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Effect of CPAP on Abnormal Gastroesophageal Reflux and Lung Inflammation in IPF

Primary Purpose

Idiopathic Pulmonary Fibrosis, Obstructive Sleep Apnea, Gastro Esophageal Reflux

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Airway Pressure
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring IPF, OSA, GERD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • confirmed diagnosis of IPF based on the 2018 IPF guidelines
  • high likelihood of OSA based on the STOP-BANG measure, with a score of 3 or greater
  • patients on nintedanib, or in whom nintedanib will be initiated prior to enrollment in the study
  • able to participated in 24hr pH monitoring
  • able to comply with CPAP treatment
  • able to provide written informed consent prior to any study procedures
  • willing to complete all study measurements and assessments in compliance with the protocol

Exclusion Criteria:

  • interstitial lung disease caused by conditions other than IPF
  • severe concomitant illness limiting life expectancy (< 1 year)
  • residual lung volume > or equal to 120% of predicted
  • obstructive lung disease: FEV1/FVC ratio < 0.70
  • current drug or alcohol dependence
  • patients who are unable to tolerate nintedanib
  • patients who are unable to use CPAP or are unwilling to participate in the 24 hr pH probe placement
  • patients who were diagnosed with recent IPF exacerbation within 4 weeks of enrollment (may be rescheduled for enrollment once recovered)
  • patients who have had prior nasal surgery or trauma that would make pH probe placement difficult
  • patients on anticoagulation (aspirin is not an exclusion)

Sites / Locations

  • University of ArizonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CPAP

No CPAP

Arm Description

Subjects randomized to the treatment arm, will receive continuous positive airway pressure (CPAP) while sleeping via an autoPAP device for 4-8 weeks.

Subjects assigned to the no CPAP group will not have any intervention for a 4-8 week period.

Outcomes

Primary Outcome Measures

Composite Biomarker Score
The primary outcome will be a composite value that is a weighted average of z-scores of the biomarkers MMP1, MMP7, IL-8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker. MMP1, MMP7, IL-8, KL-6, and CXCL13 will be measured using enzyme linked immunosorbent assays (ELISA) for these analytes. (Z-score is a unitless number, as is the weighted average.)

Secondary Outcome Measures

Biomarker of Lung Inflammation: KL-6
The value of KL-6 measured by ELISA in U/ml.
Biomarker of Lung Inflammation: MMP1
The value of MMP1 measured by ELISA in ng/ml.
Biomarker of Lung Inflammation: MMP7
The value of MMP7 measured by ELISA in ng/ml.
Biomarker of Lung Inflammation: IL-8
The value of IL-8 measured by ELISA in pg/ml.
Biomarker of Lung Inflammation: CXCL13
The value of CXCL-13 measured by ELISA in pg/ml.
Esophageal pH During Sleep
Total sleep time (in minutes) with pH less than 4.
24hr-Esophageal pH
Total time (minutes in 24hr period) with pH less than 4.
FVC change
FVC change in percentage of predicted values over 6 months (baseline to 6 months).
Composite Biomarker Score at Six Months
Weighted average of z-scores of the biomarkers MMP1, MMP7, IL8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker at six months. (Z-score is a unitless number, as is the weighted average.)

