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Childhood Asthma Reduction Study

Background:

- Cockroach allergies are an important risk factor for asthma in inner-city households, especially in children. A new method for killing cockroaches may help children who live in households that have high numbers of cockroaches. Because most public health treatments target more than just cockroaches, this method could lower the costs of treating childhood allergies and asthma by focusing on the most likely source of the allergy.

Objectives:

- To test a new cockroach-killing method designed to reduce asthma in children exposed to cockroaches.

Eligibility:

  • Children 5 to 14 years of age who have moderate to severe asthma.
  • Children must live in a household that has a high number of cockroaches.

Design:

  • Participants will be screened with a phone call and an initial home visit.
  • Study doctors will place cockroach traps, and return after 3 days to check the number of roaches caught and killed. Dust samples will be collected from the house.
  • Participants will have blood and lung function tests, and will be tested for allergies (including cockroach allergies).
  • Some households will be treated for cockroaches at regular intervals, or more frequently if required by the study doctors.
  • Participants will have regular checkup visits in their homes at months 1, 3, 6, 9, and 12 and short phone call interviews at months 2, 4, 6, 8 and 10 to study their asthma symptoms. The home visits will also check the cockroach levels in the house.

연구 개요

상태

빼는

정황

상세 설명

Asthma is the most prevalent chronic childhood condition and is the most frequent cause of hospitalization among children. There are about 6.7 million children in the U.S. who currently have asthma, and nearly two of every three of these children had at least one attack in the past 12 months. Evidence suggests that exposure to cockroach allergen might be the most important risk factor for asthma in inner-city households. An environmental intervention targeting only cockroach allergen could potentially provide cost savings in a public health program over high cost multi-component interventions, if it could be shown to reduce asthma morbidity.

The primary objective of the Childhood Asthma REduction Study (CARES) is to evaluate the effectiveness of a novel cockroach eradication method, shown in prior studies to drastically decrease cockroach allergen levels, in reducing asthma morbidity in children with moderate to severe asthma who are both allergic and exposed to cockroach allergen. Additionally, the study will characterize relationships between cockroach infestation and other environmental allergen exposures, and asthma morbidity, as well as consider dynamic relationships between cockroach counts and observed allergen reductions over time; and use study data to identify mechanisms such as cleaning behaviors that may influence those relationships.

These objectives will be addressed through a prospective, randomized controlled, multi-site intervention trial in which 414 eligible children age 5 to 14 years who live in households with a confirmed trap count of 30 or more cockroaches over a 3-day period, are randomly assigned to one of two treatment groups. Treatment will be implemented at multiple intervals in the homes of children assigned to the intervention group. Children in both the intervention and control groups will receive clinical evaluations for asthma, home assessments of allergen exposures, educational materials on allergen exposures and asthma, and information on study results. Following 12-months of active data collection, the extermination treatment will be made available to the homes of children in the control group. The target sample size is 372 participants completing the study, equally divided into the two arms. Home environmental assessments following the enrollment visit will take place at enrollment, 1, 3, 6, 9, and 12 months. Clinical assessments will also be conducted in the home at enrollment and the 12-month visit. Primary outcome data will be collected during scheduled follow up phone calls every two months.

연구 유형

중재적

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

5년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

  • INCLUSION CRITERIA:

A child will be included in this study if the following criteria apply:

(Assessed during phone screening)

  • Aged 5 to 14 years of age
  • Physician diagnosis of asthma for at least one year prior to prescreening
  • Parent/guardian able and willing to provide consent; child able and willing to provide assent
  • Primary caretaker and child are able to speak English or Spanish
  • Moderate to severe asthma as defined by the child experiencing one of the following:

    • One overnight hospitalization for asthma within the past 6 months,

OR

--Two unscheduled clinic or emergency department visits for asthma within the past 12 months

-Sleeps in the target home greater than or equal to 5 nights per week

(Assessed at beginning of enrollment/baseline visit)

  • Target home has greater than or equal to 30 cockroaches trapped in a 3 day period
  • Positive ImmunoCAP Rapid test result to cockroach allergen

EXCLUSION CRITERIA:

A child will be excluded from this study if the following criteria apply, as determined in the screening phone call and/or confirmed at the baseline visit:

  • The child has other serious medical or chronic illnesses, other than asthma, such as:

    • Any hematologic, metabolic/endocrine, respiratory (other than asthma), cardiac or neurologic disorder requiring daily medications;
    • Any severe behavioral problem that prohibits the child or the child s caregiver from answering questions or following instructions;
    • Any autoimmune disease including rheumatoid arthritis, lupus, and myositis;
    • Any immune deficiency;
    • Any other serious medical condition such as juvenile diabetes mellitus, hypothyroidism, hyperthyroidism, cerebral palsy, hyperimmunoglobulin E syndrome, or diagnosed allergic bronchopulmonary aspergillosis.
  • Plans to move within the 12 months of study enrollment
  • Has no caregiver with access to a phone

Sibling or other household member currently participating in the study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
Change in the mean number of maximum asthma symptom days.

2차 결과 측정

결과 측정
Asthma-related medical care resource utilization, Lung function, Medication use, Cockroach Number and Allergen Reductions.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 9월 4일

기본 완료 (실제)

2013년 11월 15일

연구 완료 (실제)

2013년 11월 15일

연구 등록 날짜

최초 제출

2011년 9월 10일

QC 기준을 충족하는 최초 제출

2011년 11월 9일

처음 게시됨 (추정)

2011년 11월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 12월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 12월 6일

마지막으로 확인됨

2013년 11월 15일

추가 정보

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. .

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