CoughNCT00451841
Exhaled Breath Condensate pH in Patients With Cough Caused by Gastroesophageal Reflux
An observational study of Cough and Gastroesophageal Reflux, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Cough is the most common complaint for which patients seek medical attention in the United States, accounting for approximately 1 billion dollars in health care expenses annually. Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of all cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cough, Gastroesophageal Reflux
- What is being tested?
- RTube Exhaled Breath Condensate Collection System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jun 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients evaluated for cough in the Lung and Allergy Center of Umass Memorial Medical Center
Who may be able to join
- age > 18 years old
- able to speak and read English
- chronic cough
Who cannot join
- Cigarette smoking within the past 6 months, or greater than 10 pack year history of prior smoking
- Any self-reported or clinically diagnosed form of active lung disease, including asthma and emphysema
- Symptoms of persistent rhinitis within the past three months
- Dysphagia
- Symptoms of acute viral upper respiratory tract infection or sinusitis within one month of entry into the study
- Pregnancy - based on self report
- Abnormal chest radiograph
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Medical Center, University Campus
Worcester, Massachusetts, 01655
About this study
Cough is the most common complaint for which patients seek medical attention in the United States, accounting for approximately 1 billion dollars in health care expenses annually. Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of all cases. The majority of these patients with GERD-induced cough have no classic "heartburn" symptoms, so this important cause of cough can thus be difficult to detect.
Our hypothesis is that changes in exhaled breath condensate (EBC) pH can be used as a sensitive and non-invasive marker to identify subjects with cough caused by acid reflux.
Read the detailed description
Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of all cases, and majority of these patients with GERD-induced cough have no classic "heartburn" symptoms. This important cause of cough can thus be difficult to detect. Non-invasive radiologic tests for GERD such as barium swallow is imperfectly sensitive in subjects with GERD-induced cough. The 24 hour pH probe, which continuously monitors esophageal pH and can correlate cough events with reflux events, is considered to be the gold standard test. However, this test is expensive, invasive, and not universally available.
The goal of the current study is to compare simultaneous measurements of esophageal pH with exhaled breath condensate pH after cough episodes, in patients with symptomatic cough. The cause of cough will be determined by a standard protocol, which includes 24 hour pH probe studies, and assessment for asthma, upper airway causes and sinus disease, and medication effects. All subjects will undergo 24 hour pH monitoring. During this monitoring period, they press an event button on the pH recording device to indicate a cough episode. After six such events, they will immediately perform an EBC collection, and EBC pH will subsequently be analyzed. Differences between pH changes in the group with cough cause by GERD will be compared to pH measurements in the group with cough but no GERD, to determine the sensitivity and specificity of pH changes for discriminating between the two groups, and optimal threshold values for pH changes in EBC.
- Conditions
- Cough, Gastroesophageal Reflux
- Being tested
- RTube Exhaled Breath Condensate Collection System
- Keywords
- Cough, Gastroesophageal reflux, Exhaled breath condensate
- Medical subject headings
- Cough, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTube Exhaled Breath Condensate Collection SystemDevice
Subjects breath through the device to collect exhaled breath condensate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Chronic cough caused by GERD Receives: Device: RTube Exhaled Breath Condensate Collection System | |
| 2 | Chronic cough without GERD Receives: Device: RTube Exhaled Breath Condensate Collection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of esophageal PH changes
Determine the sensitivity of esophageal PH changes between the group with GERD and the group without GERD.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: IRB approval not renewed/approval lapsed. Prior status: insufficient enrollment; study suspended pending analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Krinzman, University of Massachusetts, Worcester
- Investigators
- Stephen Krinzman, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451841
- Sponsor's protocol ID
- H-12073
- Status last verified
- Jun 2018
- First submitted
- 22 Mar 2007
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Niimi A, Nguyen LT, Usmani O, Mann B, Chung KF. Reduced pH and chloride levels in exhaled breath condensate of patients with chronic cough. Thorax. 2004 Jul;59(7):608-12. doi: 10.1136/thx.2003.012906.
PubMed 15223872Hunt J. Exhaled breath condensate pH: reflecting acidification of the airway at all levels. Am J Respir Crit Care Med. 2006 Feb 15;173(4):366-7. doi: 10.1164/rccm.2512001. No abstract available.
PubMed 16467175Horvath I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jobsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48. doi: 10.1183/09031936.05.00029705.
