- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00405509
The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years
The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to <14 Years
연구 개요
상세 설명
Leukotrienes are chemicals that are naturally made by your body. Leukotrienes are increased in the bodies of adults and children with asthma and allergies and cause some of the symptoms of these diseases. Leukotrienes are increased in the bodies of adults who have common colds and are believed to cause some of the symptoms of the common cold. It is not known if increases in leukotrienes are related to the symptoms of the common cold in children. There are also genes that may control levels of leukotrienes and other chemicals in your body during the common cold. If you enroll your child in this study, he/she will be tested for allergies and for genes that may control the levels of leukotrienes and other chemicals.
STUDY DESIGN:
There will be 40 subjects enrolled into the study between the ages of 6 to < 14 years of age. However, approximately 80 participants may have to sign the consent form and undergo screening activities in order enroll these 40 subjects. The study will last approximately 1 month and will require you and your child to return to our clinic approximately 7 times over the study duration. You and your child will be required to return to our clinic six days in a row for testing.
Testing will include skin testing for allergies, nasal secretion collection, and skin cell collection.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15212
- Allegheny General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Children 6 to < 14 years of age.
- Common cold symptoms for less than 24 hours.
- At least 2 of the following 8 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, and sneezing.
Exclusion Criteria:
- Investigational medication in past 30 days.
- History of persistent asthma or other chronic diseases.
- Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.
- Patients with evidence of significant nasal septal deviation.
- Patients with a positive rapid antigen test for streptococcal infection.
- Common cold symptoms for more than 24 hours.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
---|
Confirmed respiratory virus
|
Unconfirmed respiratory infection
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Local Leukotriene Levels
기간: once a day for 6 days and on day 30
|
nasal secretions were collected once a day for the first six days of the respiratory infection and on day 30 then measured for leukotriene levels
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once a day for 6 days and on day 30
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Nasal Secretion Weights
기간: each day for 5 days
|
Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight
|
each day for 5 days
|
Severity of Symptom Scores - COUGH
기간: once a day for six days and on day 30
|
Cough symptoms were rated by the participant each day for 6 days and on day 30.
Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.
|
once a day for six days and on day 30
|
Severity of Symptom Score - NASAL CONGESTION
기간: once a day for six days and on day 30
|
nasal congestion symptoms were rated by the participant once a day for six days and on day 30.
Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.
|
once a day for six days and on day 30
|
Severity of Symptom Score - SNEEZING
기간: once a day for six days and on Day 30
|
Sneezing symptoms were rated by participants once a day for six days and on Day 30, symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.
|
once a day for six days and on Day 30
|
공동 작업자 및 조사자
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .