Clinical trial NCT01667042: Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough
Official title: Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scleroderma Lung
Keywords: Scleroderma Lung
Gastroesophageal Reflux
Microaspiration
Cough
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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


Eligibility 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

Primary outcomes:
measure: Airway pepsin concentration
timeFrame: cross-sectional
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Augustine Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: