Serial Exhaled Breath pH Monitoring

March 4, 2011 updated by: University of Virginia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Acid reflux has been considered to be a key contributor to cough, particularly in patients with obstructive lung diseases. However, diagnosis has relied upon either responsiveness to high dose twice daily administration of proton pump inhibitor therapy or by 24 hour esophageal pH probes. This study is designed to provide information for the development of a clinically useful diagnostic (exhaled breath condensate pH) to identify the contribution of acid reflux to cough.

Exhaled breath condensate (EBC) pH has been well documented to reflect airway acidification. Acid reflux to the level of the hypopharynx, which is a key common trigger of acid reflux induced cough, acidifies the airway sufficiently to be identified with EBC pH assays. The association of low EBC pH with an immediately preceding cough strongly suggests an association of the cough with an airway acid event, and even if the acidity is not prolonged, acid reflux becomes highly suspect.

This study will examine the ability of EBC pH measurements to prognose the likelihood of a positive response to acid blockade with proton pump inhibitor therapy in subjects with chronic cough.

Study Type

Observational

Enrollment (Anticipated)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • John Hunt, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with chronic cough for whom their doctor is planning to begin an empiric trial of proton pump inhibitor as a diagnostic trial of therapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pH of cough samples
Time Frame: 1 month
1 month
change in Leicester Cough Questionnaire (LCQ) total score
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
proton pump inhibitor dosing
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: John Hunt, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

May 26, 2006

First Submitted That Met QC Criteria

May 26, 2006

First Posted (Estimate)

May 29, 2006

Study Record Updates

Last Update Posted (Estimate)

March 8, 2011

Last Update Submitted That Met QC Criteria

March 4, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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