Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia

NCT07512687 | Recruiting

• 2 other identifiers: STUDY0001017K12TR005295
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Fibrotic forms of interstitial lung disease (ILD) and chronic obstructive pulmonary disease (COPD) are chronic lung disease which often affect how well oxygen can get from the lungs into the blood. Low blood oxygen levels often leads to shortness of breath which can affect patients' activity levels and quality-of-life. Many people with fibrotic ILD and COPD only have low oxygen levels when they are walking or exercising. Oxygen that is only used for walking or exercise is called ambulatory oxygen therapy (AOT). Laboratory studies suggest that AOT improves shortness of breath and exercise ability. However, real-world studies of AOT have not shown similar results. AOT can be given to patients through different types of equipment, most commonly oxygen tanks or portable oxygen concentrators (POCs). While previous studies have suggested that AOT does not significantly improve patients' breathing or activity in the real-world, these studies most often gave all participants the same amount of oxygen with the same device. However, patients with ILD and COPD often have very different oxygen needs during exercise, and POCs and oxygen tanks are very different in how oxygen is administered. This trial will test the feasibility of a study to determine whether real-world activity, symptoms, and quality-of-life are different with the use of different oxygen equipment when oxygen therapy has been adjusted to meet each participants' oxygen needs. A total of 24 participants (12 with fibrotic ILD and 12 with COPD) who only have low oxygen levels with activity will be randomly assigned to 2-week periods using either no oxygen therapy or oxygen delivered by oxygen tanks or POC. This trial will provide preliminary data to support a larger clinical trial to further test how different AOT equipment titrated to meet individual patients' needs may affect real-world outcomes in people with ILD and COPD.

Conditions

Interstitial Lung Disease; Chronic Obstructive Pulmonary Disease; Hypoxemia

Keywords

Ambulatory Oxygen Therapy; Portable Oxygen Concentrator; Exertional Hypoxemia; 6-Minute Walk Test; Real-World Activity

Outcome Measures

Primary Outcomes (1)

• Steps Per Day

  The primary outcome is a change in number of steps per day between each AOT device (POC and D-tanks) and compared to no oxygen therapy. Steps per day will be measured by ActiGraph LEAP, a wrist-worn device FDA-cleared for measuring activity. Participants will be instructed to wear this device during all waking hours.

  Daily steps during each 2-week intervention (POC, D-Tank, no oxygen therapy).

Secondary Outcomes (9)

• Mean Daily Oxygen Saturation (SpO2)

  Daily oxygen saturation averaged over 2-weeks for each intervention

• Time Spent With Oxygen Saturation (SpO2) Less Than 89%

  Oxygen saturation measured continuously during activity for each 2-week intervention

• Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score

  Baseline and at end of each 2-week intervention through study completion

• Change in Kings Brief Interstitial Lung Disease (K-BILD) Score

  Baseline and at end of each 2-week intervention through study completion

• Change in COPD Assessment Test (CAT) Score

  Baseline and at end of each 2-week intervention through study completion

Study Arms (2)

Fibrotic Interstitial Lung Disease

ACTIVE COMPARATOR

Participants with a pulmonologist-diagnosed fibrotic interstitial lung disease (idiopathic pulmonary fibrosis or other interstitial lung disease with fibrotic changes on chest imaging) who are ambulatory outside of home and who demonstrate isolated exertional hypoxemia on a 6-minute walk test.

Device: Portable Oxygen Concentrator; Device: Portable compressed oxygen D-tanks; Other: No ambulatory oxygen therapy

Chronic obstructive pulmonary disease

ACTIVE COMPARATOR

Participants with chronic obstructive pulmonary disease (COPD) with fixed airway obstruction less than 70% predicted who are ambulatory outside of the home and who demonstrate isolated exertional hypoxemia on a 6-minute walk test.

Device: Portable Oxygen Concentrator; Device: Portable compressed oxygen D-tanks; Other: No ambulatory oxygen therapy

Interventions

Portable Oxygen Concentrator DEVICE

Inogen Rove 6 portable oxygen concentrator will be used. This is a device which provides oxygen via demand pulse flow where a bolus of oxygen is delivered whenever the participant initiates a breath. Oxygen settings range from 1 to 6. Each setting has a fixed volume of oxygen delivered per minute with higher amounts delivered at higher settings. The actual amount of oxygen delivered each breath depends on a participant's respiratory rate. The device is battery powered and rechargeable. The battery can last over 6 hours on a setting of 1 with lower battery life at higher settings. The device weighs 4.8 pounds. The device stores data on device use, distribution of flow settings, device state (off, power up, active use), and battery capacity.

Chronic obstructive pulmonary disease; Fibrotic Interstitial Lung Disease

Portable compressed oxygen D-tanks DEVICE

Portable compressed oxygen tanks will be used, specifically D-tanks. D-tanks deliver oxygen at a continuous flow rate. Each D-tank tank holds approximately 404-425 liters of oxygen. When empty, a tank weighs approximately 8 pounds. Duration of tank use is dependent on flow rate with higher flow rates resulting in faster depletion.

Chronic obstructive pulmonary disease; Fibrotic Interstitial Lung Disease

No ambulatory oxygen therapy OTHER

No ambulatory oxygen therapy will be provided.

Chronic obstructive pulmonary disease; Fibrotic Interstitial Lung Disease

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>= 18 years old and \<= 85 years old with fibrotic ILD or COPD able to provide informed consent
• Fibrotic ILD includes idiopathic pulmonary fibrosis, sarcoidosis, or other ILD with fibrotic changes on lung imaging (reticulations, honeycombing, traction bronchiectasis)
• COPD participants will have fixed airway obstruction on spirometry less than 70%-predicted as per Global Initiative for Obstructive Lung Disease (GOLD) diagnostic criteria
• Participants will self-report as being ambulatory outside of home without use of assistance device such as a cane or walker
• Stable lung disease on stable medical therapy for preceding 3 months
• Isolated exertional hypoxemia (SpO2 less than 89% for \>=10 seconds) on a 6MWT conducted while breathing room air
• Able to maintain SpO2 \>=89% for the full duration of a 6MWT while using the the POC and portable oxygen D-tank at POC setting of no higher than 6 and D-tank flow rate no higher than 6 liters per minute

You may not qualify if:

• People \<18 years old or \>85 years old
• Participants with mixed ILD and COPD diagnoses
• Resting hypoxemia less than 89% while breathing room air
• Emergency room visit or hospital admission in 3 months prior to recruitment
• Change in medical therapy in 3 months prior to recruitment
• Need for ambulatory assistive device such as cane or walker
• Pregnant
• Currently smoking or residing with a current smoker
• Currently engaged in a pulmonary rehabilitation program
• Participants without a smartphone compatible with the Oxiwear app (necessary to collect Oxiwear oxygen saturation data) or those with a compatible smartphone but without home wifi or cellular service plan allowing for Oxiwear data uploading

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

State University of New York at Buffalo Jacobs School of Medicine and Biomedical Sciences

Buffalo, New York, 14203, United States

RECRUITING

Related Publications (63)

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Related Links

• Oxiwear ear-worn pulse oximeter
• Supplemental Oxygen Access Reform (SOAR) Act
• SOAR Act Joint Statement
• 2025 Global Initiative for Obstructive Lund Disease (GOLD) Report

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Kristopher Clark, MD

  State University of Buffalo Jacobs School of Medicine and Biomedical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristopher Clark, MD

CONTACT

7168591516; kclark4@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: This pilot study is a prospective, randomized, crossover clinical trial to test the feasibility of our experimental design and obtain preliminary assessments on the effect of ambulatory oxygen therapy (AOT) devices compared to no oxygen on real-world activity, dyspnea, and quality-of-life in people with fibrotic ILD or COPD with isolated exertional hypoxemia. Participants will be randomized to sequential 2-week periods of 1) no AOT therapy or AOT delivered via 2) a portable oxygen concentrator (POC) or 3) portable oxygen canisters. The POC setting and oxygen canister flow rates will be titrated to relieve hypoxemia on a 6-minute walk test (6MWT). 6MWT along with dyspnea and quality-of-life surveys will be measured at baseline and every 2 weeks. Surveys used will include the EuroQol 5-Domain 5-Level (EQ-5D-5L) questionnaire, Dyspnoea-12, King's Brief Interstitial Lung Disease (K-BILD) questionnaire, and the COPD Assessment Test (CAT).

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data may be available after completion of the study and may be available indefinitely.
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal to achieve the objectives in the approved proposal. Proposals should be directed to kclark4@buffalo.edu.

Locations

US (1)