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

Obstructive Sleep Apnea Clinical Trial

Official title:

Effect of Continuous Positive Airway Pressure (CPAP) on Abnormal Gastroesophageal Reflux and Lung Inflammation in Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05359965
• Other study ID #: IIS2018-10747
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2023
• Source: University of Arizona
• Contact: Sachin Chaudhary, MD
• Phone: 520-621-4368
• Email: sachin[@]deptofmed.arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fibrosis
• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Idiopathic Pulmonary Fibrosis
• Inflammation
• Obstructive Sleep Apnea
• Pneumonia
• Pulmonary Fibrosis
• Sleep Apnea, Obstructive

Intervention

Device:
• Positive Airway Pressure
Gentle and steady pressure (with or without supplemental oxygen) delivered to the airways of the lungs while subjects are sleeping.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biomarker of Lung Inflammation: KL-6	The value of KL-6 measured by ELISA in U/ml.	4-8 weeks
Secondary	Biomarker of Lung Inflammation: MMP1	The value of MMP1 measured by ELISA in ng/ml.	4-8 weeks
Secondary	Biomarker of Lung Inflammation: MMP7	The value of MMP7 measured by ELISA in ng/ml.	4-8 weeks
Secondary	Biomarker of Lung Inflammation: IL-8	The value of IL-8 measured by ELISA in pg/ml.	4-8 weeks
Secondary	Biomarker of Lung Inflammation: CXCL13	The value of CXCL-13 measured by ELISA in pg/ml.	4-8 weeks
Secondary	Esophageal pH During Sleep	Total sleep time (in minutes) with pH less than 4.	4-8 weeks
Secondary	24hr-Esophageal pH	Total time (minutes in 24hr period) with pH less than 4.	4-8 weeks
Secondary	FVC change	FVC change in percentage of predicted values over 6 months (baseline to 6 months).	6 months
Secondary	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.)	6 months