Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667042
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : January 8, 2016
Information provided by (Responsible Party):
Augustine S. Lee, Mayo Clinic

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

Condition or disease
Scleroderma Lung

Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough
Study Start Date : August 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2015

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

Primary Outcome Measures :
  1. Airway pepsin concentration [ Time Frame: cross-sectional ]
    Cross-sectional comparison between airway pepsin level, cough frequency, FVC, DLCO, and CT fibrosis score

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive adult patients seen at the Mayo Clinic in Florida with a confirmed diagnosis of systemic sclerosis (SSc) will be eligible.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01667042

United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Augustine Lee, M.D. Mayo Clinic

Responsible Party: Augustine S. Lee, M.D., Mayo Clinic Identifier: NCT01667042     History of Changes
Other Study ID Numbers: 12-000304
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016

Keywords provided by Augustine S. Lee, Mayo Clinic:
Scleroderma Lung
Gastroesophageal Reflux

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Connective Tissue Diseases
Skin Diseases