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

NCT05359965 | Terminated DMC FDA Device

• 1 other identifier: IIS2018-10747
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis; Obstructive Sleep Apnea; Gastro Esophageal Reflux

Keywords

IPF; OSA; GERD

Outcome Measures

Primary Outcomes (1)

• 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.)

  4-8 weeks

Secondary Outcomes (9)

• Biomarker of Lung Inflammation: KL-6

  4-8 weeks

• Biomarker of Lung Inflammation: MMP1

  4-8 weeks

• Biomarker of Lung Inflammation: MMP7

  4-8 weeks

• Biomarker of Lung Inflammation: IL-8

  4-8 weeks

• Biomarker of Lung Inflammation: CXCL13

  4-8 weeks

Study Arms (2)

CPAP

EXPERIMENTAL

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

Device: Positive Airway Pressure

No CPAP

NO INTERVENTION

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

Interventions

Positive Airway Pressure DEVICE

Gentle and steady pressure (with or without supplemental oxygen) delivered to the airways of the lungs while subjects are sleeping.

CPAP

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Sleep Apnea, Obstructive; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Sachin Chaudhary, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: May 4, 2022
• Study Start: October 1, 2019
• Primary Completion: March 26, 2024
• Study Completion: February 11, 2025
• Last Updated: March 9, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)