BreathlessnessNCT05304494
Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers
An observational study of Breathlessness and COPD, run by Sanome.
Trial summary
The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Breathlessness, COPD, Asthma
- What is being tested?
- Biomarker tests for participant profiling
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Mar 2024
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants having experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional.
Who may be able to join
- Aged 18-90 years.
- Has experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional. Self-reported breathlessness using any of the following words to describe symptoms will qualify as a presentation of breathlessness regardless of aetiology or severity of symptoms: shortness of breath, tight chest, trouble breathing, breathlessness, dyspnoeic, breathless, asthmatic, suffocating, wheezing, fighting for breath or any equivalent word. Breathlessness does not have to be the primary presenting symptom.
- Deemed clinically sufficiently stable to participate according to health care practitioner.
Who cannot join
- Inability to understand written local language at a year 5 level.
- Not being confident in use of digital technology (smartphone and/or tablet). This will become evident through an inability to use the system.
- Inability to enter required study sample data due to diminished consciousness and/or physical or mental capacity regardless of whether this is associated with the breathlessness event.
- Received an investigational medical product in the context of a Clinical Trial during the 28 days prior to first probe administration.
About this study
The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.
- Conditions
- Breathlessness, COPD, Asthma, Asthma Chronic, Wheezing, Dyspnea
- Being tested
- Biomarker tests for participant profiling
- Keywords
- Breathlessness, COPD, Asthma, Asthma Chronic, Wheezing, Dyspnea, Shortness of Breath
- Medical subject headings
- Dyspnea, Pulmonary Disease, Chronic Obstructive, Asthma, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker tests for participant profilingOther
Combination of digital and physical tests to objectify measures relevant for breathlessness
| Study group | Role | What they receive |
|---|---|---|
| Severe Breathlessness | Breathlessness requiring admission or supplementary oxygen Receives: Other: Biomarker tests for participant profiling | |
| Moderate Breathlessness | Breathlessness requiring medical intervention < 24 hours without meeting the criteria for severe breathlessness Receives: Other: Biomarker tests for participant profiling | |
| Mild Breathlessness | Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan Receives: Other: Biomarker tests for participant profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician assessed severity of breathlessness
Breathlessness requiring admission or supplementary oxygen, breathlessness requiring intervention < 24 hours, Breathlessness requiring medical intervention within 24 hours without meeting the criteria for severe breathlessness, Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan
Measured: 1 day (One-time assessment during a participant reported episode of breathlessness)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: Limited resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BreathlessnessStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304494
- Sponsor's protocol ID
- Sentinel - 001
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Smith AK, Currow DC, Abernethy AP, Johnson MJ, Miao Y, Boscardin WJ, Ritchie CS. Prevalence and Outcomes of Breathlessness in Older Adults: A National Population Study. J Am Geriatr Soc. 2016 Oct;64(10):2035-2041. doi: 10.1111/jgs.14313. Epub 2016 Sep 7.
PubMed 27603500Tobin MJ, Laghi F, Jubran A. Why COVID-19 Silent Hypoxemia Is Baffling to Physicians. Am J Respir Crit Care Med. 2020 Aug 1;202(3):356-360. doi: 10.1164/rccm.202006-2157CP.
PubMed 32539537Barnes N, Calverley PM, Kaplan A, Rabe KF. Chronic obstructive pulmonary disease and exacerbations: patient insights from the global Hidden Depths of COPD survey. BMC Pulm Med. 2013 Aug 23;13:54. doi: 10.1186/1471-2466-13-54.
PubMed 23971625Coutinho AD, Lokhandwala T, Boggs RL, Dalal AA, Landsman-Blumberg PB, Priest J, Stempel DA. Prompt initiation of maintenance treatment following a COPD exacerbation: outcomes in a large insured population. Int J Chron Obstruct Pulmon Dis. 2016 Jun 8;11:1223-31. doi: 10.2147/COPD.S102570. eCollection 2016.
PubMed 27354781Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG; Standards for Reporting of Diagnostic Accuracy. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med. 2003 Jan 7;138(1):W1-12. doi: 10.7326/0003-4819-138-1-200301070-00012-w1.
PubMed 12513067
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers
- ClinicalTrials.gov ID
- NCT05304494
- Acronym / sponsor ID
- Sentinel - 001
- Conditions
- Breathlessness, COPD, Asthma, Asthma Chronic, Wheezing, Dyspnea
- Keywords
- Breathlessness, COPD, Asthma, Asthma Chronic, Wheezing, Dyspnea, Shortness of Breath
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Limited resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SanomeIndustry (pharma, biotech, devices)
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 31 Mar 2022 (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 Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe Breathlessness | – | Other: Biomarker tests for participant profilingBreathlessness requiring admission or supplementary oxygen |
| Moderate Breathlessness | – | Other: Biomarker tests for participant profilingBreathlessness requiring medical intervention < 24 hours without meeting the criteria for severe breathlessness |
| Mild Breathlessness | – | Other: Biomarker tests for participant profilingBreathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants having experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional.
Key inclusion criteria (3 listed)
- Aged 18-90 years.
- Has experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional. Self-reported breathlessness using any of the following words to describe symptoms will qualify as a presentation of breathlessness regardless of aetiology or severity of symptoms: shortness of breath, tight chest, trouble breathing, breathlessness, dyspnoeic, breathless, asthmatic, suffocating, wheezing, fighting for breath or any equivalent word. Breathlessness does not have to be the primary presenting symptom.
- Deemed clinically sufficiently stable to participate according to health care practitioner.
Key exclusion criteria (4 listed)
- Inability to understand written local language at a year 5 level.
- Not being confident in use of digital technology (smartphone and/or tablet). This will become evident through an inability to use the system.
- Inability to enter required study sample data due to diminished consciousness and/or physical or mental capacity regardless of whether this is associated with the breathlessness event.
- Received an investigational medical product in the context of a Clinical Trial during the 28 days prior to first probe administration.
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 |
|---|---|---|
| Biomarker tests for participant profilingCombination of digital and physical tests to objectify measures relevant for breathlessness | Other | Mild Breathlessness, Moderate Breathlessness, Severe Breathlessness |
Primary outcome
Physician assessed severity of breathlessness
Time frame: 1 day (One-time assessment during a participant reported episode of breathlessness)
Breathlessness requiring admission or supplementary oxygen, breathlessness requiring intervention < 24 hours, Breathlessness requiring medical intervention within 24 hours without meeting the criteria for severe breathlessness, Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Background: PubMed 27603500Smith AK, Currow DC, Abernethy AP, Johnson MJ, Miao Y, Boscardin WJ, Ritchie CS. Prevalence and Outcomes of Breathlessness in Older Adults: A National Population Study. J Am Geriatr Soc. 2016 Oct;64(10):2035-2041. doi: 10.1111/jgs.14313. Epub 2016 Sep 7.
- Background: PubMed 32539537Tobin MJ, Laghi F, Jubran A. Why COVID-19 Silent Hypoxemia Is Baffling to Physicians. Am J Respir Crit Care Med. 2020 Aug 1;202(3):356-360. doi: 10.1164/rccm.202006-2157CP.
- Background: PubMed 23971625Barnes N, Calverley PM, Kaplan A, Rabe KF. Chronic obstructive pulmonary disease and exacerbations: patient insights from the global Hidden Depths of COPD survey. BMC Pulm Med. 2013 Aug 23;13:54. doi: 10.1186/1471-2466-13-54.
- Background: PubMed 27354781Coutinho AD, Lokhandwala T, Boggs RL, Dalal AA, Landsman-Blumberg PB, Priest J, Stempel DA. Prompt initiation of maintenance treatment following a COPD exacerbation: outcomes in a large insured population. Int J Chron Obstruct Pulmon Dis. 2016 Jun 8;11:1223-31. doi: 10.2147/COPD.S102570. eCollection 2016.
- Background: PubMed 12513067Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG; Standards for Reporting of Diagnostic Accuracy. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med. 2003 Jan 7;138(1):W1-12. doi: 10.7326/0003-4819-138-1-200301070-00012-w1.
- Health Research Authority. Is my study research?Link provided by the sponsor.
- MHRA, Health and care research Wales, NHS Scotland, Health and Social Care \& NHS Health Research Authority. Joint statement on seeking consent by electronic methodsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breathlessness and COPD, run by Sanome.
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: withdrawn, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Physician assessed severity of breathlessness (time frame: 1 day (One-time assessment during a participant reported episode of breathlessness)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05304494, which also lists 5 linked publications.
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 May 2022.