Interstitial Lung DiseaseNCT02136394
The Role of Gastroesophageal Reflux in Scleroderma Pulmonary Fibrosis
An observational study of Interstitial Lung Disease and Systemic Sclerosis, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Scarring of the lungs is common in patients with scleroderma and is one of the main causes of death. Patients with scleroderma very frequently have problems with their gullet (esophagus), the food pipe that leads into the stomach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Systemic Sclerosis, Gastroesophageal Reflux
- What is being tested?
- Gastro-esophageal reflux
- How many people
- 100 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2014to Apr 2017
- 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: Patients seen in the department of respiratory medicine or rheumatology of two teaching hospitals in London.
Who may be able to join
- Patients aged > 18 years
- Diagnosis of SSc (American College of Rheumatology criteria)
- Interstitial lung disease (>5% extent of ILD on HRCT)
- Only for bronchoscopy: presence of troublesome cough and/or GER symptoms and/or recurrent chest infections and/or asymmetry of ILD changes on CT
Who cannot join
- Significant communication difficulties
- Unable to perform reliable lung function tests
- Current smokers
- Only for bronchoscopy: FEV1 less than 1L or DLCO less than 30% of the predicted
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal free hospital
London, NW3 2PF
Christopher Denton, MD, 020 77940432, c.denton@ucl.ac.uk
Christopher Denton, MD
- Recruiting
Royal Brompton hospital
London, SW3 6NP
Elisabetta Renzoni, 02073528121, e.renzoni@imperial.ac.uk
Elisabetta Renzoni
About this study
Official title: Investigation Into the Role of Gastroesophageal Reflux in Pulmonary Fibrosis in Scleroderma
Scarring of the lungs is common in patients with scleroderma and is one of the main causes of death. Patients with scleroderma very frequently have problems with their gullet (esophagus), the food pipe that leads into the stomach.
Normally, a small circular muscle at the base of the esophagus opens to allow food to pass into the stomach and closes to keep the digestive fluids from flowing back up into the gullet. In patients with scleroderma, the muscle may become weak and no longer close properly. Gastroesophageal reflux (GER) is the medical term for reflux of stomach contents into the esophagus.
Our hypothesis is that small amounts of GER can move back up into the esophagus and get inhaled into the lungs, and may be one of the triggers for lung scarring. We propose to look for certain substances normally only found in the stomach in the "exhaled breath condensate" which is collected by breathing comfortably into a cooled cylinder, allowing the breath to condensate. In a smaller group of patients, we also plan to perform a bronchoalveolar lavage, a more widely studied test in which a small amount of fluid is introduced into a small part of the lungs through a fine tube, and then removed for examination, to evaluate whether the two tests provide similar measurements. We will also evaluate the correlation between these molecules and other tests, including lung function, and markers of lung scarring activity, and tests to look at how the esophagus is working so that we can get a clearer picture of how this affects patients' daily lives. Finally, we will be following up patients over time with lung function to see whether evidence of GER into the lungs is linked with a greater likelihood of worsening of lung scarring in the future.
- Being tested
- Gastro-esophageal reflux
- Medical subject headings
- Lung Diseases, Interstitial, Scleroderma, Systemic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastro-esophageal refluxOther
This is an observational study. The exposure is the gastro-esophageal reflux.
| Study group | Role | What they receive |
|---|---|---|
| Severe/moderate acid reflux | Not described Receives: Other: Gastro-esophageal reflux | |
| Mild/absent acid reflux | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of pepsin and pH in the Exhaled breath condensate (EBC)
Measured: Baseline
In a subgroup pf 40 patients, measurements of pepsin and bile salts in bronchoalveolar lavage (BAL)
Measured: Baseline
Serum KL-6
Serum KL-6 is a known marker of alveolar epithelial damage in SSc-ILD
Measured: Baseline
Measurements of pepsin and pH in the Exhaled breath condensate (EBC)
Measured: 12 months
Secondary outcomes (1)
Changes from baseline in longitudinal lung function assessment
Spirometry with total lung capacity, diffusing capacity for CO
Measured: Baseline, month 6, month 12, month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136394
- Sponsor's protocol ID
- 2013OE006B
- Status last verified
- Apr 2016
- First submitted
- 30 Dec 2013
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Role of Gastroesophageal Reflux in Pulmonary Fibrosis in Scleroderma
- ClinicalTrials.gov ID
- NCT02136394
- Acronym / sponsor ID
- 2013OE006B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 13 May 2014 (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.
Scarring of the lungs is common in patients with scleroderma and is one of the main causes of death. Patients with scleroderma very frequently have problems with their gullet (esophagus), the food pipe that leads into the stomach.
Normally, a small circular muscle at the base of the esophagus opens to allow food to pass into the stomach and closes to keep the digestive fluids from flowing back up into the gullet. In patients with scleroderma, the muscle may become weak and no longer close properly. Gastroesophageal reflux (GER) is the medical term for reflux of stomach contents into the esophagus.
Our hypothesis is that small amounts of GER can move back up into the esophagus and get inhaled into the lungs, and may be one of the triggers for lung scarring. We propose to look for certain substances normally only found in the stomach in the "exhaled breath condensate" which is collected by breathing comfortably into a cooled cylinder, allowing the breath to condensate. In a smaller group of patients, we also plan to perform a bronchoalveolar lavage, a more widely studied test in which a small amount of fluid is introduced into a small part of the lungs through a fine tube, and then removed for examination, to evaluate whether the two tests provide similar measurements. We will also evaluate the correlation between these molecules and other tests, including lung function, and markers of lung scarring activity, and tests to look at how the esophagus is working so that we can get a clearer picture of how this affects patients' daily lives. Finally, we will be following up patients over time with lung function to see whether evidence of GER into the lungs is linked with a greater likelihood of worsening of lung scarring in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe/moderate acid reflux | – | Other: Gastro-esophageal reflux |
| Mild/absent acid reflux | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in the department of respiratory medicine or rheumatology of two teaching hospitals in London.
Key inclusion criteria (4 listed)
- Patients aged > 18 years
- Diagnosis of SSc (American College of Rheumatology criteria)
- Interstitial lung disease (>5% extent of ILD on HRCT)
- Only for bronchoscopy: presence of troublesome cough and/or GER symptoms and/or recurrent chest infections and/or asymmetry of ILD changes on CT
Key exclusion criteria (4 listed)
- Significant communication difficulties
- Unable to perform reliable lung function tests
- Current smokers
- Only for bronchoscopy: FEV1 less than 1L or DLCO less than 30% of the predicted
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 |
|---|---|---|
| Gastro-esophageal refluxThis is an observational study. The exposure is the gastro-esophageal reflux. | Other | Severe/moderate acid reflux |
Primary outcome
Measurements of pepsin and pH in the Exhaled breath condensate (EBC)
Time frame: Baseline
In a subgroup pf 40 patients, measurements of pepsin and bile salts in bronchoalveolar lavage (BAL)
Time frame: Baseline
Serum KL-6
Time frame: Baseline
Serum KL-6 is a known marker of alveolar epithelial damage in SSc-ILD
Measurements of pepsin and pH in the Exhaled breath condensate (EBC)
Time frame: 12 months
1 secondary outcome
Changes from baseline in longitudinal lung function assessment
Time frame: Baseline, month 6, month 12, month 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Systemic Sclerosis, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites 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 4 inclusion and 4 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 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabetta Renzoni, MD (02073528121, e.renzoni@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of pepsin and pH in the Exhaled breath condensate (EBC) (time frame: Baseline). The study lists 4 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 7 Apr 2016.