NCT04504838

Brief Summary

The study involves a new device, called 'N-Tidal C', which uses a method that has the potential to predict when asthma attacks are about to happen. The device works by accurately measuring an individual's exhaled CO2 waveform. A person has to breathe in and out through the mouthpiece at their normal relaxed rate of breathing. It does not need any extra effort and therefore has considerable benefits over current breathing tests which require significant patient effort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

April 8, 2020

Last Update Submit

June 16, 2022

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Tidal Breathing Carbon Dioxide (TBCO2) breath records measured by the N-Tidal C data collector device.

    To collect Tidal Breathing Carbon Dioxide (TBCO2) breath records, twice daily per participant, which will be correlated to patient reported outcomes and clinical assessments.

    From baseline until study completion, up to 12 months.

Secondary Outcomes (4)

  • Disease Control in asthma patients

    From baseline until study completion, up to 12 months.

  • Quality of Life

    From baseline until study completion, up to 12 months.

  • Usability and Acceptability of the device

    From baseline until study completion, up to 12 months.

  • Impact on work activity of the device within asthma population

    From baseline until study completion, up to 12 months.

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with poorly controlled asthma

You may qualify if:

  • Male or Female, aged ≥7 years.
  • Confirmed clinician diagnosis of asthma by examination of medical records, and based on accepted national and/or international criteria e.g. BTS/SIGN, or GINA.
  • Moderate or Severe asthma (defined as BTS stage 2-5)
  • Poorly controlled asthma (defined as an ACQ score of ≥1)
  • Exacerbation prone asthma (defined as at least 1 asthma exacerbation requiring oral corticosteroid treatment in the last 12 months).
  • Providing written informed consent, or parental/guardian consent and participant assent in the case of a child

You may not qualify if:

  • Inability to understand or comply with study procedures and/or inability to give fully informed consent.
  • Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would affect spirometry and/or other measures of lung function or TBCO2 measurements (including Breathing Pattern Disorder or Chronic Obstructive Pulmonary Disease).
  • Smokers (current or ex-smokers) with a \>10 pack year history.
  • In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently (for example, difficulty holding the device, or long periods of absence/travel) throughout the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Related Publications (1)

  • Talker L, Neville D, Wiffen L, Selim AB, Haines M, Carter JC, Broomfield H, Lim RH, Lambert G; BRS Study Team; Weiss ST, Hayward G, Brown T, Chauhan A, Patel AX. Machine diagnosis of chronic obstructive pulmonary disease using a novel fast-response capnometer. Respir Res. 2023 Jun 2;24(1):150. doi: 10.1186/s12931-023-02460-z.

    PMID: 37268935DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Anoop Chauhan

    Portsmouth Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2020

First Posted

August 7, 2020

Study Start

February 11, 2020

Primary Completion

January 20, 2022

Study Completion

January 31, 2022

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)