AsthmaPhase 2PAPANCT05113394
Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy
A Phase 2 study testing HDM sublingual Immunotherapy in people with Asthma and Allergy, run by Boston Children's Hospital.
Trial summary
To establish efficacy and safety of HDM sublingual Immunotherapy (HDM-SLIT) by comparing Odactra and placebo, when given sublingually for 3 years to high risk infants aged between 6 to 12 months at enrollment in preventing the development of asthma, assessed 1.5 years after discontinuation of treatment. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- What is being tested?
- HDM sublingual Immunotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 1 Aug 2029
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 6 to 12 months of age
- history of physician diagnosed atopic dermatitis OR
- allergen sensitization OR
- family history of asthma or allergy
Who cannot join
- Evidence of sensitization to house dust mite (SPT ≥3 mm OR sIgE (> 0.35 kU/L)
- Prematurity (<37 weeks)
- Failure to thrive
- Need for oxygen for more than 5 days in the neonatal period
- history of intubation or mechanical ventilation
About this study
To establish efficacy and safety of HDM sublingual Immunotherapy (HDM-SLIT) by comparing Odactra and placebo, when given sublingually for 3 years to high risk infants aged between 6 to 12 months at enrollment in preventing the development of asthma, assessed 1.5 years after discontinuation of treatment.
Read the detailed description
Aim to prevent the development of asthma in children by intervening at a time when the developing system in still amenable to immune modulation, by using the only therapy that has proven ability to change the natural history of allergic diseases and induce clinical remission. We hypothesize that three years of HDM Immunotherapy in high-risk infants will prevent the development of asthma assessed over a period of 1.5 years after discontinuation of treatment and HDM immunotherapy will result in (a) a significant reduction in the number and pathogenic features of HDM-reactive TH2 cells, and (b) an increase in the numbers of HDM-reactive TH and TREG cells expressing the interferon-response signature. The study is a Randomized (1:1), double blinded, placebo controlled, parallel arms, multi-site, Phase II study with a 3 year treatment phase and further 1.5 year follow-up phase. The study duration for each participant is 4.5 years. Overall study duration is 84 months (7 years); which include 9 months preparation and regulatory approvals, 15 months accrual, 36 months treatment and 18 months follow-up observation period.
- Being tested
- HDM sublingual Immunotherapy, Placebo
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM sublingual ImmunotherapyDrug
Also called dust mite sublingual immunotherapy
HDM-SLIT tablet (Odactra®/Acarizax®) is a rapidly dissolving, freeze-dried, oral lyophilizate for oromucosal treatment, which contains a 1:1 mixture of two allergen extracts derived for the cultivated house dust mites, D. pteronyssinus and D. farinae. These species are included in SLIT tablet and subcutaneous immunotherapy administered for the treatment of allergic rhinitis and asthma in the pediatric and adult populations. The tablet dissolves within seconds after contact with a wet surface such as the oral mucosa. Participants will be administered the drug sublingually for 3 years.
PlaceboDrug
Also called placebo dust mite sublingual immunotherapy
Placebo sublingual therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | HDM sublingual Immunotherapy (HDM-SLIT) with Odactra® for 3 years to high-risk infants aged between 6 to 12 months at enrollment in preventing the development of asthma, assessed 1.5 years after discontinuation of treatment. Receives: Drug: HDM sublingual Immunotherapy |
| Placebo arm | Placebo comparator | Placebo administered sublingually for 3 years to high-risk infants aged between 6 to 12 months with outcome of asthma development assessed 1.5 years after discontinuation of treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Asthma
asthma diagnosis
Measured: 1.5 years after discontinuation of 3 years of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Why it stopped: Awaiting funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Model description
- Randomized (1:1), double blinded, placebo controlled, parallel arms, multi-site, Phase II study; 3 year treatment phase with further 1.5 year follow-up phase.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, University of North Carolina, Chapel Hill, George Washington University, Emory University, University of Southampton, Imperial College London
- Responsible party
- Principal investigator, Wanda Phipatanakul, Harvard Medical School (HMS and HSDM)
- Investigators
- Wanda Phipatanakul, MD, MS, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113394
- Acronym
- PAPA
- Status last verified
- Nov 2024
- First submitted
- 19 Oct 2021
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy
- ClinicalTrials.gov ID
- NCT05113394
- Acronym / sponsor ID
- PAPA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Awaiting funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, University of North Carolina, Chapel Hill, George Washington University, Emory University, University of Southampton, Imperial College London
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish efficacy and safety of HDM sublingual Immunotherapy (HDM-SLIT) by comparing Odactra and placebo, when given sublingually for 3 years to high risk infants aged between 6 to 12 months at enrollment in preventing the development of asthma, assessed 1.5 years after discontinuation of treatment.
Detailed description
Aim to prevent the development of asthma in children by intervening at a time when the developing system in still amenable to immune modulation, by using the only therapy that has proven ability to change the natural history of allergic diseases and induce clinical remission. We hypothesize that three years of HDM Immunotherapy in high-risk infants will prevent the development of asthma assessed over a period of 1.5 years after discontinuation of treatment and HDM immunotherapy will result in (a) a significant reduction in the number and pathogenic features of HDM-reactive TH2 cells, and (b) an increase in the numbers of HDM-reactive TH and TREG cells expressing the interferon-response signature. The study is a Randomized (1:1), double blinded, placebo controlled, parallel arms, multi-site, Phase II study with a 3 year treatment phase and further 1.5 year follow-up phase. The study duration for each participant is 4.5 years. Overall study duration is 84 months (7 years); which include 9 months preparation and regulatory approvals, 15 months accrual, 36 months treatment and 18 months follow-up observation period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized (1:1), double blinded, placebo controlled, parallel arms, multi-site, Phase II study; 3 year treatment phase with further 1.5 year follow-up phase.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: HDM sublingual ImmunotherapyHDM sublingual Immunotherapy (HDM-SLIT) with Odactra® for 3 years to high-risk infants aged between 6 to 12 months at enrollment in preventing the development of asthma, assessed 1.5 years after discontinuation of treatment. |
| Placebo arm | Placebo comparator | Drug: PlaceboPlacebo administered sublingually for 3 years to high-risk infants aged between 6 to 12 months with outcome of asthma development assessed 1.5 years after discontinuation of treatment. |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 6 to 12 months of age
- history of physician diagnosed atopic dermatitis OR
- allergen sensitization OR
- family history of asthma or allergy
Key exclusion criteria (5 listed)
- Evidence of sensitization to house dust mite (SPT ≥3 mm OR sIgE (> 0.35 kU/L)
- Prematurity (<37 weeks)
- Failure to thrive
- Need for oxygen for more than 5 days in the neonatal period
- history of intubation or mechanical ventilation
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 |
|---|---|---|
| HDM sublingual ImmunotherapyAlso: dust mite sublingual immunotherapyHDM-SLIT tablet (Odactra®/Acarizax®) is a rapidly dissolving, freeze-dried, oral lyophilizate for oromucosal treatment, which contains a 1:1 mixture of two allergen extracts derived for the cultivated house dust mites, D. pteronyssinus and D. farinae. These species are included in SLIT tablet and subcutaneous immunotherapy administered for the treatment of allergic rhinitis and asthma in the pediatric and adult populations. The tablet dissolves within seconds after contact with a wet surface such as the oral mucosa. Participants will be administered the drug sublingually for 3 years. | Drug | Experimental arm |
| PlaceboAlso: placebo dust mite sublingual immunotherapyPlacebo sublingual therapy | Drug | Placebo arm |
Primary outcome
Number of Participants with Asthma
Time frame: 1.5 years after discontinuation of 3 years of treatment
asthma diagnosis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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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.
Wanda Phipatanakul, MD, MS principal investigator
Boston Children's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDM sublingual Immunotherapy in people with Asthma and Allergy, run by Boston Children's Hospital.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Nov 2024. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 Asthma (time frame: 1.5 years after discontinuation of 3 years of treatment). 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 26 Nov 2024.