Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorState University of New York at Buffalo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Portable Oxygen Concentrator
DeviceInogen 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-tanks
DevicePortable 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
Other interventionNo ambulatory oxygen therapy will be provided.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Fibrotic Interstitial Lung DiseaseActive comparator 3 interventions
Group B: Chronic obstructive pulmonary diseaseActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
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).Secondary outcomes
1
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 intervention2
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 intervention3
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 completion4
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 completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
State University of New York at Buffalo
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Source ClinicalTrials.gov