Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough
| Status: | Completed |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2012 |
| End Date: | June 2015 |
This is a mechanistic research study to evaluate the relationship between cough, reflux, and
aspiration in patients with systemic sclerosis (scleroderma).
aspiration in patients with systemic sclerosis (scleroderma).
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
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