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NCT03615365: CBRS2

COPD Breathing Record Study 2

Completed Last updated 2 June 2023
What this trial tests

trial in Chronic Obstructive Pulmonary Disease in 50 participants. Completed in 23 November 2018.

Timeline
15 August 2017
Primary endpoint
18 October 2018
23 November 2018

Quick facts

Lead sponsorTidalSense
StatusCompleted
Study typeOBSERVATIONAL
Enrollment50
Start date15 August 2017
Primary completion18 October 2018
Estimated completion23 November 2018
Sites1 location across United Kingdom

Conditions studied

Sponsor

TidalSense

Who can join

40 and older, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to collect capnometric (tidal breathing CO2) data using TidalSense's N-Tidal C Data Collector Device. The data collected will be examined for correlation with currently accepted assessment techniques for COPD (spirometry, vital signs and pulse oximetry) and the patient's clinical condition (stable, worsening, improving). The patient numbers and study duration have been determined by power calculations to provide a statistically significant sample size, based on expected number of exacerbations (mild, moderate and severe) from the patient cohort. The data will also be examined to assess the predictive possibility of a non-invasive self-care personal CO2 monitoring device to identify COPD exacerbations.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Machine diagnosis of chronic obstructive pulmonary disease using a novel fast-response capnometer.
    Talker L, Neville D, Wiffen L, Selim AB, et al · · 2023 · cited 2× · PMID 37268935 · DOI 10.1186/s12931-023-02460-z
  2. Quantification of smoking-related airway remodelling in COPD, using N-Tidal.
    Lim RH, Talker L, Broomfield H, Dogan C, et al · · 2026 · PMID 41748706 · DOI 10.1038/s41598-026-41699-6
  3. Diagnosis and Severity Assessment of COPD using a Novel Fast-Response Capnometer And Interpretable Machine Learning
    Talker L, Dogan C, Neville D, Lim RH, et al · · 2023 · DOI 10.1101/2023.12.20.23300327

Verify or expand the search:

Other recruiting trials for Chronic Obstructive Pulmonary Disease

Currently open trials in the same condition.

Other TidalSense trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03615365.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing