Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers

Asthma Clinical Trial

Official title:

Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05304494
• Other study ID #: Sentinel - 001
• Status: Withdrawn
• Start date: March 2022
• Est. completion date: March 2024

Study information

• Verified date: March 2022
• Source: Sanome
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Asthma
• Asthma Chronic
• Breathlessness
• COPD
• Dyspnea
• Respiratory Sounds
• Shortness of Breath
• Wheezing

Intervention

Other:
• Biomarker tests for participant profiling
Combination of digital and physical tests to objectify measures relevant for breathlessness

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanome

References & Publications (5)

Barnes 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. — View Citation

Bossuyt 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. — View Citation

Coutinho 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. — View Citation

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. — View Citation

Tobin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day (One-time assessment during a participant reported episode of breathlessness)

External Links

•   Health Research Authority. Is my study research?
•   MHRA, Health and care research Wales, NHS Scotland, Health and Social Care & NHS Health Research Authority. Joint statement on seeking consent by electronic methods