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New treatment option for Interstitial Lung Disease
Official title Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia
ClinicalTrials.gov ID: NCT07512687
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- COPD participants will have fixed airway obstruction on spirometry less than 70%-predicted as per Global Initiative for Obstructive Lung Disease...
- 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
You likely can't join if
- People \ 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
See the full eligibility criteria
- 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
- People \ 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...
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.