CoughNCT03851393
Validation of Peptest™ for the Detection of Reflux in Cough
A study testing Induction of cough with inhaled citric acid, Peptest™ analysis of saliva pepsin and Peptest™ in people with Cough, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Chronic cough is a common presenting problem which has a significant impact on quality of life. Gastro-oesophageal reflux (GOR) is a common cause of chronic cough and reflux of stomach contents into the airways has been implicated in the pathogenesis of a number of respiratory diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- Induction of cough with inhaled citric acid, Peptest™ analysis of saliva pepsin and Peptest™
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Oct 2014
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A negative score for airway reflux (HARQ score <13).
- Provision of informed consent.
Who cannot join
- Participants with a positive score for airway reflux (HARQ score >13).
- Chronic respiratory disease.
- Acute gastro-respiratory illness at the time of the study.
- Participants who will be physically unable to undergo sputum collection or cough induction.
- Those who are unwilling to undergo cough challenge and induction of cough.
- Smoking or consumption of food, caffeinated or carbonated beverages for 30 minutes prior to sample collection.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull Clinical Trials Unit, Respiratory academic department
Cottingham, Yorkshire, HU16 5JQ
About this study
Official title: Validation of Peptest™ for the Detection of Reflux in Cough; Induction of Cough in Healthy Volunteers
Chronic cough is a common presenting problem which has a significant impact on quality of life. Gastro-oesophageal reflux (GOR) is a common cause of chronic cough and reflux of stomach contents into the airways has been implicated in the pathogenesis of a number of respiratory diseases. Clinical history in patients with suspected reflux can aid in the diagnosis but traditional investigations for GOR including 24hr oesophageal pH monitoring or endoscopy are not reliable diagnostic tools since the reflux may be non acidic.
The detection of pepsin in the sputum, saliva or bronchial biopsy has been found to be an accurate marker of reflux into the airways. Pepsin is solely produced by parietal cells in the stomach. The presence of pepsin in the upper airways therefore indicates reflux. Studies have demonstrated that pepsin was frequently found in laryngeal biopsies and sputum of patients with signs and symptoms of airways reflux and that Nissen fundoplication resulted in a decrease in pepsin detection alongside an improvement in symptoms. The Peptest™ lateral flow device has been shown to be effective in the detection of pepsin in sputum and saliva of patients with chronic cough and gastro-oesophageal reflux. The investigators have detected pepsin in expectorated saliva during episodes of cough, apparently supporting a diagnosis of airways reflux. Critics, however, have suggested that the act coughing itself is responsible for the reflux.
This study aims to identify if cough induced by inhaled citric acid in healthy adult volunteers leads to detectable pepsin in expectorated saliva.
- Conditions
- Cough
- Being tested
- Induction of cough with inhaled citric acid, Peptest™ analysis of saliva pepsin, Peptest™
- Keywords
- Cough, Reflux, Pepsin, Peptest
- 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.
Induction of cough with inhaled citric acidOther
perform artificially induced cough by inhalation of citric acid at various strengths
Peptest™ analysis of saliva pepsinProcedure or surgery
collect patient saliva for analysis of pepsin levels
Peptest™Diagnostic test
The Peptest™ lateral flow device
| Study group | Role | What they receive |
|---|---|---|
| Peptest™ analysis of saliva pepsin | Experimental | Induction of cough with inhaled citric acid and measurement of saliva pepsin following citric acid cough challenge using the peptest lateral device Receives: Other: Induction of cough with inhaled citric acid; Procedure: Peptest™ analysis of saliva pepsin; Diagnostic Test: Peptest™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of pepsin in saliva following a citric acid cough challenge
detecting the levels of pepsin in saliva following Citric acid induced cough
Measured: 3 months
Secondary outcomes (1)
normal range of saliva pepsin
record normal range of saliva pepsin following citric acid cough challenge
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alyn Morice, MD, FRCP, Principal investigator, Hull University Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851393
- Sponsor's protocol ID
- Acadmed130514
- Status last verified
- Jul 2019
- First submitted
- 15 May 2014
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Peptest™ for the Detection of Reflux in Cough; Induction of Cough in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03851393
- Acronym / sponsor ID
- Acadmed130514
- Conditions
- Cough
- Keywords
- Cough, Reflux, Pepsin, Peptest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Feb 2019 (actual)
- 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.
Chronic cough is a common presenting problem which has a significant impact on quality of life. Gastro-oesophageal reflux (GOR) is a common cause of chronic cough and reflux of stomach contents into the airways has been implicated in the pathogenesis of a number of respiratory diseases. Clinical history in patients with suspected reflux can aid in the diagnosis but traditional investigations for GOR including 24hr oesophageal pH monitoring or endoscopy are not reliable diagnostic tools since the reflux may be non acidic.
The detection of pepsin in the sputum, saliva or bronchial biopsy has been found to be an accurate marker of reflux into the airways. Pepsin is solely produced by parietal cells in the stomach. The presence of pepsin in the upper airways therefore indicates reflux. Studies have demonstrated that pepsin was frequently found in laryngeal biopsies and sputum of patients with signs and symptoms of airways reflux and that Nissen fundoplication resulted in a decrease in pepsin detection alongside an improvement in symptoms. The Peptest™ lateral flow device has been shown to be effective in the detection of pepsin in sputum and saliva of patients with chronic cough and gastro-oesophageal reflux. The investigators have detected pepsin in expectorated saliva during episodes of cough, apparently supporting a diagnosis of airways reflux. Critics, however, have suggested that the act coughing itself is responsible for the reflux.
This study aims to identify if cough induced by inhaled citric acid in healthy adult volunteers leads to detectable pepsin in expectorated saliva.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peptest™ analysis of saliva pepsin | Experimental | Other: Induction of cough with inhaled citric acid, Procedure: Peptest™ analysis of saliva pepsin, Diagnostic Test: Peptest™Induction of cough with inhaled citric acid and measurement of saliva pepsin following citric acid cough challenge using the peptest lateral device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A negative score for airway reflux (HARQ score <13).
- Provision of informed consent.
Key exclusion criteria (6 listed)
- Participants with a positive score for airway reflux (HARQ score >13).
- Chronic respiratory disease.
- Acute gastro-respiratory illness at the time of the study.
- Participants who will be physically unable to undergo sputum collection or cough induction.
- Those who are unwilling to undergo cough challenge and induction of cough.
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 |
|---|---|---|
| Induction of cough with inhaled citric acidperform artificially induced cough by inhalation of citric acid at various strengths | Other | Peptest™ analysis of saliva pepsin |
| Peptest™ analysis of saliva pepsincollect patient saliva for analysis of pepsin levels | Procedure or surgery | Peptest™ analysis of saliva pepsin |
| Peptest™The Peptest™ lateral flow device | Diagnostic test | Peptest™ analysis of saliva pepsin |
Primary outcome
level of pepsin in saliva following a citric acid cough challenge
Time frame: 3 months
detecting the levels of pepsin in saliva following Citric acid induced cough
1 secondary outcome
normal range of saliva pepsin
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Publication LinkLink provided by the sponsor.
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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.
Alyn Morice, MD, FRCP principal investigator
Hull University Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction of cough with inhaled citric acid, Peptest™ analysis of saliva pepsin and Peptest™ in people with Cough, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 2 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: finished, as of the sponsor's last update on 15 Jul 2019. 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 Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
level of pepsin in saliva following a citric acid cough challenge (time frame: 3 months). 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 15 Jul 2019.