, Victoria, 3052
Telethon Institute for Child Health Research
Perth, Western Australia, 6008
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)
The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.
Read the detailed description
Researchers suspect that allergies to common inhaled allergens (such as house dust mite, cat dander, and grass pollens) are a major cause of childhood asthma. Recent evidence suggests that if allergies to inhaled allergens are prevented, this can cause changes in the immune system that may inhibit the development of asthma. Although strategies to prevent allergies generally focus on avoiding the allergen, complete avoidance of the common allergens linked to asthma would require extreme measures and is impractical.
Oral mucosal immunoprophylaxis (OMIP) therapy is an allergy treatment that can induce long-lasting immune tolerance in people already suffering from allergies. By exposing the patient to small, repeated, but increasing doses of the problem allergen over a long period of time, the patient's immune system is eventually desensitized to that particular allergen. OMIP therapy has been shown to be safe in children as young as 2 years old. This study will evaluate if OMIP therapy against common inhaled allergens is safe and effective in preventing the development of asthma in children at high risk for developing the disease. Children enrolled in this study have been diagnosed with eczema or food allergies and have a family history of eczema, allergic rhinitis, or asthma.
There are two groups in this study. The experimental arm participants will receive OMIP therapy (a mixture of house dust mite, cat, and timothy grass allergens) as daily oral drops under the tongue for 1 year; Placebo arm participants will receive an allergen free placebo solution. Participants will be followed for an additional 3 years to see whether they develop allergies or asthma and to determine how OMIP affects their immune system's response to allergens. There will be 5 study visits in the first year and 6 visits over the next 3 years. At all visits, participants will be assessed for allergy/asthma symptoms, will be asked to complete questionnaires, and may be asked to provide blood or saliva samples.
- Conditions
- Asthma, Allergic Sensitization
- Being tested
- Oral mucosal immunoprophylaxis (OMIP), Placebo
- Keywords
- asthma, allergen, allergic disease, allergen immunotherapy, allergic sensitization, atopic dermatitis, eczema, food allergy, oral mucosal immunoprophylaxis (OMIP)
- Medical subject headings
- Asthma, Dermatitis, Atopic, Eczema, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral mucosal immunoprophylaxis (OMIP)Biological
Also called Allergen immunotherapy
OMIP consists of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL.
PlaceboBiological
The placebo consists of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL.
| Study group | Role | What they receive |
|---|---|---|
| Oral mucosal immunoprophylaxis (OMIP) | Experimental | Participants are administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. Receives: Biological: Oral mucosal immunoprophylaxis (OMIP) |
| Placebo | Placebo comparator | Participants are administered, via the same route as the experimental group, an oral placebo solution daily for 12 months. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion
Allergic sensitization is defined as a positive serum allergen specific Immunoglobulin E (IgE) CAP test[1] or a positive allergy skin prick test[2]. Not experiencing allergic sensitization is the better outcome for this measure.
- A positive serum allergen specific IgE CAP (ImmunoCAP) test result is defined by a result >= 0.35 kU/L. Higher scores indicate greater allergic sensitization.
- A positive skin prick test is defined as a wheal diameter that is 3 mm larger than that produced by a negative control. Higher wheal sizes indicate greater allergic reaction or sensitization.
Measured: Three years (36 months) after Treatment Completion
Secondary outcomes (2)
Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion
Participants who currently have asthma three years after end of treatment. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze. Current asthma is defined as a diagnosis of asthma and at least one episode of wheeze lasting 3 or more consecutive days in the past 12 months.
Measured: Three years (36 months) after Treatment Completion
Time to First Onset of Asthma
Time to first onset of asthma is the time from the day a participant is randomized and initiates study treatment to the diagnosis of the first of three episodes of asthma. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze.
Measured: From Treatment Initiation to Month 36 Status Post Treatment Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2011
- Study completionJul 2011
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Responsible party
- Sponsor
- Investigators
- Patrick Holt, MD, Principal investigator, Telethon Institute for Child Health ResearchPeter Sly, MD, Study chair, Telethon Institute for Child Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346398
- Sponsor's protocol ID
- DAIT ITN025AD
- Acronym
- GPAC
- Status last verified
- Mar 2017
- First submitted
- 27 Jun 2006
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data access is provided to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools available to researchers; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal that makes data from the consortium's clinical trials publicly available.
Publications
Mascarell L, Van Overtvelt L, Moingeon P. Novel ways for immune intervention in immunotherapy: mucosal allergy vaccines. Immunol Allergy Clin North Am. 2006 May;26(2):283-306, vii-viii. doi: 10.1016/j.iac.2006.02.009.
PubMed 16701145Nelson HS. Advances in upper airway diseases and allergen immunotherapy. J Allergy Clin Immunol. 2006 May;117(5):1047-53. doi: 10.1016/j.jaci.2005.12.1306. Epub 2006 Mar 6.
PubMed 16675331Holt PG, Sly PD, Sampson HA, Robinson P, Loh R, Lowenstein H, Calatroni A, Sayre P. Prophylactic use of sublingual allergen immunotherapy in high-risk children: a pilot study. J Allergy Clin Immunol. 2013 Oct;132(4):991-3.e1. doi: 10.1016/j.jaci.2013.04.049. Epub 2013 Jun 12. No abstract available.
PubMed 23768574
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)
- ClinicalTrials.gov ID
- NCT00346398
- Acronym / sponsor ID
- GPAC / DAIT ITN025AD
- Conditions
- Asthma, Allergic Sensitization
- Keywords
- asthma, allergen, allergic disease, allergen immunotherapy, allergic sensitization, atopic dermatitis, eczema, food allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Study start
- May 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Posted 16 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.
Detailed description
Researchers suspect that allergies to common inhaled allergens (such as house dust mite, cat dander, and grass pollens) are a major cause of childhood asthma. Recent evidence suggests that if allergies to inhaled allergens are prevented, this can cause changes in the immune system that may inhibit the development of asthma. Although strategies to prevent allergies generally focus on avoiding the allergen, complete avoidance of the common allergens linked to asthma would require extreme measures and is impractical.
Oral mucosal immunoprophylaxis (OMIP) therapy is an allergy treatment that can induce long-lasting immune tolerance in people already suffering from allergies. By exposing the patient to small, repeated, but increasing doses of the problem allergen over a long period of time, the patient's immune system is eventually desensitized to that particular allergen. OMIP therapy has been shown to be safe in children as young as 2 years old. This study will evaluate if OMIP therapy against common inhaled allergens is safe and effective in preventing the development of asthma in children at high risk for developing the disease. Children enrolled in this study have been diagnosed with eczema or food allergies and have a family history of eczema, allergic rhinitis, or asthma.
There are two groups in this study. The experimental arm participants will receive OMIP therapy (a mixture of house dust mite, cat, and timothy grass allergens) as daily oral drops under the tongue for 1 year; Placebo arm participants will receive an allergen free placebo solution. Participants will be followed for an additional 3 years to see whether they develop allergies or asthma and to determine how OMIP affects their immune system's response to allergens. There will be 5 study visits in the first year and 6 visits over the next 3 years. At all visits, participants will be assessed for allergy/asthma symptoms, will be asked to complete questionnaires, and may be asked to provide blood or saliva samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral mucosal immunoprophylaxis (OMIP) | Experimental | Biological: Oral mucosal immunoprophylaxis (OMIP)Participants are administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants are administered, via the same route as the experimental group, an oral placebo solution daily for 12 months. |
Who may qualify
- Ages
- 12 to 30 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosed with eczema (atopic dermatitis)
- Family history of eczema, allergic rhinitis, or asthma
- Allergy to one or more of the following: egg white, cow's milk, peanut, or soybean
- Weigh at least 9.5 kg (20.9 lbs)
- Parent or guardian willing to provide informed consent
Key exclusion criteria (10 listed)
- Allergy to house dust mite, cat, or timothy grass
- Born prematurely (before 36th week's gestation)
- Previous diagnosis of asthma OR have had 3 or more distinct episodes of wheeze during the first year of life
- Chronic pulmonary disease
- Chronic disease requiring therapy
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 |
|---|---|---|
| Oral mucosal immunoprophylaxis (OMIP)Also: Allergen immunotherapyOMIP consists of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. | Biological | Oral mucosal immunoprophylaxis (OMIP) |
| PlaceboThe placebo consists of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. | Biological | Placebo |
Primary outcome
Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion
Time frame: Three years (36 months) after Treatment Completion
Allergic sensitization is defined as a positive serum allergen specific Immunoglobulin E (IgE) CAP test[1] or a positive allergy skin prick test[2]. Not experiencing allergic sensitization is the better outcome for this measure. 1. A positive serum allergen specific IgE CAP (ImmunoCAP) test result is defined by a result >= 0.35 kU/L. Higher scores indicate greater allergic sensitization. 2. A positive skin prick test is defined as a wheal diameter that is 3 mm larger than that produced by a negative control. Higher wheal sizes indicate greater allergic reaction or sensitization.
2 secondary outcomes
Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion
Time frame: Three years (36 months) after Treatment Completion
Time to First Onset of Asthma
Time frame: From Treatment Initiation to Month 36 Status Post Treatment Completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16701145Mascarell L, Van Overtvelt L, Moingeon P. Novel ways for immune intervention in immunotherapy: mucosal allergy vaccines. Immunol Allergy Clin North Am. 2006 May;26(2):283-306, vii-viii. doi: 10.1016/j.iac.2006.02.009.
- Background: PubMed 16675331Nelson HS. Advances in upper airway diseases and allergen immunotherapy. J Allergy Clin Immunol. 2006 May;117(5):1047-53. doi: 10.1016/j.jaci.2005.12.1306. Epub 2006 Mar 6.
- Results publication: PubMed 23768574Holt PG, Sly PD, Sampson HA, Robinson P, Loh R, Lowenstein H, Calatroni A, Sayre P. Prophylactic use of sublingual allergen immunotherapy in high-risk children: a pilot study. J Allergy Clin Immunol. 2013 Oct;132(4):991-3.e1. doi: 10.1016/j.jaci.2013.04.049. Epub 2013 Jun 12. No abstract available.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
- Immune Tolerance Network (ITN) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data access is provided to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools available to researchers; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal that makes data from the consortium's clinical trials publicly available.
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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.
Patrick Holt, MD principal investigator
Telethon Institute for Child Health Research
Peter Sly, MD study chair
Telethon Institute for Child Health Research
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral mucosal immunoprophylaxis (OMIP) in people with Asthma and Allergic Sensitization, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 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 5 inclusion and 10 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 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 16 Dec 2013). 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?
Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion (time frame: Three years (36 months) after Treatment Completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00346398, which also lists 3 linked publications.
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 1 May 2017.