Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers

Withdrawn

• Conditions: Asthma Chronic; COPD; Dyspnea; Asthma; Wheezing; Shortness of Breath; Breathlessness
• Interventions: Other: Biomarker tests for participant profiling

• Registration Number: NCT05304494
• Lead Sponsor: Sanome

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03
• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-03-31
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe Breathlessness	Biomarker tests for participant profiling	Breathlessness requiring admission or supplementary oxygen
Moderate Breathlessness	Biomarker tests for participant profiling	Breathlessness requiring medical intervention \< 24 hours without meeting the criteria for severe breathlessness
Mild Breathlessness	Biomarker tests for participant profiling	Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan

Primary Outcome Measures

Name	Time	Method
Physician assessed severity of breathlessness	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