Interstitial Lung DiseaseNCT07512687
Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia
A study testing Portable Oxygen Concentrator, Portable compressed oxygen D-tanks and No ambulatory oxygen therapy in people with Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, Hypoxemia
- What is being tested?
- Portable Oxygen Concentrator, Portable compressed oxygen D-tanks and No ambulatory oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
State University of New York at Buffalo Jacobs School of Medicine and Biomedical Sciences
Buffalo, New York, 14203
About this study
Official title: Impact of Ambulatory Oxygen Delivery on Real-world Activity and Quality-of-life in Patients With Interstitial Lung Disease (ILD) and Chronic Obstructive Pulmonary Disease (COPD)
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.
Read the detailed description
Interstitial lung diseases (ILD) are a group of diseases that frequently affect the gas-exchange surface of the lungs. Many forms of ILD are fibrotic in which the lung tissue becomes scarred, and patients with fibrotic ILD often have low oxygen levels at rest or with activity. Low oxygen levels are also common in chronic obstructive pulmonary disease (COPD). COPD is most often caused by tobacco use and can lead to damage to lung tissue that also affects how well oxygen can get into the blood. Low blood oxygen levels are associated with shortness of breath and adverse outcomes in fibrotic ILD and COPD including increased mortality and reduced quality-of-life. Long term oxygen therapy (LTOT) used for >15 hours per day is strongly recommended in patients with fibrotic ILD or COPD who have low oxygen level at rest based on studies in COPD which showed that LTOT improved mortality. Up to 50% of patients with fibrotic ILD and 25-50% with COPD only have low oxygen levels with activity, termed isolated exertional hypoxemia. Laboratory- and clinic-based studies on ambulatory oxygen therapy (AOT) given during exercise demonstrated improvement in shortness of breath and exercise ability. However, studies on real-world AOT use have not found a significant or consistent benefit in clinical outcomes, patient activity, symptoms, or quality-of-life. This has led to variable AOT prescribing practices worldwide.
AOT can be delivered via portable oxygen concentrators (POC), compressed gas canisters, or liquid reservoirs. Differences in device size, weight, portability, and continuous vs on-demand oxygen delivery likely impact patient activity. Many patients, especially those with fibrotic ILD, often need ambulatory oxygen at high flow rates which exceeds the ability of commonly used POCs. How much oxygen a patient needs with activity is usually determined through a hallway walk test, however it's not known whether these tests accurately predict a patient's real-world oxygen needs, or if AOT titrated to correct low oxygen levels on these tests also correct low oxygen levels during real-world activities.
This study will test the feasibility of a larger clinical trial examining how AOT delivery, titrated to meet individual participant's ambulatory oxygen needs during a hallway walk test, impacts real-world activity, symptoms, and quality-of-life in people with fibrotic ILD or COPD who only have low oxygen levels with activity. We aim to examine the effects of AOT delivered between oxygen tanks and POCs compared to each other and to no oxygen therapy where participants do normal real-world activities breathing regular air. A total of 12 people with fibrotic ILD and 12 people with COPD (24 people total) who only have low oxygen levels with walking will be invited to participate. This study will be conducted at a single site in the United States. All participants will be assigned to 2-week periods using a POC, oxygen tanks, or no oxygen therapy during their normal real-world activities. POC and oxygen tank delivery will be titrated to correct low oxygen levels on a hallway walk test. Measurements of daily activity and real-world oxygen saturations will be continuously measured for the total 6-week study. Measurements of symptoms and quality-of-life will be obtained at the beginning of the study and every 2-weeks. Information about participants' fibrotic ILD and COPD diagnoses and treatments will be collected.
- Being tested
- Portable Oxygen Concentrator, Portable compressed oxygen D-tanks, No ambulatory oxygen therapy
- Keywords
- Ambulatory Oxygen Therapy, Portable Oxygen Concentrator, Exertional Hypoxemia, 6-Minute Walk Test, Real-World Activity
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable Oxygen ConcentratorDevice
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.
