CoughNCT02492126
Esophageal Motility in Reflux Induced Cough
An observational study of Cough, run by Mayo Clinic at 1 site in United States.
Trial summary
To determine whether contraction abnormalities in the esophagus plays a role in gastroesophageal reflux induced cough, and thus cough severity in patients with chronic cough. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cough
- What is being tested?
- Citric Acid
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic cough patients
Who may be able to join
- Adult patients (ages 18-75 years old)
- Cough for more than 8 weeks
- Additional clinical evaluation of cough including a complete pulmonary function test with methacholine challenge and a high resolution CT scan of the chest.
- Ability to understand the purpose and nature of the study
- Willingness to participate and provide consent form
Who cannot join
- Actively smoke in the preceding 6 months.
- Recent respiratory tract infection (<4 weeks).
- Drink above the recommended safe alcohol limit (21 units per week).
- History of respiratory or gastrointestinal malignancies.
- Previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy).
- Subjects with established and significant cardiac, pulmonary, or neurological disorders as deemed by the clinician or study personnel
Show all 13Show fewer
- Use of angiotensin converting enzyme inhibitors
- Use of H2 blockers or proton pump inhibitors in the seven days prior to reflux testing (impedance/pH), or inability to withhold such medications for the duration of the study
- Women of childbearing potential, using adequate birth control. Adequate birth control includes: (i) hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants; (ii) barrier methods (such as, a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm); (iii) intrauterine device (IUD); or (iv) abstinence (no sex). Adequate birth control must be maintained for the duration of the study. Women not using adequate birth control will be excluded from the study, as funding for the pregnancy tests was not included in the small grant awarded for this study.
- Nursing mothers will be excluded.
- Persons with allergies to citrus will be excluded.
- Inability to understand the purpose and nature of the study
- Unwillingness to participate and provide consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Cough and Reflux: Is Esophageal Motility the Key?
To determine whether contraction abnormalities in the esophagus plays a role in gastroesophageal reflux induced cough, and thus cough severity in patients with chronic cough.
- Conditions
- Cough
- Being tested
- Citric Acid
- Keywords
- Chronic Cough, Gastroesophageal Reflux, Esophageal Motility, Cough Sensitivity
- Medical subject headings
- Cough, Chronic Cough, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citric AcidOther
Subjects will undergo cough reflex sensitivity testing to citric acid.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Cough | Subjects with chronic cough will undergo cough reflex sensitivity testing to citric acid. The dose, starting at 0.03 mol/L citric acid will be administered as single breath inhalations using flow-limited calibrated pots and a dosimeter with 3 placebo inhalations of normal saline randomly interspersed. Following each inhalation, the number of coughs in the subsequent 15 seconds will be counted and recorded. The challenge will be terminated once the citric acid has induced 5 or more coughs. Receives: Other: Citric Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with reflux related cough
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 87 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 DeVault, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492126
- Sponsor's protocol ID
- 15-002020
- Status last verified
- Oct 2020
- First submitted
- 2 Jul 2015
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Cough and Reflux: Is Esophageal Motility the Key?
- ClinicalTrials.gov ID
- NCT02492126
- Acronym / sponsor ID
- 15-002020
- Conditions
- Cough
- Keywords
- Chronic Cough, Gastroesophageal Reflux, Esophageal Motility, Cough Sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 Jul 2015 (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.
To determine whether contraction abnormalities in the esophagus plays a role in gastroesophageal reflux induced cough, and thus cough severity in patients with chronic cough.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Cough | – | Other: Citric AcidSubjects with chronic cough will undergo cough reflex sensitivity testing to citric acid. The dose, starting at 0.03 mol/L citric acid will be administered as single breath inhalations using flow-limited calibrated pots and a dosimeter with 3 placebo inhalations of normal saline randomly interspersed. Following each inhalation, the number of coughs in the subsequent 15 seconds will be counted and recorded. The challenge will be terminated once the citric acid has induced 5 or more coughs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic cough patients
Key inclusion criteria (5 listed)
- Adult patients (ages 18-75 years old)
- Cough for more than 8 weeks
- Additional clinical evaluation of cough including a complete pulmonary function test with methacholine challenge and a high resolution CT scan of the chest.
- Ability to understand the purpose and nature of the study
- Willingness to participate and provide consent form
Key exclusion criteria (13 listed)
- Actively smoke in the preceding 6 months.
- Recent respiratory tract infection (<4 weeks).
- Drink above the recommended safe alcohol limit (21 units per week).
- History of respiratory or gastrointestinal malignancies.
- Previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy).
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 |
|---|---|---|
| Citric AcidSubjects will undergo cough reflex sensitivity testing to citric acid. | Other | Chronic Cough |
Primary outcome
Percentage of subjects with reflux related cough
Time frame: 24 hrs
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 30 Oct 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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 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 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 5 inclusion and 13 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 30 Oct 2020. 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?
Percentage of subjects with reflux related cough (time frame: 24 hrs). 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 30 Oct 2020.