Full Information

First Posted
February 21, 2022
Last Updated
April 24, 2023
Sponsor
University of Arizona
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05359965
Brief Title
Effect of CPAP on Abnormal Gastroesophageal Reflux and Lung Inflammation in IPF
Official Title
Effect of Continuous Positive Airway Pressure (CPAP) on Abnormal Gastroesophageal Reflux and Lung Inflammation in Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the effect of CPAP therapy on esophageal pH and lung inflammation in patients with idiopathic pulmonary fibrosis (IPF) and sleep apnea.
Detailed Description
Participants in this study will have an overnight sleep study done while wearing a 24 hour pH monitor in the esophagus. If the participant has sleep apnea, he or she will be randomly assigned to receive either CPAP treatment or no CPAP treatment. After 4-8 weeks, the participant will have another overnight sleep study with 24 hour pH monitoring. Blood will also be collected at both time points and again after 6 months to measure biomarkers that are related to lung inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Obstructive Sleep Apnea, Gastro Esophageal Reflux
Keywords
IPF, OSA, GERD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be assigned to treatment groups using a 1:1 randomized block design via the randomization module in REDCap. The PI and study coordinator will be blinded to next assignment.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Study investigators and care providers will be blinded and not involved in any CPAP or no CPAP related set-up, instruction, or device troubleshooting during the course the treatment phase. Lab personnel performing biomarker analysis will only have access to subject study ID and not treatment group assignments.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP
Arm Type
Experimental
Arm Description
Subjects randomized to the treatment arm, will receive continuous positive airway pressure (CPAP) while sleeping via an autoPAP device for 4-8 weeks.
Arm Title
No CPAP
Arm Type
No Intervention
Arm Description
Subjects assigned to the no CPAP group will not have any intervention for a 4-8 week period.
Intervention Type
Device
Intervention Name(s)
Positive Airway Pressure
Intervention Description
Gentle and steady pressure (with or without supplemental oxygen) delivered to the airways of the lungs while subjects are sleeping.
Primary Outcome Measure Information:
Title
Composite Biomarker Score
Description
The primary outcome will be a composite value that is a weighted average of z-scores of the biomarkers MMP1, MMP7, IL-8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker. MMP1, MMP7, IL-8, KL-6, and CXCL13 will be measured using enzyme linked immunosorbent assays (ELISA) for these analytes. (Z-score is a unitless number, as is the weighted average.)
Time Frame
4-8 weeks
Secondary Outcome Measure Information:
Title
Biomarker of Lung Inflammation: KL-6
Description
The value of KL-6 measured by ELISA in U/ml.
Time Frame
4-8 weeks
Title
Biomarker of Lung Inflammation: MMP1
Description
The value of MMP1 measured by ELISA in ng/ml.
Time Frame
4-8 weeks
Title
Biomarker of Lung Inflammation: MMP7
Description
The value of MMP7 measured by ELISA in ng/ml.
Time Frame
4-8 weeks
Title
Biomarker of Lung Inflammation: IL-8
Description
The value of IL-8 measured by ELISA in pg/ml.
Time Frame
4-8 weeks
Title
Biomarker of Lung Inflammation: CXCL13
Description
The value of CXCL-13 measured by ELISA in pg/ml.
Time Frame
4-8 weeks
Title
Esophageal pH During Sleep
Description
Total sleep time (in minutes) with pH less than 4.
Time Frame
4-8 weeks
Title
24hr-Esophageal pH
Description
Total time (minutes in 24hr period) with pH less than 4.
Time Frame
4-8 weeks
Title
FVC change
Description
FVC change in percentage of predicted values over 6 months (baseline to 6 months).
Time Frame
6 months
Title
Composite Biomarker Score at Six Months
Description
Weighted average of z-scores of the biomarkers MMP1, MMP7, IL8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker at six months. (Z-score is a unitless number, as is the weighted average.)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: confirmed diagnosis of IPF based on the 2018 IPF guidelines high likelihood of OSA based on the STOP-BANG measure, with a score of 3 or greater patients on nintedanib, or in whom nintedanib will be initiated prior to enrollment in the study able to participated in 24hr pH monitoring able to comply with CPAP treatment able to provide written informed consent prior to any study procedures willing to complete all study measurements and assessments in compliance with the protocol Exclusion Criteria: interstitial lung disease caused by conditions other than IPF severe concomitant illness limiting life expectancy (< 1 year) residual lung volume > or equal to 120% of predicted obstructive lung disease: FEV1/FVC ratio < 0.70 current drug or alcohol dependence patients who are unable to tolerate nintedanib patients who are unable to use CPAP or are unwilling to participate in the 24 hr pH probe placement patients who were diagnosed with recent IPF exacerbation within 4 weeks of enrollment (may be rescheduled for enrollment once recovered) patients who have had prior nasal surgery or trauma that would make pH probe placement difficult patients on anticoagulation (aspirin is not an exclusion)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin Chaudhary, MD
Phone
520-621-4368
Email
sachin@deptofmed.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sairam Parthasarathy, MD
Phone
520-626-8309
Email
sparthasarathy@deptofmed.arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sachin Chaudhary, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Erickson, RN
Phone
520-626-5287
Email
herickso@email.arizona.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of CPAP on Abnormal Gastroesophageal Reflux and Lung Inflammation in IPF

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