Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study (GPAC)
A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Oral mucosal immunoprophylaxis (OMIP)
Participants are administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months.
|
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.
다른 이름들:
|
|
위약 비교기: Placebo
Participants are administered, via the same route as the experimental group, an oral placebo solution daily for 12 months.
|
The placebo consists of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion
기간: 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.
|
Three years (36 months) after Treatment Completion
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion
기간: Three years (36 months) after 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.
|
Three years (36 months) after Treatment Completion
|
|
Time to First Onset of Asthma
기간: From Treatment Initiation to Month 36 Status Post Treatment Completion
|
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.
|
From Treatment Initiation to Month 36 Status Post Treatment Completion
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Patrick Holt, MD, Telethon Institute for Child Health Research
- 연구 의자: Peter Sly, MD, Telethon Institute for Child Health Research
간행물 및 유용한 링크
일반 간행물
- 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.
- Nelson 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.
- Holt 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- DAIT ITN025AD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
연구 데이터/문서
-
개별 참가자 데이터 세트
정보 식별자: SDY545정보 댓글: ImmPort study identifier is SDY545.
-
Study summary, -design with synopsis, -adverse events, -assessment, -medications, -demographics, -lab tests, -files, et al.
정보 식별자: SDY545정보 댓글: ImmPort study identifier is SDY545.
-
개별 참가자 데이터 세트
정보 식별자: ITN025AD정보 댓글: TrialShare is the ITN clinical trials research portal available to the public.
-
Study overview with synopsis, -navigator, -schedule of events, -data and reports, biospecimens and availability.
정보 식별자: ITN025AD정보 댓글: TrialShare study identifier is ITN025AD.
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .