Esophageal Motility in Reflux Induced Cough

Cough Clinical Trial

Official title:

Chronic Cough and Reflux: Is Esophageal Motility the Key?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492126
• Other study ID #: 15-002020
• Status: Completed
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cough

Intervention

Other:
• Citric Acid
Subjects will undergo cough reflex sensitivity testing to citric acid.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	University of Manchester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with reflux related cough		24 hrs

External Links

•   Mayo Clinic Clinical Trials