Scleroderma Lung: Role of Gastroesophageal Reflux, Microa... | NCT01667042

Studies
Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough

NCT01667042

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jan 8, 2016Estimated

Enrollment

7Actual

Phase

Not provided

Conditions

Scleroderma Lung

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2015Actual

First Submitted Date

Aug 14, 2012

First Submission Date that Met QC Criteria

Aug 14, 2012

First Posted Date

Aug 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2016

Last Update Posted Date

Jan 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Measure	Description	Time Frame
Airway pepsin concentration	Cross-sectional comparison between airway pepsin level, cough frequency, FVC, DLCO, and CT fibrosis score	cross-sectional

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All consecutive adult patients seen at the Mayo Clinic in Florida with a confirmed diagnosis of systemic sclerosis (SSc) will be eligible.

Sampling Method

Probability Sample

Label	Type	Description	Intervention Names
Without Interstitial lung disease (ILD)
With Interstitial lung disease (ILD)

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D005764	Gastroesophageal Reflux
D003371	Cough