PubMed 16135737
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Condensate pH in Patients With Cough Caused by Gastroesophageal Reflux
- ClinicalTrials.gov ID
- NCT00451841
- Acronym / sponsor ID
- H-12073
- Conditions
- Cough, Gastroesophageal Reflux
- Keywords
- Cough, Gastroesophageal reflux, Exhaled breath condensate
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IRB approval not renewed/approval lapsed. Prior status: insufficient enrollment; study suspended pending analysis
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Mar 2007 (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.
Cough is the most common complaint for which patients seek medical attention in the United States, accounting for approximately 1 billion dollars in health care expenses annually. Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of all cases. The majority of these patients with GERD-induced cough have no classic "heartburn" symptoms, so this important cause of cough can thus be difficult to detect.
Our hypothesis is that changes in exhaled breath condensate (EBC) pH can be used as a sensitive and non-invasive marker to identify subjects with cough caused by acid reflux.
Detailed description
Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of all cases, and majority of these patients with GERD-induced cough have no classic "heartburn" symptoms. This important cause of cough can thus be difficult to detect. Non-invasive radiologic tests for GERD such as barium swallow is imperfectly sensitive in subjects with GERD-induced cough. The 24 hour pH probe, which continuously monitors esophageal pH and can correlate cough events with reflux events, is considered to be the gold standard test. However, this test is expensive, invasive, and not universally available.
The goal of the current study is to compare simultaneous measurements of esophageal pH with exhaled breath condensate pH after cough episodes, in patients with symptomatic cough. The cause of cough will be determined by a standard protocol, which includes 24 hour pH probe studies, and assessment for asthma, upper airway causes and sinus disease, and medication effects. All subjects will undergo 24 hour pH monitoring. During this monitoring period, they press an event button on the pH recording device to indicate a cough episode. After six such events, they will immediately perform an EBC collection, and EBC pH will subsequently be analyzed. Differences between pH changes in the group with cough cause by GERD will be compared to pH measurements in the group with cough but no GERD, to determine the sensitivity and specificity of pH changes for discriminating between the two groups, and optimal threshold values for pH changes in EBC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: RTube Exhaled Breath Condensate Collection SystemChronic cough caused by GERD |
| 2 | – | Device: RTube Exhaled Breath Condensate Collection SystemChronic cough without GERD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients evaluated for cough in the Lung and Allergy Center of Umass Memorial Medical Center
Key inclusion criteria (3 listed)
- age > 18 years old
- able to speak and read English
- chronic cough
Key exclusion criteria (7 listed)
- Cigarette smoking within the past 6 months, or greater than 10 pack year history of prior smoking
- Any self-reported or clinically diagnosed form of active lung disease, including asthma and emphysema
- Symptoms of persistent rhinitis within the past three months
- Dysphagia
- Symptoms of acute viral upper respiratory tract infection or sinusitis within one month of entry into the study
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 |
|---|---|---|
| RTube Exhaled Breath Condensate Collection SystemSubjects breath through the device to collect exhaled breath condensate | Device | 1, 2 |
Primary outcome
Sensitivity of esophageal PH changes
Time frame: 24 hours
Determine the sensitivity of esophageal PH changes between the group with GERD and the group without GERD.
Results and safety
The study was stopped early (reason given: IRB approval not renewed/approval lapsed. Prior status: insufficient enrollment; study suspended pending analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 15223872Niimi A, Nguyen LT, Usmani O, Mann B, Chung KF. Reduced pH and chloride levels in exhaled breath condensate of patients with chronic cough. Thorax. 2004 Jul;59(7):608-12. doi: 10.1136/thx.2003.012906.
- Background: PubMed 16467175Hunt J. Exhaled breath condensate pH: reflecting acidification of the airway at all levels. Am J Respir Crit Care Med. 2006 Feb 15;173(4):366-7. doi: 10.1164/rccm.2512001. No abstract available.
- Background: PubMed 16135737Horvath I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jobsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48. doi: 10.1183/09031936.05.00029705.
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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.
Stephen Krinzman, MD principal investigator
University of Massachusetts, Worcester
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 Cough and Gastroesophageal Reflux, run by University of Massachusetts, Worcester 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 Jun 2018. 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?
The study was stopped early (reason given: IRB approval not renewed/approval lapsed. Prior status: insufficient enrollment; study suspended pending analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of esophageal PH changes (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00451841, which also lists 3 linked publications.
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 26 Jun 2018.