Chronic Obstructive Pulmonary DiseaseNCT05119556
Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease
A study testing Video Telehealth Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Alabama at Birmingham at 15 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to determine the impact on hospital readmissions and respiratory… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Video Telehealth Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 15 sitesUnited States
- Study dates
- 28 Jun 2022to 27 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 or greater
- Clinical diagnosis of COPD
- Hospitalized for acute exacerbation of COPD.
- Be willing to adhere to trial and follow-up procedures and give informed consent
Who cannot join
- Secondary diagnosis of congestive heart failure that is severe as documented by active symptoms, New York Heart Association (NYHA) functional classification IV or left ventricular ejection fraction <25% on echocardiography
- Other respiratory conditions that could confound the diagnosis such as asthma, pulmonary fibrosis, bronchiectasis, and lung cancer. Participants with pneumonic exacerbations of COPD will be included.
- Primary diagnosis of COVID pneumonia. Individuals with incidentally detected COVID or persistently positive for COVID but deemed to be convalescent will not be excluded.
- Active cancers on chemotherapy or radiation therapy
- Immunosuppressed states predisposing to frequent hospitalizations including uncontrolled HIV/AIDS
- Active or recent (within 1 month) myocardial infarction
Show all 18Show fewer
- Angina not well-controlled by medication
- Unstable cardiac arrhythmias, atrial or ventricular
- Supplemental oxygen requirement greater than 5 liters per minute at either rest or with exertion
- Significant cognitive dysfunction, including dementia, that in opinion of investigator would impair ability to safely or effectively engage in study protocol
- Participants with any terminal medical illnesses as diagnosed by a physician, and/or on hospice
- Currently enrolled in and participating in pulmonary rehabilitation
- Treatment with chronic or newly initiated home ventilatory support. Those on in-patient short-term non-invasive ventilation will not be excluded.
- Special patient groups such as prisoners and institutionalized patients
- Participants with musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program
- Current participation in any other interventional clinical trial
- Inability to understand and speak English during exercise sessions
- Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35233
HealthPartners Institute
Bloomington, Minnesota, 55440
Boston VA Hospital
Boston, Massachusetts, 02130
Northern Westchester Hospital/Northwell Health
Chappaqua, New York, 10514
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cincinnati VA Hospital
Cincinnati, Ohio, 45220
Cleveland Clinic
Cleveland, Ohio, 44195
University of Maryland
College Park, Maryland, 20742
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Minnesota VA HealthCare System
Minneapolis, Minnesota, 55455
Temple University Hospital
Philadelphia, Pennsylvania, 19122
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
Official title: Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease (Tele-COPD)
The purpose of this study is to compare the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention.
Read the detailed description
This is a 52 week, prospective, randomized controlled, phase 3, multi-center clinical trial (n=768 at 14 clinical sites) comparing the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for COPD exacerbation to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention.
All patients with a clinical diagnosis of COPD who are hospitalized for an acute exacerbation of COPD at each clinical site will be considered for inclusion. Interested participants will be seen at 8 (-3 to +4) days after discharge from the hospital. At this visit, participants will be randomized 1:1, in varying blocks, stratified by site, to video telehealth PR plus standard of care versus standard of care alone. The telehealth intervention will involve 3 exercise sessions a week for 12 weeks. Exercise sessions will be provided in real-time via live two-way videoconferencing using a HIPAA-compliant app on an encrypted smart phone or similar device. Each session will be standardized to include cardiovascular (aerobic) training, strength (resistance) training, breathing exercises, and education that includes smoking cessation counselling where applicable, inhaler use techniques, diet, and nutrition. Participants in both the intervention and control arms will receive standard of care per local guidance. During the period of active intervention, participants in both arms will be contacted monthly to ascertain any exacerbations. Questionnaires and assessments of function will be administered at the baseline 8 day visit and at completion of the intervention at 13 weeks. Subsequently, participants in both arms will be called 3-monthly to ascertain healthcare utilization, and questionnaires and assessments of function will be repeated at the end of the follow-up period at 52 weeks.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Video Telehealth Pulmonary Rehabilitation
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Rehabilitation, Telehealth
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Telehealth Pulmonary RehabilitationBehavioural
Participant will be asked to exercise 3 times a week at their home for 60 minutes each session, via live two-way videoconferencing using a data-enabled smart phone or similar device. A total of 36 sessions will be administered over 13 weeks post-discharge. Sessions will be administered by exercise physiologists located at the University of Alabama at Birmingham. Each session will be scheduled with up to three other participants at a time to mimic group sessions as delivered at center-based pulmonary rehabilitation programs. Exercise sessions will include aerobics, strength or resistance training, breathing exercises, and education sessions. The exercise plans will be tailored according to the participants' baseline exercise tolerance as determined by an initial six minute walk test and their answers to the questionnaires at the baseline visit.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants will receive standard of care for COPD management per local guidance. In addition, they will receive 4-weekly phone calls for 13 weeks post discharge to inquire about health status and exacerbations. |
| Video Telehealth Pulmonary Rehabilitation | Active comparator | In addition to standard of care, participants will be asked to participate in rehabilitation sessions administered at home via live videoconferencing for approximately 60 minutes a session, three times a week. A total of 36 sessions will be planned to be completed by week 13 post-discharge. Exacerbations and health status will be ascertained every 4-weeks for 13 weeks. Receives: Behavioral: Video Telehealth Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation
Hospitalizations will be ascertained via weekly phone calls. Hospitalization for any reason will be considered a primary event when it occurs within the first 30 days after index hospitalization.
Measured: 30 days
Change in St. George's Respiratory Questionnaire
The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. It consists of 40 questions, and scores range from 0 to 100, with higher scores indicating worse quality of life. The minimum clinically important difference (MCID) is 4 units.
Measured: 13 weeks
Change in six-minute walk distance
The six-minute walk test is an assessment of functional capacity, and is the distance walked in 6 minutes. The minimum clinically important difference (MCID) for COPD is 26 m.
Measured: 13 weeks
Change in the University of California, San Diego Shortness of Breath Questionnaire
The University of California, San Diego Shortness of Breath Questionnaire (SOBQ) is a 24-question, self-administered questionnaire which rates dyspnea associated with activities of daily living. Scores range from 0 to 120, with higher scores indicating greater dyspnea. The minimum clinically important difference (MCID) is 5.
Measured: 13 weeks
Cost Savings
Cost saving will be estimated by comparing costs of the intervention and savings resulting from readmission reduction within 30 days.
Measured: 30 days
Cost per Quality Adjusted Life Year Gained
Cost-effectiveness will be calculated by comparing Telehealth PR with Standard of Care using incremental cost-effectiveness ratios.
Measured: 52 weeks
Secondary outcomes (9)
90-days all cause readmission rate
Hospitalizations will be ascertained by healthcare utilization questionnaire at the weekly phone calls.
Measured: 13 weeks
The adverse events (AEs) and serious adverse events (SAEs)
Safety of video telehealth PR intervention as determined by adverse events (AEs) and serious adverse events (SAEs)
Measured: 13 weeks
Change in COPD Assessment Test score
The COPD Assessment Test (CAT) survey is a validated, short (8-item) and simple patient completed questionnaire, and measures the health status of patients with COPD. This score is responsive to interventions such as pulmonary rehabilitation with a minimum clinically important difference (MCID) of 2 units.
Measured: 13 weeks
Change in 30-second Sit-to-Stand Test
The 30-second Sit-to-Stand test is an assessment of skeletal muscle dysfunction, leg strength and endurance. Scores range from 4 to 14, depending on age and sex, and higher scores indicate higher levels of functioning. The minimum clinically important difference (MCID) is 2.
Measured: 13 weeks
Change in the Clinical visit-PROactive Physical Activity Score
The Clinical visit-PROactive Physical Activity in COPD (C-PPAC) questionnaire will be used to generate scores for amount of physical activity, difficulty with physical activity and total physical activity experience. C-PPAC scores will be calculated by combining questionnaire items with two variables from activity monitors (steps/day and vector magnitude units (VMU)/min). Scores range from 0 to 100, where higher numbers indicate a better score. The minimum clinically important difference (MCID) is 6 for the amount and difficulty scores and 4 for the total score.
