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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03356288
Other study ID # G002-17_GBRS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 9, 2017
Est. completion date July 4, 2018

Study information

Verified date September 2018
Source Cambridge Respiratory Innovations Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness. It will also evaluate whether this device can detect when a person's breathing problem is getting worse.


Description:

When a person breathes out, they exhale carbon dioxide (CO2). The CO2 levels in breath change as they breathe out and this makes a specific pattern, or "waveform". This waveform can tell a clinician a lot about the underlying health of a person. There are disease specific CO2 waveforms for common breathing conditions such as Asthma and Chronic Obstructive Pulmonary Disease (COPD). However up until this point there has been no accurate and non-invasive method of measuring the tidal breath CO2 waveform.

This study will test the N-Tidal C, a new handheld device that accurately measures this waveform, and whether it can differentiate different causes of breathlessness; namely asthma, heart failure, pneumonia, breathing pattern disorders and motor neurone disease.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date July 4, 2018
Est. primary completion date July 4, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

Asthma Cohort:

- A confirmed clinical diagnosis of asthma for = 6months

- Moderate to severe asthma defined as British Thoracic Society stages 3-5

- 2 or more exacerbations in the previous 12 months with at least 1 exacerbation within the last 6 months.

- Exacerbation free for 2 weeks (defined as no increased dose or course of oral corticosteroids or antibiotics).

Breathing Pattern Disorder Cohort

- A Clinical diagnosis of a Breathing Pattern Disorder (BPD)

Chronic heart failure Cohort:

- A confirmed clinical diagnosis of chronic heart failure with both of the following:

1. A Left Ventricular Ejection Fraction <40% on most recent imaging within the last 12 months.

2. New York Heart Association Class 2-4

- Admitted with an acute decompensation of their heart failure to hospital within the last 6 months

Motor Neurone Disease Cohort:

- A confirmed clinical diagnosis of Motor Neurone Disease

- Forced Vital Capacity (FVC) of less than 60% of predicted, sleep disordered breathing or daytime hypercapnia.

- Established on Home Non-Invasive Ventilation.

Pneumonia Cohort:

- A confirmed clinical diagnosis of Pneumonia supported by evidence of consolidation on a chest X-ray (CXR) or computed tomography (CT) imaging.

Healthy Cohort:

- No known history of lung, cardiac or neuromuscular disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung, cardiac or neuromuscular disease). A Body Mass Index of less than 40. A Non-smoker, or an ex-smoker with less than a 5 pack year history.

Exclusion Criteria:

- Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would affect spirometry and/or other measures of lung function or Tidal Breath Carbon Dioxide measurements.

- In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently over the course of 6 months.

Study Design


Locations

Country Name City State
United Kingdom Portsmouth Hospitals NHS Trust Portsmouth Hampshire

Sponsors (2)

Lead Sponsor Collaborator
Cambridge Respiratory Innovations Limited Innovate UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The tidal breathing carbon dioxide waveform for each of the breathing conditions as measured by the N-Tidal C device 12 months
Secondary Change in the Tidal Breathing carbon dioxide waveform over time Change in the tidal breathing carbon dioxide waveform, in each disease, over the 6 months. Change measures - baseline to 6 months
Secondary Disease Control in asthma patients The Asthma Control Questionnaire Score for the Asthma patients 12 months
Secondary Disease Improvement in Breathing Pattern Disorder patients The Nijmegen Questionnaire Score 12 months
Secondary Disease severity in the pneumonia patients The CURB-65 Score 2 days
Secondary Disease severity in heart failure patients The Trans Thoracic Echocardiogram (TTE) result 12 months
Secondary Hypercapnia in the motor neurone disease patients The level of partial pressure carbon dioxide (pCO2) 12 months
Secondary Usability of the N-Tidal C device Measured by how frequently the patients remember to use the N-Tidal C device over 6 months Change measures - baseline to 6 months
Secondary Acceptability of the N-Tidal C device Measured by a questionnaire of the participants experience of the device at the end of the study 12 months
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