Cough Reflex Sensitivity and Bronchial Hyper-responsiveness
2017년 2월 16일 업데이트: Kenneth R. DeVault, M.D., Mayo Clinic
Pilot Studies Evaluating Cough Reflex Sensitivity and Bronchial Hyper-responsiveness: The Road to Cough and Wheeze in Patients With Gastroesophageal Reflux.
The aim of this study is to provide pilot data on the possible gastrointestinal predictors of respiratory hyper-responsiveness and how these relate to the clinical sub-types of gastroesophageal reflux disease (GERD) and visceral acid hypersensitivity.
연구 개요
상태
완전한
상세 설명
This study recruited participants into three groups: reflux patients with non-erosive disease (NERD) with abnormal levels of acid reflux, NERD patients with normal levels of reflux and healthy volunteers.
Participants were assessed for cough reflex sensitivity (CRS) to citric acid and bronchial-hyperresponsiveness (BHR) to methacholine challenge, both before (baseline) and after esophageal acid infusion (HCl, 0.15M) or normal saline control (8ml/min).
The order of CRS and BHR was randomized, as was the order of the acid/saline infusions.
연구 유형
관찰
등록 (실제)
24
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic Florida
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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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
This study will recruit participants into three groups ages 18-60 years: 12 reflux patients with non-erosive disease (NERD) with abnormal levels of acid reflux, 12 NERD patients with normal levels of reflux and 12 healthy volunteers.
설명
Inclusion Criteria:
- symptomatic reflux (i.e., one symptom at least one day a week, with at least 'moderate' severity)
- no evidence of esophagitis
- non-smokers
Exclusion Criteria:
- previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy
- active peptic ulcer disease
- Zollinger Ellison Syndrome
- Barrett's esophagus
- eosinophilic esophagitis
- cardiac disease
- diabetes or neurological deficit
- use of tricyclics
- selective serotonin reuptake inhibitors
- narcotics or benzodiazepines
- current use of medications that may affect symptoms of perception,lower esophageal sphincter basal pressure, acid clearance time or acid suppression
- antibiotics within 60 days
- Nursing mothers will be excluded
- allergies to citrus
- asthma
- chronic lung disease
- heart attack or stroke within the last three months
- hypersensitivity to methacholine products
- know aortic aneurysm
- uncontrolled hypertension (defined as systolic pressure greater than 200 or diastolic greater than 100)
- reduced pulmonary function test (forced expiratory volume in one second (FEV1) or the FEV1 to forced vital capacity (FVC) ratio (FEV1/FVC) of less that 70% of predicted value)
- None of the controls will have any GERD symptoms or ever used antireflux treatment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Healthy Volunteers
Subjects in this arm were healthy volunteers.
Subjects underwent both Cough Reflex Sensitivity and the Methacholine Challenge procedures.
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Subjects inhaled increasing concentrations of citric acid, which induces coughing in a dose-dependent, reproducible matter.
Following each inhalation, the number of coughs in the subsequent 15 seconds was counted and recorded.
The challenge was terminated once the citric acid induced 5 or more coughs and the logarithmic (base 10) concentration provoking 5 coughs was recorded.
A baseline spirometry was used to assess how well the participant's lungs work by measuring how much air was inhale, how much was exhale and how quickly the participant exhaled.
If this was normal, the subject inhaled slowly and deeply the methacholine test solution from a nebulizer and was told to hold their breath for 5 seconds.
This was repeated until 5 inhalations were performed in no more than two minutes.
|
|
Non-erosive reflux disease with reflux
Subjects enrolled in this arm had non-erosive reflux disease with reflux (heartburn) for at least 6 of the preceding 12 months.
Subjects underwent both Cough Reflex Sensitivity and the Methacholine Challenge procedures.
|
Subjects inhaled increasing concentrations of citric acid, which induces coughing in a dose-dependent, reproducible matter.
Following each inhalation, the number of coughs in the subsequent 15 seconds was counted and recorded.
The challenge was terminated once the citric acid induced 5 or more coughs and the logarithmic (base 10) concentration provoking 5 coughs was recorded.
A baseline spirometry was used to assess how well the participant's lungs work by measuring how much air was inhale, how much was exhale and how quickly the participant exhaled.
If this was normal, the subject inhaled slowly and deeply the methacholine test solution from a nebulizer and was told to hold their breath for 5 seconds.
This was repeated until 5 inhalations were performed in no more than two minutes.
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Non-erosive reflux disease without reflux
Subjects enrolled in this arm had non-erosive reflux disease with normal levels of reflux (heartburn).
Subjects underwent both Cough Reflex Sensitivity and the Methacholine Challenge procedures.
|
Subjects inhaled increasing concentrations of citric acid, which induces coughing in a dose-dependent, reproducible matter.
Following each inhalation, the number of coughs in the subsequent 15 seconds was counted and recorded.
The challenge was terminated once the citric acid induced 5 or more coughs and the logarithmic (base 10) concentration provoking 5 coughs was recorded.
A baseline spirometry was used to assess how well the participant's lungs work by measuring how much air was inhale, how much was exhale and how quickly the participant exhaled.
If this was normal, the subject inhaled slowly and deeply the methacholine test solution from a nebulizer and was told to hold their breath for 5 seconds.
This was repeated until 5 inhalations were performed in no more than two minutes.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in cough reflex sensitivity (CRS)
기간: baseline, approximately 4 weeks
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baseline, approximately 4 weeks
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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 (실제)
2012년 12월 1일
기본 완료 (실제)
2016년 2월 1일
연구 완료 (실제)
2016년 2월 1일
연구 등록 날짜
최초 제출
2013년 1월 24일
QC 기준을 충족하는 최초 제출
2013년 1월 24일
처음 게시됨 (추정)
2013년 1월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 2월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 2월 16일
마지막으로 확인됨
2017년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 11-006873
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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