Gastroesophageal Reflux DiseaseNCT01777867
Cough Reflex Sensitivity and Bronchial Hyper-responsiveness
An observational study of Gastroesophageal Reflux Disease and Chronic Cough, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease, Chronic Cough, Broncho-hyperreactivity
- What is being tested?
- Cough Reflex Sensitivity and Methacholine Challenge
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- symptomatic reflux (i.e., one symptom at least one day a week, with at least 'moderate' severity)
- no evidence of esophagitis
- non-smokers
Who cannot join
- previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy
- active peptic ulcer disease
- Zollinger Ellison Syndrome
- Barrett's esophagus
- eosinophilic esophagitis
- cardiac disease
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Cough Reflex Sensitivity, Methacholine Challenge
- Medical subject headings
- Gastroesophageal Reflux, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough Reflex SensitivityProcedure or surgery
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.
Methacholine ChallengeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Subjects in this arm were healthy volunteers. Subjects underwent both Cough Reflex Sensitivity and the Methacholine Challenge procedures. Receives: Procedure: Cough Reflex Sensitivity; Procedure: Methacholine Challenge | |
| 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. Receives: Procedure: Cough Reflex Sensitivity; Procedure: Methacholine Challenge | |
| 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. Receives: Procedure: Cough Reflex Sensitivity; Procedure: Methacholine Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cough reflex sensitivity (CRS)
Measured: baseline, approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Principal investigator, Kenneth R. DeVault, M.D., Mayo Clinic
- Investigators
- Kenneth R. DeVault, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777867
- Sponsor's protocol ID
- 11-006873
- Status last verified
- Feb 2017
- First submitted
- 24 Jan 2013
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies Evaluating Cough Reflex Sensitivity and Bronchial Hyper-responsiveness: The Road to Cough and Wheeze in Patients With Gastroesophageal Reflux.
- ClinicalTrials.gov ID
- NCT01777867
- Acronym / sponsor ID
- 11-006873
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- Dec 2012 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Procedure: Cough Reflex Sensitivity, Procedure: Methacholine ChallengeSubjects in this arm were healthy volunteers. Subjects underwent both Cough Reflex Sensitivity and the Methacholine Challenge procedures. |
| Non-erosive reflux disease with reflux | – | Procedure: Cough Reflex Sensitivity, Procedure: Methacholine ChallengeSubjects 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. |
| Non-erosive reflux disease without reflux | – | Procedure: Cough Reflex Sensitivity, Procedure: Methacholine ChallengeSubjects 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- symptomatic reflux (i.e., one symptom at least one day a week, with at least 'moderate' severity)
- no evidence of esophagitis
- non-smokers
Key exclusion criteria (22 listed)
- previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy
- active peptic ulcer disease
- Zollinger Ellison Syndrome
- Barrett's esophagus
- eosinophilic esophagitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cough Reflex SensitivitySubjects 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. | Procedure or surgery | Healthy Volunteers, Non-erosive reflux disease with reflux, Non-erosive reflux disease without reflux |
| Methacholine ChallengeA 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. | Procedure or surgery | Healthy Volunteers, Non-erosive reflux disease with reflux, Non-erosive reflux disease without reflux |
Primary outcome
Change in cough reflex sensitivity (CRS)
Time frame: baseline, approximately 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth R. DeVault, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Chronic Cough, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cough reflex sensitivity (CRS) (time frame: baseline, approximately 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.