Clinical trial NCT05359965: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Obstructive Sleep Apnea
Gastro Esophageal Reflux
Keywords: IPF
OSA
GERD
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2022-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Composite Biomarker Score
timeFrame: 4-8 weeks
Secondary outcomes:
measure: Biomarker of Lung Inflammation: KL-6
timeFrame: 4-8 weeks
measure: Biomarker of Lung Inflammation: MMP1
timeFrame: 4-8 weeks
measure: Biomarker of Lung Inflammation: MMP7
timeFrame: 4-8 weeks
measure: Biomarker of Lung Inflammation: IL-8
timeFrame: 4-8 weeks
measure: Biomarker of Lung Inflammation: CXCL13
timeFrame: 4-8 weeks
measure: Esophageal pH During Sleep
timeFrame: 4-8 weeks
measure: 24hr-Esophageal pH
timeFrame: 4-8 weeks
measure: FVC change
timeFrame: 6 months
measure: Composite Biomarker Score at Six Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Sachin Chaudhary, MD
role: PRINCIPAL_INVESTIGATOR
References: