Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough (NCT01667042) | Clinical Trial Compass
CompletedNot Applicable
Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough
United States7 participantsStarted 2012-08
Plain-language summary
This is a mechanistic research study to evaluate the relationship between cough, reflux, and aspiration in patients with systemic sclerosis (scleroderma).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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'…