Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough


This is a mechanistic research study to evaluate the relationship between cough, reflux, and aspiration in patients with systemic sclerosis (scleroderma).

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: June 2014

Arms, Groups and Cohorts

  • Without Interstitial lung disease (ILD)
  • With Interstitial lung disease (ILD)

Clinical Trial Outcome Measures

Primary Measures

  • Airway pepsin concentration
    • Time Frame: cross-sectional
    • Cross-sectional comparison between airway pepsin level, cough frequency, FVC, DLCO, and CT fibrosis score

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients ≥ 18 years old. – Fulfilling the American College of Rheumatology criteria for SSc. – For ILD subgroup (n=6): – An upright chest-roentgenogram (chest x-ray) is abnormal and compatible with an interstitial lung disease. – HRCT of the chest confirms the presence of bilateral reticular, ground glass, and/or honeycomb abnormalities that is otherwise unexplained by an alternative process – The HRCT fibrosis score must be ≥ 7. – The total lung capacity (TLC, measured by body plethysmography) and/or the diffusing capacity of the lung for carbon monoxide (DLCO) is below the predicted normal. – The forced vital capacity (FVC) is reduced below the predicted normal. – The patient is symptomatic (i.e. dyspnea and/or a chronic cough) for more than 8 weeks that is otherwise unexplained by an alternative mechanism. – For No ILD subgroup (n=6): – No radiographic evidence of ILD on plain chest x-ray. – The HRCT fibrosis score, when performed) must be < 7 – The TLC and FVC are within their predicted normal. – The DLCO is within the predicted normal, except when reduced in isolation by pulmonary hypertension. Exclusion Criteria:

  • Active smoking within the 6 months. – Pneumonia or bronchitis in past 4 weeks. – Active acute illness such as uncontrolled heart failure, infection, or asthma. – Use of more than 3 liters per minute (LPM) of oxygen by nasal cannula at rest. – Coordinator, investigator, or clinician concerns on the patient's compliance, safety, or in ability to complete study requirements. – Morbid condition not expected to live more than 1 year. – Alternative cause or diagnosis for the patient's ILD besides SSc. – Pregnancy. – Obstructive lung disease with an FEV1 (forced expiratory volume in 1 second) to FVC ratio less than 0.7, nor radiographic evidence of emphysema on CT. – Planned therapeutic procedures involving the esophagus (e.g. dilation, surgery) prior to completion of study tests

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Augustine S. Lee, M.D. – Mayo Clinic
  • Overall Official(s)
    • Augustine Lee, M.D., Principal Investigator, Mayo Clinic

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