Portable compressed oxygen D-tanksDevice
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.
No ambulatory oxygen therapyOther
No ambulatory oxygen therapy will be provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Portable Oxygen Concentrator; Device: Portable compressed oxygen D-tanks; Other: No ambulatory oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily steps during each 2-week intervention (POC, D-Tank, no oxygen therapy).
Secondary outcomes (9)
Mean Daily Oxygen Saturation (SpO2)
This secondary outcome is mean daily SpO2 between AOT delivery devices (POC and D-tanks) and compared to no oxygen therapy. Oxygen saturation during real-world activity will be measured with use of Oxiwear, an ear-worn pulse oximeter FDA-cleared for oxygen saturation measurement during activity. A select number of participants (fibrotic ILD=3, COPD=3) will be randomly selected to use a Nonin WristOx2 finger pulse oximeter connected to a wrist-worn interface to collect oxygen saturation data for 2 consecutive days during each 2-week period to corroborate Oxiwear measurements.
Measured: Daily oxygen saturation averaged over 2-weeks for each intervention
Time Spent With Oxygen Saturation (SpO2) Less Than 89%
This secondary outcome is the mean amount time spent with SpO2 of less 89% during real-world activity. Time SpO2 less than 89% will be averaged over 2-weeks for each intervention. SpO2 during real-world activity will be measured with use of Oxiwear, an ear-worn pulse oximeter FDA-cleared for oxygen saturation measurement during activity. A select number of participants (fibrotic ILD=3, COPD=3) will be randomly selected to use a Nonin WristOx2 finger pulse oximeter connected to a wrist-worn interface to collect oxygen saturation data for 2 consecutive days during each 2-week period to corroborate Oxiwear measurements.
Measured: Oxygen saturation measured continuously during activity for each 2-week intervention
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score
This secondary outcome is change in quality-of-life score as measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) tool which assesses how participants describe their health on that day. Scores will be measured for all participants at baseline and after each 2-week intervention period. The tool consists of 5 domains which have 5 levels each. Participants chose one level per domain. A higher level response represents a greater severity within that domain. A unique health state is identified by a 5-digit code representing the level in each domain. Participants also indicate on a scale of 0 (worse health you can imagine) to 100 (best health you can imagine) how their health is today. Aggregate scores will be compared between baseline and each intervention. Scores with each intervention (POC, oxygen tanks, no oxygen therapy) will be compared to baseline, and scores with each oxygen intervention (POC and oxygen tanks) will be compared to each other and to the no oxygen intervention score.
Measured: Baseline and at end of each 2-week intervention through study completion
Change in Kings Brief Interstitial Lung Disease (K-BILD) Score
This secondary outcome is change in score of the King's Brief Interstitial Lung Disease (K-BILD) questionnaire. The questionnaire consists of 15 questions evaluating health status including symptoms across 3 domains. Questions ask about health status and symptoms over the preceding 2-weeks. Each question is scored from 1 to 5 with a lower number indicating more frequent symptoms or more impaired health status. The K-BILD will only be completed by participants with ILD. Scores will be collected at baseline and after each 2-week intervention. Scores with each intervention (POC, oxygen tanks, no oxygen therapy) will be compared to baseline, and scores with each oxygen intervention (POC and oxygen tanks) will be compared to each other and to the no oxygen intervention score.
Measured: Baseline and at end of each 2-week intervention through study completion
Change in COPD Assessment Test (CAT) Score
This secondary outcome is change in score of the COPD Assessment Test (CAT). The CAT consists of 8 questions related to participant's symptoms, activity and other health measures. Each question is scored from 0 to 5 with a higher number indicating more severe symptoms or more impaired health status. An aggregate score is calculated from the sum of all 8 questions. An aggregate score of <10 is considered low impact, 10-20 medium impact, 20-30 high impact, and >30 very high impact. The CAT will only be completed by participants with COPD. Scores will be obtained at baseline and after each 2-week intervention. Scores with each intervention (POC, oxygen tanks, no oxygen therapy) will be compared to baseline, and scores with each oxygen intervention (POC and oxygen tanks) will be compared to each other and to the no oxygen intervention score.
