An interventional study of Activated ROAM System with User Feedback and Sham Comparator in COPD and COPD - Chronic Obstructive Pulmonary Disease, sponsored by Barron Associates, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Barron Associates, Inc. · Not applicable, Interventional, and Health services research
Among 1,278 studies in Pulmonary Disease, Chronic Obstructive with a site in United States — 138 open to participants now, 172 under way, 20 of them phase 3. Pulmonary Disease, Chronic Obstructive · United States.
Among the 1,278 studies in Pulmonary Disease, Chronic Obstructive with a site in United States, this one is the 511th largest by planned enrollment of the 1,037 interventional ones that give a count, is one of 45 that started in 2025, is one of 395 with no phase, reaches primary completion later than 28 of the 171 other live ones, and was the 1,199th registered.
5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →138 of the 1,278 studies in Pulmonary Disease, Chronic Obstructive with a site in United States are open now. Recruiting first, the newest first:
Cedars-Sinai Medical Center · Sites in United States
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States
Ages 40–80
Johns Hopkins University · Sites in United States
Ages 18–75 · Healthy volunteers
Enanta Pharmaceuticals, Inc · Sites in United States
Ages 18+
Regeneron Pharmaceuticals · Sites in United States
Ages 40+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 88 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,278 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 117 · Phase 2 230 · Phase 3 238 · Phase 4 98
First in 1994; this study’s year is marked. 45 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 100 across the 1,037 interventional studies, 171 across the 237 observational. Of the 1,018 that completed or were terminated, 502 (49%) have results posted.
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603 of 1,278 have an industry lead sponsor. The 10 most frequent:
Barron Associates, Inc. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Barron Associates, Inc. has 1 study filed under Pulmonary Disease, Chronic Obstructive — fewer than ten, so there is no comparison to draw.
62 of the studies in Pulmonary Disease, Chronic Obstructive with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05265299Phase 3Johns Hopkins UniversityTrial to Determine Effective Aspirin Dose in COPD | 2026-12 |
| NCT05878769Phase 3Hoffmann-La RocheA Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) | 2027-06-30 |
| NCT07555483Phase 3Grifols Therapeutics LLCA Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD) | 2027-09-30 |
| NCT04968249University of MichiganMichigan Early Disease Progression Cohort | 2026-12 |
| NCT05879211Duke UniversityGoal Concordant Care Learning Laboratory | 2026-12 |
Add all 62 to your calendar (.ics) → With an account.
Among the 1,278 studies in Pulmonary Disease, Chronic Obstructive with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to test a device called "ROAM" that is being developed to see how patients with chronic obstructive pulmonary disease (COPD) use oxygen therapy over a long period of time. This study will focus on evaluating the ROAM device, which will be attached to your oxygen source. The question that the study aims to answer is: will patients who receive daily adherence feedback from the ROAM have increased adherence to their prescribed long term oxygen therapy regimens?
Researchers will compare the amount of time using oxygen and attitudes about oxygen therapy observed in a group that receives feedback from ROAM, and a control group that does not receive feedback.
Participants will have their oxygen supplies fitted with the ROAM device and then use their oxygen as usual for the 5-week study duration. Participants in the study group will have access to information about their oxygen usage and pulse oximetry levels. All participants will attend two in-clinic sessions of about an hour each, and will complete questionnaires at the beginning and end of the study.
This clinical trial will be a conventional randomized, parallel controlled trial to evaluate the primary hypothesis that a 4-week period of using the ROAM adherence monitor and support system will result in increased adherence when compared to a control group with no adherence monitoring. The participant population will be individuals with chronic obstructive pulmonary disease (COPD), and who have been prescribed oxygen therapy for a minimum of 8 hours/day. Half of the participants will be randomly assigned to the ROAM group; the other half will comprise the control group.
All participants will bring their regular oxygen supplies to the clinic to be fitted with the ROAM sensors. To establish baseline adherence, for the first week, all participants will be blinded to feedback from the ROAM system (including oxygen usage times and oxygen saturation levels); a special code will disable feedback on the local system, including the adherence displays and notifications. After one week, the oxygen usage times will be averaged, and used as a baseline of adherence.
Control participants will continue to be blinded to the ROAM feedback for the next four weeks. After the first week, the ROAM group participants will be instructed to enter a code to enable the ROAM user feedback display on the concentrator and portable tank systems. These participants will be instructed to take pulse oximetry readings as they usually do using the ROAM system's included oximeter. A minimum of two readings per day will be encouraged by built-in alerts on the system. They will continue using the system, while receiving feedback on daily adherence rates and oxygen saturation levels, for the 4-week study duration.
The average daily oxygen use times over the four-week study period will be computed, and use times for the ROAM group will be compared to those of the control group. At the beginning and end of the study, patients will complete a questionnaire to assess attitudes toward treatment. The primary outcome metric will be adherence rates (% adherent = actual treatment time/prescribed treatment time) of the oxygen therapy. The secondary outcome metric will be attitude towards treatment, as assessed via questionnaires.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The ROAM group participants will have access to the ROAM user feedback display on their concentrator and portable tank oxygen delivery systems, throughout the 4-week study duration.
Device: Activated ROAM System with User Feedback
The control group participants will have their oxygen delivery concentrators and portable tanks fitted with the ROAM system, which will monitor their usage, but they will not receive any of the user feedback or have access to the ROAM software.
Device: Sham Comparator
The activated ROAM device will provide the user with daily information about their oxygen therapy usage and pulse oximetry.
The sham comparator is a ROAM device that monitors oxygen usage, but keeps the usage details blind to the user.
Adherence rates of oxygen therapy
Adherence rates are computed as the participant's average daily actual treatment time divided by the prescribed daily treatment time.
Time frame: From enrollment through completion of the study at 5 weeks
Patient Activation Model Scores
The Patient Activation Model (PAM) is an established, highly reliable, questionnaire that reflects a developmental model of patient engagement with their healthcare regimens.
Time frame: at the study completion at 5 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Apr 2026, 11 months later.
Of 87 industry-sponsored interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 11 months is below that.
Counting every sponsor, half of 1,182 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Barron Associates, Inc.