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Esophageal Motility in Reflux Induced Cough

Chronic Cough and Reflux: Is Esophageal Motility the Key?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02492126
Enrollment
87
Registered
2015-07-08
Start date
2016-01-31
Completion date
2017-06-30
Last updated
2020-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

Keywords

Chronic Cough, Gastroesophageal Reflux, Esophageal Motility, Cough Sensitivity

Brief 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.

Interventions

Subjects will undergo cough reflex sensitivity testing to citric acid.

Sponsors

University of Manchester
CollaboratorOTHER
Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Adult patients (ages 18-75 years old) 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

1. Actively smoke in the preceding 6 months. 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

Design outcomes

Primary

MeasureTime frame
Percentage of subjects with reflux related cough24 hrs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026