Measured: Baseline and at end of each 2-week intervention through study completion
Change in Dyspnoea-12 Score
This secondary outcome is the change in dyspnea score measured by the Dyspnoea-12 tool. The Dyspnoea-12 consists of 12 questions related to the participant's breathing. Each question is scored on a 4-point Likert scale: 0 None, 1 Mild, 2 Moderate, or 3 Severe. Higher scores represent more significant symptoms or impact from breathing issues. An aggregate score is the sum of all question scores. Scores with each intervention (POC, oxygen tanks, no oxygen therapy) will be compared to baseline, and scores with each oxygen intervention (POC and oxygen tanks) will be compared to each other and to the no oxygen intervention score.
Measured: Baseline and at end of each 2-week intervention through study completion
Change in 6-Minute Walk Distance (6MWD)
This secondary outcome is the change in 6MWD with use of POC and portable D-tank compared to each other and to no oxygen therapy. A 6-Minute Walk Test (6MWT) will be completed on no oxygen therapy and with use of POC and D-Tank prior to randomization. At the completion of each 2-week intervention, the 6MWT will be repeated on whichever device (or no oxygen therapy) the participant had been randomized to for the preceding 2 weeks. The longest 6MWD with each intervention will be used.
Measured: At baseline and at start and end dates of each 2-week intervention period through study completion
Nadir Oxygen Saturation (SpO2) Between 6MWT and Real-World Activity
This secondary outcome is the difference in nadir SpO2 noted on 6MWT compared to mean nadir SpO2 recorded during the 2-week period with use of the corresponding intervention.
Measured: 6MWT nadir SpO2 recorded at baseline and at completion of 2-week period with assigned intervention. Nadir SpO2 during real-world activity measured daily and averaged for each 2-week period with each intervention.
Ambulatory Oxygen Equipment Use Time
This secondary outcome is the difference in estimated time participants use the POC and D-tanks. POC use time will be obtained directly from the Inogen Rove 6 device. D-tank use time will be estimated based on the number of oxygen canisters used and the prescribed oxygen flow rate the participant was instructed to use.
Measured: Daily equipment use over 2-week periods with each intervention (POC and D-tank)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start2 Sep 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Kristopher Clark, State University of New York at Buffalo
- Investigators
- Kristopher Clark, MD, Principal investigator, State University of Buffalo Jacobs School of Medicine and Biomedical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512687
- Sponsor's protocol ID
- STUDY0001017
- Other IDs
- K12TR005295
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data may be made available upon request.
Publications
Lama VN, Flaherty KR, Toews GB, Colby TV, Travis WD, Long Q, Murray S, Kazerooni EA, Gross BH, Lynch JP 3rd, Martinez FJ. Prognostic value of desaturation during a 6-minute walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1084-90. doi: 10.1164/rccm.200302-219OC. Epub 2003 Aug 13.
PubMed 12917227Jacobs SS, Krishnan JA, Lederer DJ, Ghazipura M, Hossain T, Tan AM, Carlin B, Drummond MB, Ekstrom M, Garvey C, Graney BA, Jackson B, Kallstrom T, Knight SL, Lindell K, Prieto-Centurion V, Renzoni EA, Ryerson CJ, Schneidman A, Swigris J, Upson D, Holland AE. Home Oxygen Therapy for Adults with Chronic Lung Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Nov 15;202(10):e121-e141. doi: 10.1164/rccm.202009-3608ST.
PubMed 33185464Collard HR, Ward AJ, Lanes S, Cortney Hayflinger D, Rosenberg DM, Hunsche E. Burden of illness in idiopathic pulmonary fibrosis. J Med Econ. 2012;15(5):829-35. doi: 10.3111/13696998.2012.680553. Epub 2012 Apr 25.
