Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
87 participants
OBSERVATIONAL
2016-01-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Citric Acid
Subjects will undergo cough reflex sensitivity testing to citric acid.
Interventions
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Citric Acid
Subjects will undergo cough reflex sensitivity testing to citric acid.
Eligibility Criteria
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Inclusion Criteria
2. Cough for more than 8 weeks
3. Additional clinical evaluation of cough including a complete pulmonary function test with methacholine challenge and a high resolution CT scan of the chest.
4. Ability to understand the purpose and nature of the study
5. Willingness to participate and provide consent form
Exclusion Criteria
2. Recent respiratory tract infection (\<4 weeks).
3. Drink above the recommended safe alcohol limit (21 units per week).
4. History of respiratory or gastrointestinal malignancies.
5. Previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy).
6. Subjects with established and significant cardiac, pulmonary, or neurological disorders as deemed by the clinician or study personnel
7. Use of angiotensin converting enzyme inhibitors
8. 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
9. 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.
10. Nursing mothers will be excluded.
11. Persons with allergies to citrus will be excluded.
12. Inability to understand the purpose and nature of the study
13. Unwillingness to participate and provide consent form
18 Years
75 Years
ALL
No
Sponsors
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University of Manchester
OTHER
Mayo Clinic
OTHER
Responsible Party
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Kenneth R. DeVault, M.D.
Principal Investigator
Principal Investigators
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Kenneth DeVault, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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15-002020
Identifier Type: -
Identifier Source: org_study_id