Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough
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?
- 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.
- 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.
- 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