PubMed 22455577Wang BR, Edwards R, Freiheit EA, Ma Y, Burg C, de Andrade J, Lancaster L, Lindell K, Nathan SD, Raghu G, Gibson K, Gulati M, Mason W, Noth I, Schmidt B, Spino C, Staszak S, Stauffer J, Wolters PJ, Cosgrove GP, Flaherty KR. The Pulmonary Fibrosis Foundation Patient Registry. Rationale, Design, and Methods. Ann Am Thorac Soc. 2020 Dec;17(12):1620-1628. doi: 10.1513/AnnalsATS.202001-035SD.
PubMed 32776789Kent BD, Mitchell PD, McNicholas WT. Hypoxemia in patients with COPD: cause, effects, and disease progression. Int J Chron Obstruct Pulmon Dis. 2011;6:199-208. doi: 10.2147/COPD.S10611. Epub 2011 Mar 14.
PubMed 21660297Khor YH, Goh NS, Glaspole I, Holland AE, McDonald CF. Exertional Desaturation and Prescription of Ambulatory Oxygen Therapy in Interstitial Lung Disease. Respir Care. 2019 Mar;64(3):299-306. doi: 10.4187/respcare.06334. Epub 2018 Oct 30.
PubMed 30377245Du Plessis JP, Fernandes S, Jamal R, Camp P, Johannson K, Schaeffer M, Wilcox PG, Guenette JA, Ryerson CJ. Exertional hypoxemia is more severe in fibrotic interstitial lung disease than in COPD. Respirology. 2018 Apr;23(4):392-398. doi: 10.1111/resp.13226. Epub 2017 Nov 28.
PubMed 29193512Andrianopoulos V, Franssen FM, Peeters JP, Ubachs TJ, Bukari H, Groenen M, Burtin C, Vogiatzis I, Wouters EF, Spruit MA. Exercise-induced oxygen desaturation in COPD patients without resting hypoxemia. Respir Physiol Neurobiol. 2014 Jan 1;190:40-6. doi: 10.1016/j.resp.2013.10.002. Epub 2013 Oct 9.
PubMed 24121092Clark KP, Nouraie SM, Lindell KO, Gibson KF, Sciurba FC, Bon J, Kass DJ. A Ramped Treadmill Protocol Exercise Test Identifies Higher Ambulatory Oxygen Needs in Idiopathic Pulmonary Fibrosis and Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2025 Apr;22(4):541-548. doi: 10.1513/AnnalsATS.202404-419OC.
PubMed 39565187Ameer F, Carson KV, Usmani ZA, Smith BJ. Ambulatory oxygen for people with chronic obstructive pulmonary disease who are not hypoxaemic at rest. Cochrane Database Syst Rev. 2014 Jun 24;2014(6):CD000238. doi: 10.1002/14651858.CD000238.pub2.
PubMed 24957353Bye PT, Anderson SD, Woolcock AJ, Young IH, Alison JA. Bicycle endurance performance of patients with interstitial lung disease breathing air and oxygen. Am Rev Respir Dis. 1982 Dec;126(6):1005-12. doi: 10.1164/arrd.1982.126.6.1005.
PubMed 7181219Dowman LM, McDonald CF, Bozinovski S, Vlahos R, Gillies R, Pouniotis D, Hill CJ, Goh NSL, Holland AE. Greater endurance capacity and improved dyspnoea with acute oxygen supplementation in idiopathic pulmonary fibrosis patients without resting hypoxaemia. Respirology. 2017 Jul;22(5):957-964. doi: 10.1111/resp.13002. Epub 2017 Feb 22.
PubMed 28225205Jolly EC, Di Boscio V, Aguirre L, Luna CM, Berensztein S, Gene RJ. Effects of supplemental oxygen during activity in patients with advanced COPD without severe resting hypoxemia. Chest. 2001 Aug;120(2):437-43. doi: 10.1378/chest.120.2.437.