Measured: 13 weeks
Change in Pulmonary Rehabilitation Adapted Index of Self-Efficacy
The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool is a 15-item disease-specific questionnaire that measures pulmonary rehabilitation-specific self-efficacy. The score ranges from 15 to 60, with higher scores indicating high levels of self-efficacy. The minimum clinically important difference (MCID) is 1.5 units.
Measured: 13 weeks
Change in Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over a 1-month time interval. It has 7 components (sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction) that are each scored from 0 to 3 for a total PSQI score of 0 to 21, with higher scores indicating worse sleep quality. The minimum clinically important difference (MCID) is 3 units.
Measured: 13 weeks
Change in Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) will be used to measure symptoms of anxiety and depression. The HADS contains 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, with maximum scores of 21 for anxiety and depression. The minimum clinically important difference (MCID) is 1.5 units.
Measured: 13 weeks
Change in The modified Medical Research Council score
The modified Medical Research Council (mMRC) has 5 questions that assess dyspnea in a graded fashion and quantify symptoms in COPD. The minimum clinically important difference (MCID) is 0.7.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start28 Jun 2022
- Primary completion28 Feb 2026
- Study completion27 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 52 week, prospective, randomized controlled, phase 3, multi-center clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Surya P Bhatt, University of Alabama at Birmingham
- Investigators
- Surya P Bhatt, MD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119556
- Sponsor's protocol ID
- IRB-300008210
- Other IDs
- 1UG3HL155806-01A1
- Status last verified
- Apr 2026
- First submitted
- 26 Oct 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared through a password-protected website maintained without cost to researchers after requests are vetted by the principal investigators at UAB. The investigators will make the data and associated documentation available to users under a data sharing agreement that accounts for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Users must also agree to the conditions of use governing access to the public release of data, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. Research data will be de-identified to prevent disclosure of personal identifiers and presented in a summary format.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease (Tele-COPD)
- ClinicalTrials.gov ID
- NCT05119556
- Acronym / sponsor ID
- IRB-300008210
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Rehabilitation, Telehealth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 301 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 27 Feb 2028 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention.
Detailed description
This is a 52 week, prospective, randomized controlled, phase 3, multi-center clinical trial (n=768 at 14 clinical sites) comparing the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for COPD exacerbation to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention.
All patients with a clinical diagnosis of COPD who are hospitalized for an acute exacerbation of COPD at each clinical site will be considered for inclusion. Interested participants will be seen at 8 (-3 to +4) days after discharge from the hospital. At this visit, participants will be randomized 1:1, in varying blocks, stratified by site, to video telehealth PR plus standard of care versus standard of care alone. The telehealth intervention will involve 3 exercise sessions a week for 12 weeks. Exercise sessions will be provided in real-time via live two-way videoconferencing using a HIPAA-compliant app on an encrypted smart phone or similar device. Each session will be standardized to include cardiovascular (aerobic) training, strength (resistance) training, breathing exercises, and education that includes smoking cessation counselling where applicable, inhaler use techniques, diet, and nutrition. Participants in both the intervention and control arms will receive standard of care per local guidance. During the period of active intervention, participants in both arms will be contacted monthly to ascertain any exacerbations. Questionnaires and assessments of function will be administered at the baseline 8 day visit and at completion of the intervention at 13 weeks. Subsequently, participants in both arms will be called 3-monthly to ascertain healthcare utilization, and questionnaires and assessments of function will be repeated at the end of the follow-up period at 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 52 week, prospective, randomized controlled, phase 3, multi-center clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants will receive standard of care for COPD management per local guidance. In addition, they will receive 4-weekly phone calls for 13 weeks post discharge to inquire about health status and exacerbations. |
| Video Telehealth Pulmonary Rehabilitation | Active comparator | Behavioral: Video Telehealth Pulmonary RehabilitationIn addition to standard of care, participants will be asked to participate in rehabilitation sessions administered at home via live videoconferencing for approximately 60 minutes a session, three times a week. A total of 36 sessions will be planned to be completed by week 13 post-discharge. Exacerbations and health status will be ascertained every 4-weeks for 13 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40 or greater
- Clinical diagnosis of COPD
- Hospitalized for acute exacerbation of COPD.
