Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough

NCT ID: NCT01667042

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-06-30

Brief Summary

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

Conditions

Scleroderma Lung

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Without Interstitial lung disease (ILD)

No interventions assigned to this group

With Interstitial lung disease (ILD)

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Augustine S. Lee

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Augustine Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

12-000304

Identifier Type: -

Identifier Source: org_study_id