Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough

Scleroderma Lung Clinical Trial

Official title:

Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667042
• Other study ID #: 12-000304
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: January 7, 2016
• Start date: August 2012
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Scleroderma Lung
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway pepsin concentration	Cross-sectional comparison between airway pepsin level, cough frequency, FVC, DLCO, and CT fibrosis score	cross-sectional	No