Gastroesophageal RefluxNCT00330603
Serial Exhaled Breath pH Monitoring
An observational study of Gastroesophageal Reflux, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Serial exhaled breath collections
- Type of treatment
- Surgery or procedure
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
John Hunt, MD, 434-243-9916, jfh2m@virginia.edu
John Hunt, MD
About this study
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Serial exhaled breath collections
- Keywords
- Cough, Gastroesophageal Reflux
- Medical subject headings
- Gastroesophageal Reflux, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial exhaled breath collectionsProcedure or surgery
collect breath for 5 minutes on 8 occasions
What is being measured
The primary outcome is the main question the study is designed to answer.
pH of cough samples
Measured: 1 month
change in Leicester Cough Questionnaire (LCQ) total score
Measured: 1 month
Secondary outcomes (1)
proton pump inhibitor dosing
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- John Hunt, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330603
- Sponsor's protocol ID
- 12302
- Status last verified
- Mar 2011
- First submitted
- 26 May 2006
- Last updated
- 8 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Exhaled Breath pH Monitoring
- ClinicalTrials.gov ID
- NCT00330603
- Acronym / sponsor ID
- 12302
- Conditions
- Gastroesophageal Reflux
- Keywords
- Cough, Gastroesophageal Reflux
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 29 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial exhaled breath collectionscollect breath for 5 minutes on 8 occasions | Procedure or surgery | – |
Primary outcome
pH of cough samples
Time frame: 1 month
change in Leicester Cough Questionnaire (LCQ) total score
Time frame: 1 month
1 secondary outcome
proton pump inhibitor dosing
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hunt, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Hunt, MD (434-243-9324, jfh2m@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pH of cough samples (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011.