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)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Steps Per Day
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Fibrotic Interstitial Lung Disease
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.
干预措施: Portable compressed oxygen D-tanks (Device)
Chronic obstructive pulmonary disease
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.
干预措施: No ambulatory oxygen therapy (Other)
Chronic obstructive pulmonary disease
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.
干预措施: Portable Oxygen Concentrator (Device)
Fibrotic Interstitial Lung Disease
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.
干预措施: Portable Oxygen Concentrator (Device)
Fibrotic Interstitial Lung Disease
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.
干预措施: No ambulatory oxygen therapy (Other)
Chronic obstructive pulmonary disease
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.
干预措施: Portable compressed oxygen D-tanks (Device)
结局指标
主要结局
Steps Per Day
时间窗: 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.
次要结局
- 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)
- Change in Dyspnoea-12 Score(Baseline and at end of each 2-week intervention through study completion)
- Change in 6-Minute Walk Distance (6MWD)(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(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(Daily equipment use over 2-week periods with each intervention (POC and D-tank))
研究者
Kristopher Clark
Clinical Assistant Professor
State University of New York at Buffalo