The Role of Gastroesophageal Reflux in Scleroderma Pulmonary Fibrosis

Systemic Sclerosis Clinical Trial

Official title:

Investigation Into the Role of Gastroesophageal Reflux in Pulmonary Fibrosis in Scleroderma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02136394
• Other study ID #: 2013OE006B
• Status: Recruiting
• Phase: N/A
• First received: December 30, 2013
• Last updated: April 6, 2016
• Start date: February 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2016
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: Elisabetta Renzoni, MD
• Phone: 02073528121
• Email: e.renzoni[@]imperial.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Systemic Sclerosis

Intervention

Other:
• Gastro-esophageal reflux
This is an observational study. The exposure is the gastro-esophageal reflux.

Locations

Country	Name	City	State
United Kingdom	Royal Brompton hospital	London
United Kingdom	Royal free hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of pepsin and pH in the Exhaled breath condensate (EBC)		Baseline	No
Primary	In a subgroup pf 40 patients, measurements of pepsin and bile salts in bronchoalveolar lavage (BAL)		Baseline	No
Primary	Serum KL-6	Serum KL-6 is a known marker of alveolar epithelial damage in SSc-ILD	Baseline	No
Primary	Measurements of pepsin and pH in the Exhaled breath condensate (EBC)		12 months	No
Secondary	Changes from baseline in longitudinal lung function assessment	Spirometry with total lung capacity, diffusing capacity for CO	Baseline, month 6, month 12, month 18	No