PubMed 11502641O'Donnell DE, D'Arsigny C, Webb KA. Effects of hyperoxia on ventilatory limitation during exercise in advanced chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Mar;163(4):892-8. doi: 10.1164/ajrccm.163.4.2007026.
PubMed 11282762Schaeffer MR, Ryerson CJ, Ramsook AH, Molgat-Seon Y, Wilkie SS, Dhillon SS, Mitchell RA, Sheel AW, Khalil N, Camp PG, Guenette JA. Effects of hyperoxia on dyspnoea and exercise endurance in fibrotic interstitial lung disease. Eur Respir J. 2017 May 25;49(5):1602494. doi: 10.1183/13993003.02494-2016. Print 2017 May. No abstract available.
PubMed 28546272
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ambulatory Oxygen Delivery on Real-world Activity and Quality-of-life in Patients With Interstitial Lung Disease (ILD) and Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07512687
- Acronym / sponsor ID
- STUDY0001017
- Keywords
- Ambulatory Oxygen Therapy, Portable Oxygen Concentrator, Exertional Hypoxemia, 6-Minute Walk Test, Real-World Activity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Interstitial lung diseases (ILD) are a group of diseases that frequently affect the gas-exchange surface of the lungs. Many forms of ILD are fibrotic in which the lung tissue becomes scarred, and patients with fibrotic ILD often have low oxygen levels at rest or with activity. Low oxygen levels are also common in chronic obstructive pulmonary disease (COPD). COPD is most often caused by tobacco use and can lead to damage to lung tissue that also affects how well oxygen can get into the blood. Low blood oxygen levels are associated with shortness of breath and adverse outcomes in fibrotic ILD and COPD including increased mortality and reduced quality-of-life. Long term oxygen therapy (LTOT) used for >15 hours per day is strongly recommended in patients with fibrotic ILD or COPD who have low oxygen level at rest based on studies in COPD which showed that LTOT improved mortality. Up to 50% of patients with fibrotic ILD and 25-50% with COPD only have low oxygen levels with activity, termed isolated exertional hypoxemia. Laboratory- and clinic-based studies on ambulatory oxygen therapy (AOT) given during exercise demonstrated improvement in shortness of breath and exercise ability. However, studies on real-world AOT use have not found a significant or consistent benefit in clinical outcomes, patient activity, symptoms, or quality-of-life. This has led to variable AOT prescribing practices worldwide.
AOT can be delivered via portable oxygen concentrators (POC), compressed gas canisters, or liquid reservoirs. Differences in device size, weight, portability, and continuous vs on-demand oxygen delivery likely impact patient activity. Many patients, especially those with fibrotic ILD, often need ambulatory oxygen at high flow rates which exceeds the ability of commonly used POCs. How much oxygen a patient needs with activity is usually determined through a hallway walk test, however it's not known whether these tests accurately predict a patient's real-world oxygen needs, or if AOT titrated to correct low oxygen levels on these tests also correct low oxygen levels during real-world activities.
