[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632361":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":45,"responsibleParty":67,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":26,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"State University of New York at Buffalo","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Fibrotic Interstitial Lung Disease","ACTIVE_COMPARATOR","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.",[13,14,15],"Device: Portable Oxygen Concentrator","Device: Portable compressed oxygen D-tanks","Other: No ambulatory oxygen therapy",{"label":17,"type":10,"description":18,"interventionNames":19},"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.",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","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 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.",[17,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[17,9],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"No ambulatory oxygen therapy","No ambulatory oxygen therapy will be provided.",[17,9],[36],{"name":37,"affiliation":38,"role":39},"Kristopher Clark, MD","State University of Buffalo Jacobs School of Medicine and Biomedical Sciences","PRINCIPAL_INVESTIGATOR",[41],{"name":37,"role":42,"phone":43,"phoneExt":26,"email":44},"CONTACT","7168591516","kclark4@buffalo.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"State University of New York at Buffalo Jacobs School of Medicine and Biomedical Sciences","RECRUITING","Buffalo","New York","14203","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-78.87837,42.88645,{"lat":58,"lon":57},[61,62,66],{"name":37,"role":42,"phone":43,"phoneExt":26,"email":44},{"name":63,"role":42,"phone":64,"phoneExt":26,"email":65},"Maja Tankoska","716-888-4751","majatank@buffalo.edu",{"name":37,"role":39,"phone":26,"phoneExt":26,"email":26},{"type":39,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Kristopher Clark","Clinical Assistant Professor",[71],{"name":72,"class":73},"National Center for Advancing Translational Sciences (NCATS)","NIH","100632361","titrated-ambulatory-oxygen-in-fibrotic-ild-and-copd-with-isolated-exertional-hypoxemia-100632361",false,"NCT07512687","Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia","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)","Inclusion Criteria:\n\n* Adults \\>= 18 years old and \\\u003C= 85 years old with fibrotic ILD or COPD able to provide informed consent\n* Fibrotic ILD includes idiopathic pulmonary fibrosis, sarcoidosis, or other ILD with fibrotic changes on lung imaging (reticulations, honeycombing, traction bronchiectasis)\n* COPD participants will have fixed airway obstruction on spirometry less than 70%-predicted as per Global Initiative for Obstructive Lung Disease (GOLD) diagnostic criteria\n* Participants will self-report as being ambulatory outside of home without use of assistance device such as a cane or walker\n* Stable lung disease on stable medical therapy for preceding 3 months\n* Isolated exertional hypoxemia (SpO2 less than 89% for \\>=10 seconds) on a 6MWT conducted while breathing room air\n* 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\n\nExclusion Criteria:\n\n* People \\\u003C18 years old or \\>85 years old\n* Participants with mixed ILD and COPD diagnoses\n* Resting hypoxemia less than 89% while breathing room air\n* Emergency room visit or hospital admission in 3 months prior to recruitment\n* Change in medical therapy in 3 months prior to recruitment\n* Need for ambulatory assistive device such as cane or walker\n* Pregnant\n* Currently smoking or residing with a current smoker\n* Currently engaged in a pulmonary rehabilitation program\n* 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","ALL","18 Years","85 Years",{"count":85,"type":86},24,"ESTIMATED","INTERVENTIONAL",[89],"NA","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.\n\nThis 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.",[92,93,94],"Interstitial Lung Disease","Chronic Obstructive Pulmonary Disease","Hypoxemia",[96,23,97,98,99],"Ambulatory Oxygen Therapy","Exertional Hypoxemia","6-Minute Walk Test","Real-World Activity","2026-06-08",{"date":102,"type":103},"2026-06-11","ACTUAL",{"date":105,"type":86},"2026-07",{"date":107,"type":86},"2027-10",{"name":5,"class":6},1]