Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers

Sanome

Status: Withdrawn

Conditions: Wheezing; Asthma; Dyspnea; Shortness of Breath; Asthma Chronic; COPD; Breathlessness

Treatments: Other: Biomarker tests for participant profiling

Study type: Observational

Funder types: Industry

Identifiers

NCT05304494

Sentinel - 001

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 3 patient groups

Severe Breathlessness

Description:

Breathlessness requiring admission or supplementary oxygen

Treatment:

Other: Biomarker tests for participant profiling

Moderate Breathlessness

Description:

Breathlessness requiring medical intervention \< 24 hours without meeting the criteria for severe breathlessness

Treatment:

Other: Biomarker tests for participant profiling

Mild Breathlessness

Description:

Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan

Treatment:

Other: Biomarker tests for participant profiling