- Be willing to adhere to trial and follow-up procedures and give informed consent
Key exclusion criteria (18 listed)
- Secondary diagnosis of congestive heart failure that is severe as documented by active symptoms, New York Heart Association (NYHA) functional classification IV or left ventricular ejection fraction <25% on echocardiography
- Other respiratory conditions that could confound the diagnosis such as asthma, pulmonary fibrosis, bronchiectasis, and lung cancer. Participants with pneumonic exacerbations of COPD will be included.
- Primary diagnosis of COVID pneumonia. Individuals with incidentally detected COVID or persistently positive for COVID but deemed to be convalescent will not be excluded.
- Active cancers on chemotherapy or radiation therapy
- Immunosuppressed states predisposing to frequent hospitalizations including uncontrolled HIV/AIDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Telehealth Pulmonary RehabilitationParticipant will be asked to exercise 3 times a week at their home for 60 minutes each session, via live two-way videoconferencing using a data-enabled smart phone or similar device. A total of 36 sessions will be administered over 13 weeks post-discharge. Sessions will be administered by exercise physiologists located at the University of Alabama at Birmingham. Each session will be scheduled with up to three other participants at a time to mimic group sessions as delivered at center-based pulmonary rehabilitation programs. Exercise sessions will include aerobics, strength or resistance training, breathing exercises, and education sessions. The exercise plans will be tailored according to the participants' baseline exercise tolerance as determined by an initial six minute walk test and their answers to the questionnaires at the baseline visit. | Behavioural | Video Telehealth Pulmonary Rehabilitation |
Primary outcome
All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation
Time frame: 30 days
Hospitalizations will be ascertained via weekly phone calls. Hospitalization for any reason will be considered a primary event when it occurs within the first 30 days after index hospitalization.
Change in St. George's Respiratory Questionnaire
Time frame: 13 weeks
The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. It consists of 40 questions, and scores range from 0 to 100, with higher scores indicating worse quality of life. The minimum clinically important difference (MCID) is 4 units.
Change in six-minute walk distance
Time frame: 13 weeks
The six-minute walk test is an assessment of functional capacity, and is the distance walked in 6 minutes. The minimum clinically important difference (MCID) for COPD is 26 m.
Change in the University of California, San Diego Shortness of Breath Questionnaire
Time frame: 13 weeks
The University of California, San Diego Shortness of Breath Questionnaire (SOBQ) is a 24-question, self-administered questionnaire which rates dyspnea associated with activities of daily living. Scores range from 0 to 120, with higher scores indicating greater dyspnea. The minimum clinically important difference (MCID) is 5.
Cost Savings
Time frame: 30 days
Cost saving will be estimated by comparing costs of the intervention and savings resulting from readmission reduction within 30 days.
Cost per Quality Adjusted Life Year Gained
Time frame: 52 weeks
Cost-effectiveness will be calculated by comparing Telehealth PR with Standard of Care using incremental cost-effectiveness ratios.
9 secondary outcomes
90-days all cause readmission rate
Time frame: 13 weeks
The adverse events (AEs) and serious adverse events (SAEs)
Time frame: 13 weeks
Change in COPD Assessment Test score
Time frame: 13 weeks
Change in 30-second Sit-to-Stand Test
Time frame: 13 weeks
Change in the Clinical visit-PROactive Physical Activity Score
Time frame: 13 weeks
Change in Pulmonary Rehabilitation Adapted Index of Self-Efficacy
Time frame: 13 weeks
Change in Pittsburgh Sleep Quality Index
Time frame: 13 weeks
Change in Hospital Anxiety and Depression Scale
Time frame: 13 weeks
Change in The modified Medical Research Council score
Time frame: 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared through a password-protected website maintained without cost to researchers after requests are vetted by the principal investigators at UAB. The investigators will make the data and associated documentation available to users under a data sharing agreement that accounts for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Users must also agree to the conditions of use governing access to the public release of data, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. Research data will be de-identified to prevent disclosure of personal identifiers and presented in a summary format.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surya P Bhatt, MD, MSPH principal investigator
University of Alabama at Birmingham
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Telehealth Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Alabama at Birmingham at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.