Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT00330603

Conditions

Gastroesophageal Reflux

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Interventions

Serial exhaled breath collections

Study Details

Brief summary:

This study will seek to determine the amount of acids a person with a chronic cough that is suspected to be related to acid reflux breathes out after coughing. The study will also seek to determine if this measurement can predict the best treatment for the cough.

Subjects with a chronic cough which is suspected to be related to acid reflux for which their doctor has prescribed a proton pump inhibitor medication will be enrolled in this study.

Conditions

Gastroesophageal Reflux

Study ID

NCT00330603

Start date

Apr, 2006

Status verified date

Mar, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Outpatient
  • 5 years of age and older
  • Cough lasting a minimum of 3 weeks
  • Has been prescribed a proton pump inhibitor as a single therapeutic and diagnostic effort to control the cough

Exclusion Criteria:

  • Inability to perform serial exhaled breath condensate collections at home
  • Unwillingness to initiate proton pump inhibitor therapy as prescribed by physician
  • Other changes planned in therapy, such as initiating or discontinuing cough suppressant therapy, initiating or augmenting antibiotic therapy, initiating or augmenting anti-inflammatory therapy
  • Previous treatment of respiratory symptoms with proton pump inhibitor therapy
  • Current treatment with angiotensin converting enzyme inhibitor medication or H2 antagonists
  • Regular exposure to an environmental irritant

Study Design

Enrollment

99 participants

Anticipated

Interventions and Outcome Measures

Interventions

Serial exhaled breath collections

collect breath for 5 minutes on 8 occasions

Primary outcome measure

  • pH of cough samples [ Time Frame: 1 month ]
  • change in Leicester Cough Questionnaire (LCQ) total score [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

John Hunt, MD

434-243-9324jfh2m@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

John Hunt, MD

434-243-9916jfh2m@virginia.edu

Principal Investigator:

John Hunt, MD

More Information

Sponsor

University of Virginia

Last update posted

Mar 8, 2011

Last verified

Mar, 2011

Keywords

  • Cough
  • Gastroesophageal Reflux

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2011-03-08.