This study will test the feasibility of a larger clinical trial examining how AOT delivery, titrated to meet individual participant's ambulatory oxygen needs during a hallway walk test, impacts real-world activity, symptoms, and quality-of-life in people with fibrotic ILD or COPD who only have low oxygen levels with activity. We aim to examine the effects of AOT delivered between oxygen tanks and POCs compared to each other and to no oxygen therapy where participants do normal real-world activities breathing regular air. A total of 12 people with fibrotic ILD and 12 people with COPD (24 people total) who only have low oxygen levels with walking will be invited to participate. This study will be conducted at a single site in the United States. All participants will be assigned to 2-week periods using a POC, oxygen tanks, or no oxygen therapy during their normal real-world activities. POC and oxygen tank delivery will be titrated to correct low oxygen levels on a hallway walk test. Measurements of daily activity and real-world oxygen saturations will be continuously measured for the total 6-week study. Measurements of symptoms and quality-of-life will be obtained at the beginning of the study and every 2-weeks. Information about participants' fibrotic ILD and COPD diagnoses and treatments will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Fibrotic Interstitial Lung Disease | Active comparator | Device: Portable Oxygen Concentrator, Device: Portable compressed oxygen D-tanks, Other: No ambulatory oxygen therapyParticipants 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. |
| Chronic obstructive pulmonary disease | Active comparator | Device: Portable Oxygen Concentrator, Device: Portable compressed oxygen D-tanks, Other: No ambulatory oxygen therapyParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable Oxygen ConcentratorInogen 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. | Device | Chronic obstructive pulmonary disease, Fibrotic Interstitial Lung Disease |
| Portable compressed oxygen D-tanksPortable 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. | Device | Chronic obstructive pulmonary disease, Fibrotic Interstitial Lung Disease |
| No ambulatory oxygen therapyNo ambulatory oxygen therapy will be provided. | Other | Chronic obstructive pulmonary disease, Fibrotic Interstitial Lung Disease |
Primary outcome
Steps Per Day
Time frame: Daily steps during each 2-week intervention (POC, D-Tank, no oxygen therapy).
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.
9 secondary outcomes
Mean Daily Oxygen Saturation (SpO2)
Time frame: Daily oxygen saturation averaged over 2-weeks for each intervention
Time Spent With Oxygen Saturation (SpO2) Less Than 89%
Time frame: Oxygen saturation measured continuously during activity for each 2-week intervention
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score
Time frame: Baseline and at end of each 2-week intervention through study completion
Change in Kings Brief Interstitial Lung Disease (K-BILD) Score
Time frame: Baseline and at end of each 2-week intervention through study completion
Change in COPD Assessment Test (CAT) Score
Time frame: Baseline and at end of each 2-week intervention through study completion
Change in Dyspnoea-12 Score
Time frame: Baseline and at end of each 2-week intervention through study completion
Change in 6-Minute Walk Distance (6MWD)
Time frame: At baseline and at start and end dates of each 2-week intervention period through study completion
Nadir Oxygen Saturation (SpO2) Between 6MWT and Real-World Activity
Time frame: 6MWT nadir SpO2 recorded at baseline and at completion of 2-week period with assigned intervention. Nadir SpO2 during real-world activity measured daily and averaged for each 2-week period with each intervention.
Ambulatory Oxygen Equipment Use Time
Time frame: Daily equipment use over 2-week periods with each intervention (POC and D-tank)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 12917227Lama VN, Flaherty KR, Toews GB, Colby TV, Travis WD, Long Q, Murray S, Kazerooni EA, Gross BH, Lynch JP 3rd, Martinez FJ. Prognostic value of desaturation during a 6-minute walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1084-90. doi: 10.1164/rccm.200302-219OC. Epub 2003 Aug 13.
- Background: PubMed 33185464Jacobs SS, Krishnan JA, Lederer DJ, Ghazipura M, Hossain T, Tan AM, Carlin B, Drummond MB, Ekstrom M, Garvey C, Graney BA, Jackson B, Kallstrom T, Knight SL, Lindell K, Prieto-Centurion V, Renzoni EA, Ryerson CJ, Schneidman A, Swigris J, Upson D, Holland AE. Home Oxygen Therapy for Adults with Chronic Lung Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Nov 15;202(10):e121-e141. doi: 10.1164/rccm.202009-3608ST.
- Background: PubMed 22455577Collard HR, Ward AJ, Lanes S, Cortney Hayflinger D, Rosenberg DM, Hunsche E. Burden of illness in idiopathic pulmonary fibrosis. J Med Econ. 2012;15(5):829-35. doi: 10.3111/13696998.2012.680553. Epub 2012 Apr 25.
- Background: PubMed 32776789Wang BR, Edwards R, Freiheit EA, Ma Y, Burg C, de Andrade J, Lancaster L, Lindell K, Nathan SD, Raghu G, Gibson K, Gulati M, Mason W, Noth I, Schmidt B, Spino C, Staszak S, Stauffer J, Wolters PJ, Cosgrove GP, Flaherty KR. The Pulmonary Fibrosis Foundation Patient Registry. Rationale, Design, and Methods. Ann Am Thorac Soc. 2020 Dec;17(12):1620-1628. doi: 10.1513/AnnalsATS.202001-035SD.
- Background: PubMed 21660297Kent BD, Mitchell PD, McNicholas WT. Hypoxemia in patients with COPD: cause, effects, and disease progression. Int J Chron Obstruct Pulmon Dis. 2011;6:199-208. doi: 10.2147/COPD.S10611. Epub 2011 Mar 14.
- Background: PubMed 30377245Khor YH, Goh NS, Glaspole I, Holland AE, McDonald CF. Exertional Desaturation and Prescription of Ambulatory Oxygen Therapy in Interstitial Lung Disease. Respir Care. 2019 Mar;64(3):299-306. doi: 10.4187/respcare.06334. Epub 2018 Oct 30.
- Background: PubMed 29193512Du Plessis JP, Fernandes S, Jamal R, Camp P, Johannson K, Schaeffer M, Wilcox PG, Guenette JA, Ryerson CJ. Exertional hypoxemia is more severe in fibrotic interstitial lung disease than in COPD. Respirology. 2018 Apr;23(4):392-398. doi: 10.1111/resp.13226. Epub 2017 Nov 28.
- Background: PubMed 24121092Andrianopoulos V, Franssen FM, Peeters JP, Ubachs TJ, Bukari H, Groenen M, Burtin C, Vogiatzis I, Wouters EF, Spruit MA. Exercise-induced oxygen desaturation in COPD patients without resting hypoxemia. Respir Physiol Neurobiol. 2014 Jan 1;190:40-6. doi: 10.1016/j.resp.2013.10.002. Epub 2013 Oct 9.
- Background: PubMed 39565187Clark KP, Nouraie SM, Lindell KO, Gibson KF, Sciurba FC, Bon J, Kass DJ. A Ramped Treadmill Protocol Exercise Test Identifies Higher Ambulatory Oxygen Needs in Idiopathic Pulmonary Fibrosis and Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2025 Apr;22(4):541-548. doi: 10.1513/AnnalsATS.202404-419OC.
- Background: PubMed 24957353Ameer F, Carson KV, Usmani ZA, Smith BJ. Ambulatory oxygen for people with chronic obstructive pulmonary disease who are not hypoxaemic at rest. Cochrane Database Syst Rev. 2014 Jun 24;2014(6):CD000238. doi: 10.1002/14651858.CD000238.pub2.
- Background: PubMed 7181219Bye PT, Anderson SD, Woolcock AJ, Young IH, Alison JA. Bicycle endurance performance of patients with interstitial lung disease breathing air and oxygen. Am Rev Respir Dis. 1982 Dec;126(6):1005-12. doi: 10.1164/arrd.1982.126.6.1005.
- Background: PubMed 28225205Dowman LM, McDonald CF, Bozinovski S, Vlahos R, Gillies R, Pouniotis D, Hill CJ, Goh NSL, Holland AE. Greater endurance capacity and improved dyspnoea with acute oxygen supplementation in idiopathic pulmonary fibrosis patients without resting hypoxaemia. Respirology. 2017 Jul;22(5):957-964. doi: 10.1111/resp.13002. Epub 2017 Feb 22.
- Oxiwear ear-worn pulse oximeterLink provided by the sponsor.
- SOAR Act Joint StatementLink provided by the sponsor.
- 2025 Global Initiative for Obstructive Lund Disease (GOLD) ReportLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data may be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristopher Clark, MD principal investigator
State University of Buffalo Jacobs School of Medicine and Biomedical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Oxygen Concentrator, Portable compressed oxygen D-tanks and No ambulatory oxygen therapy in people with Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps Per Day (time frame: Daily steps during each 2-week intervention (POC, D-Tank, no oxygen therapy).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07512687, which also lists 63 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.