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NCT06156462
A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Adolescent and Adult Patients in an Emergency Department
trial testing ResAppDx v.20 in Asthma Exacerbation in 171 participants. Completed in 29 February 2024.
29 February 2024
Quick facts
| Lead sponsor | ResApp Health Limited |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 171 |
| Start date | 1 January 2024 |
| Primary completion | 29 February 2024 |
| Estimated completion | 29 February 2024 |
| Sites | 3 locations across United Kingdom |
Drugs / interventions tested
- ResAppDx v.20
Conditions studied
- Asthma Exacerbation — all drugs for Asthma Exacerbation →
- COPD Exacerbation — all drugs for COPD Exacerbation →
- Lower Respiratory Disease — all drugs for Lower Respiratory Disease →
- Pneumonia — all drugs for Pneumonia →
Sponsor
ResApp Health Limited
Who can join
12 and older, any sex, with Asthma Exacerbation or COPD Exacerbation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Aim is to to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of respiratory disease in the study's clinical setting compared to a clinical adjudication committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for respiratory disease diagnosis in an emergency department. Eligible subjects will be consented/enrolled and their subject reported signs/symptoms of respiratory disease will be recorded in the study electronic case report form (eCRF). The enrolled subject's cough sounds will be captured (5 cough sounds are required) using the ResAppDx v2.0 Investigational Device (ID) software installed on a study smartphone; cough sounds may be voluntary and/or involuntary/spontaneous. As this is an observational study the treating team will be blinded to the ResAppDx v2.0 diagnoses. Additional medical information will be collected from the treating team, from the subject and from the subject's medical record. No follow-up/subsequent visits with the subject will be required by the study. As an efficacy comparator, a clinical adjudication committee (CAC) will determine the final clinical diagnosis using the disease case definitions, eCRF data and the subject's medical record. Information on time and scope of tests and consults ordered by the treating team will be recorded to set a baseline for resource use and cost of current standard of care treatment/assessment procedures. This data will allow future health economics analyses to be performed. The blinded ResAppDx v2.0 diagnoses will be unblinded after database lock and sensitivity and specificity will be calculated for the ResAppDx v2.0 diagnoses compared to agreement with the CAC's final clinical diagnoses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06156462
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ResAppDx v.20
Trials testing the same drug.
- NCT06156436 — A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Paediatric Patients in an Emerg · completed
Other recruiting trials for Asthma Exacerbation
Currently open trials in the same condition.
- NCT07500532 — Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma · NA · recruiting
- NCT04480242 — Asthma Research in Children and Adolescents · active not recruiting
Other ResApp Health Limited trials
Trials by the same sponsor.
- NCT06156436 — A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Paediatric Patients in an Emerg · completed
- NCT04989452 — Cough Sound Recordings to Understand COVID-19-like Symptom Progression to Understand COVID-19-like Symptom Progression · unknown
- NCT04864535 — A Pilot Study for the Collection Of Vocalized, Individual Digital Cough Sound Recordings to Screen for COVID-19 · unknown
- NCT03392363 — Diagnosing Respiratory Disease in Children Using Cough Sounds 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06156462 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ResApp Health Limited
- Last refreshed: 4 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06156462.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing