COPDNCT03531489
Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients
A study testing AIR-AD in people with COPD and Chronic Obstructive Pulmonary Disease, run by Right-Air at 1 site in United States.
Trial summary
The study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. The study population will consist of severe Chronic Obstructive Pulmonary Disease (COPD) subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- AIR-AD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Moderate to severe COPD (by ATS criteria)
- FEV1/FVC <0.70
- FEV1 < 60% Predicted
Who cannot join
- Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc…)
- Lung pathology not explained by COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc…)
- Pregnancy
- Age <18
Trial locations and contacts
1 site in 1 country.
Perry Dubin, MD/MPH contact
United States1 site, 1 recruiting
- Recruiting
John Hansen-Flaschen
Philadelphia, Pennsylvania, 19104
Maria Escobar, 215-349-5023, escobarm@pennmedicine.upenn.edu
About this study
Official title: Pilot, Single Center Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients
The study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. The study population will consist of severe Chronic Obstructive Pulmonary Disease (COPD) subjects.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Being tested
- AIR-AD
- 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.
AIR-ADDevice
Non-significant risk medical device as decided by institutional review board
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Feasibility | Experimental | Patients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback. Receives: Device: AIR-AD |
| Part 2: Crossover | Experimental | Crossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it. Receives: Device: AIR-AD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess distance travelled during 6-minute walk tests performed with and without device.
Distances travelled during two six minute walk tests will be measured. Investigator will compare distance travelled with use of the device to the distance travelled without the use of the device.
Measured: 6 months
Secondary outcomes (1)
Assess for patient improvement in shortness of breath scores
This will be be measured via survey tool Borg Scale of Dyspnea (0 - no dyspnea, through 10 - maximal dyspnea). Patient scores will be measured during exercise testing with and without the device. Improvement will be considered a lower score on the Borg Scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start26 Apr 2018
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Right-Air
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- John Hansen-Flaschen, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531489
- Sponsor's protocol ID
- Penn 826372
- Status last verified
- May 2018
- First submitted
- 16 Apr 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Single Center Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT03531489
- Acronym / sponsor ID
- Penn 826372
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Right-AirIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 21 May 2018 (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 study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. The study population will consist of severe Chronic Obstructive Pulmonary Disease (COPD) subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Feasibility | Experimental | Device: AIR-ADPatients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback. |
| Part 2: Crossover | Experimental | Device: AIR-ADCrossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Moderate to severe COPD (by ATS criteria)
- FEV1/FVC <0.70
- FEV1 < 60% Predicted
Key exclusion criteria (4 listed)
- Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc…)
- Lung pathology not explained by COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc…)
- Pregnancy
- Age <18
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 |
|---|---|---|
| AIR-ADNon-significant risk medical device as decided by institutional review board | Device | Part 1: Feasibility, Part 2: Crossover |
Primary outcome
Assess distance travelled during 6-minute walk tests performed with and without device.
Time frame: 6 months
Distances travelled during two six minute walk tests will be measured. Investigator will compare distance travelled with use of the device to the distance travelled without the use of the device.
1 secondary outcome
Assess for patient improvement in shortness of breath scores
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Individual participant dataSharing planned: No
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Perry Dubin, MD/MPH contact
John Hansen-Flaschen, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIR-AD in people with COPD and Chronic Obstructive Pulmonary Disease, run by Right-Air at 1 site 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Escobar (215-349-5023, escobarm@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess distance travelled during 6-minute walk tests performed with and without device. (time frame: 6 months). 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 21 May 2018.