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OpenTrials
Completed

NCT Number: NCT02492126

Esophageal Motility in Reflux Induced Cough

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Citric Acid

Other

Subjects will undergo cough reflex sensitivity testing to citric acid.

Primary outcomes

  1. Percentage of subjects with reflux related cough

    Time frame: 24 hrs

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • University of Manchester

Registry information

Official study title

Chronic Cough and Reflux: Is Esophageal Motility the Key?

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 8, 2015
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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