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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Portable Oxygen Concentrator
  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 batte
• Устройство Portable compressed oxygen D-tanks
  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.
• Другое No ambulatory oxygen therapy
  No ambulatory oxygen therapy will be provided.

Первичные конечные точки

• Steps Per Day [Срок оценки: Daily steps during each 2-week intervention (POC, D-Tank, no oxygen therapy).]

Вторичные конечные точки (9)

• Mean Daily Oxygen Saturation (SpO2) [Срок оценки: Daily oxygen saturation averaged over 2-weeks for each intervention]
• Time Spent With Oxygen Saturation (SpO2) Less Than 89% [Срок оценки: Oxygen saturation measured continuously during activity for each 2-week intervention]
• Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score [Срок оценки: Baseline and at end of each 2-week intervention through study completion]
• Change in Kings Brief Interstitial Lung Disease (K-BILD) Score [Срок оценки: Baseline and at end of each 2-week intervention through study completion]
• Change in COPD Assessment Test (CAT) Score [Срок оценки: Baseline and at end of each 2-week intervention through study completion]
• Change in Dyspnoea-12 Score [Срок оценки: Baseline and at end of each 2-week intervention through study completion]
• Change in 6-Minute Walk Distance (6MWD) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Daily equipment use over 2-week periods with each intervention (POC and D-tank)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• State University of New York at Buffalo Jacobs School of Medicine and Biomedical Sciences — Buffalo

Публикации

• 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. PMID 12917227
• Jacobs 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 PMID 33185464
• Collard 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. PMID 22455577
• Wang 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. PMID 32776789
• Kent 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. PMID 21660297
• Khor 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. PMID 30377245
• Du 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. PMID 29193512
• Andrianopoulos 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. PMID 24121092

Идентификаторы

NCT: NCT07512687 · STUDY0001017 · K12TR005295

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