Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-31

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biomarker Assay Validation in Healthy Smokers and COPD Smokers and Ex-smokers

NCT02490358

COPD Asthma

COMPLETED

Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath

NCT06528418

Lung Cancer Lung Infection COPD +13 more

RECRUITING

Novel Biomarkers in Chronic Airway Diseases

NCT00849836

Asthma COPD

UNKNOWN

Asthma Breath Biomarker Assessment

NCT03084016

Asthma Acute

COMPLETED

Respiratory Pathogens of Patients With Asthma and COPD Exacerbations

NCT02866357

COPD

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breathlessness COPD Asthma Asthma Chronic Wheezing Dyspnea Shortness of Breath

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Severe Breathlessness

Breathlessness requiring admission or supplementary oxygen

Biomarker tests for participant profiling

Intervention Type OTHER

Combination of digital and physical tests to objectify measures relevant for breathlessness

Moderate Breathlessness

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

Biomarker tests for participant profiling

Intervention Type OTHER

Combination of digital and physical tests to objectify measures relevant for breathlessness

Mild Breathlessness

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

Biomarker tests for participant profiling

Intervention Type OTHER

Combination of digital and physical tests to objectify measures relevant for breathlessness

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biomarker tests for participant profiling

Combination of digital and physical tests to objectify measures relevant for breathlessness

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No