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Investigation Into the Role of Gastroesophageal Reflux in Pulmonary Fibrosis in Scleroderma
Sponsor study identifier
observational
100
1 country
2
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 30, 2013
Actual (reported)February 2014
Date type not reportedThis date has not been verified as actual or estimated.
May 13, 2014
Actual (reported)December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Measurements of pepsin and pH in the Exhaled breath condensate (EBC)
Baseline
In a subgroup pf 40 patients, measurements of pepsin and bile salts in bronchoalveolar lavage (BAL)
Baseline
Serum KL-6
Serum KL-6 is a known marker of alveolar epithelial damage in SSc-ILD
Baseline
Measurements of pepsin and pH in the Exhaled breath condensate (EBC)
12 months
Changes from baseline in longitudinal lung function assessment
Baseline, month 6, month 12, month 18
This is an observational study. The exposure is the gastro-esophageal reflux.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients seen in the department of respiratory medicine or rheumatology of two teaching hospitals in London.
Royal free hospital
London, NW3 2PF, United Kingdom
Royal Brompton hospital
London, SW3 6NP, United Kingdom
First Submitted
December 30, 2013
First Posted
May 13, 2014
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 7, 2016
Record last verified: 2016-04
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Source: ClinicalTrials.gov.
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