Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough


  • Study type

  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 12-000304
    NCT ID: NCT01667042
    Sponsor Protocol Number: 12-000304

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Augustine Lee, M.D.

Closed for enrollment


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