Not Yet RecruitingNot Applicable

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

24 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Pregnant * Currently smoking or residing with a current smoker * Currently engaged in a pulmonary rehabilitation program * Participa…

What they're measuring

Steps Per Day

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

Trial details

NCT IDNCT07512687

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Kristopher Clark, MD

7168591516 kclark4@buffalo.edu