NCT07512687 · State University of New York at Buffalo
Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Where
- Buffalo, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations