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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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 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 therapy will be provided.
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.
Time frame: Daily steps during each 2-week intervention (POC, D-Tank, no oxygen therapy).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: Daily equipment use over 2-week periods with each intervention (POC and D-tank)
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