Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Augustine S. Lee, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01667042
First received: August 14, 2012
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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


Condition
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: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Without Interstitial lung disease (ILD)
With Interstitial lung disease (ILD)

  Eligibility

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.

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
  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 ClinicalTrials.gov identifier: NCT01667042

Contacts
Contact: Kellie Ruday 904-953-7766 ruday.kellie@mayo.edu

Locations
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kellie Ruday    904-953-7766    ruday.kellie@mayo.edu   
Principal Investigator: Augustine Lee, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Augustine Lee, M.D. Mayo Clinic
  More Information

No publications provided

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

Keywords provided by Mayo Clinic:
Scleroderma Lung
Gastroesophageal Reflux
Microaspiration
Cough

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

ClinicalTrials.gov processed this record on July 22, 2014