Cough Reflex Sensitivity and Bronchial Hyper-responsiveness
2017年2月16日 更新者：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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
観察的
入学 (実際)
24
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Florida
-
Jacksonville、Florida、アメリカ、32224
- Mayo Clinic Florida
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～60年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Healthy Volunteers
Subjects in this arm were healthy volunteers.
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.
|
|
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.
|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in cough reflex sensitivity (CRS)
時間枠：baseline, approximately 4 weeks
|
baseline, approximately 4 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2012年12月1日
一次修了 (実際)
2016年2月1日
研究の完了 (実際)
2016年2月1日
試験登録日
最初に提出
2013年1月24日
QC基準を満たした最初の提出物
2013年1月24日
最初の投稿 (見積もり)
2013年1月29日
学習記録の更新
投稿された最後の更新 (実際)
2017年2月17日
QC基準を満たした最後の更新が送信されました
2017年2月16日
最終確認日
2017年2月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 11-006873
個々の参加者データ (IPD) の計画
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いいえ
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