Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough

Location:

Jacksonville, Fla.

Trial status:
Open for Enrollment
Why is this study being done?

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

Who is eligible to participate?

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

Last updated:
1/8/2014
NCT ID:
NCT01667042
IRB Number:
12-000304