Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Mayo Clinic
Information provided by (Responsible Party):
Augustine S. Lee, Mayo Clinic Identifier:
First received: August 14, 2012
Last updated: September 8, 2014
Last verified: September 2014

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

Scleroderma Lung

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Airway pepsin concentration [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
    Cross-sectional comparison between airway pepsin level, cough frequency, FVC, DLCO, and CT fibrosis score

Estimated Enrollment: 12
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Without Interstitial lung disease (ILD)
With Interstitial lung disease (ILD)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01667042

Contact: Frances K Cayer 904-953-7778

United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Frances K Cayer    904-953-7778   
Principal Investigator: Augustine Lee, M.D.         
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Augustine Lee, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Augustine S. Lee, M.D., Mayo Clinic Identifier: NCT01667042     History of Changes
Other Study ID Numbers: 12-000304
Study First Received: August 14, 2012
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Scleroderma Lung
Gastroesophageal Reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Scleroderma, Diffuse
Scleroderma, Systemic
Connective Tissue Diseases
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Skin Diseases processed this record on March 26, 2015