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| ID | Type | Description | Link |
|---|---|---|---|
| 37872 | Other Identifier | ISRCTN |
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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| Portsmouth Hospitals NHS Trust | OTHER_GOV |
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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.
People with more severe asthma suffer from frequent asthma attacks that require regular hospital admissions. These attacks are difficult to predict and can devastate the lives of patients. A new tool is needed that can help to predict when an asthma attack is going to happen. This would help people recognise an attack earlier and allow treatment to be started sooner. This study will evaluate a new breathing monitor, to see whether it can detect asthma attacks. The study tests a new device, called 'N-Tidal C', which uses a method that has the potential to predict when attacks are about to happen. The investigators have found that people with asthma breathe out a gas, called carbon dioxide (CO2), in a different way to healthy people. The pattern of breathing out CO2 (the waveform) changes further when patients are having an attack of their disease. If patients could monitor their CO2, they may recognise when their asthma is getting worse, and take earlier action to avoid attacks getting out of hand and going to hospital.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control in asthma patients | Asthma Control Questionnaire (ACQ) (0= no impairment 6 = maximum impairment) | From baseline until study completion, up to 12 months. |
| Quality of Life | Asthma Quality of Life Questionnaire (AQLQ) 7 = not impaired at all - 1 = severely impaired |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with poorly controlled asthma
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| Name | Affiliation | Role |
|---|---|---|
| Anoop Chauhan | Portsmouth Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portsmouth Hospitals NHS Trust | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37268935 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| From baseline until study completion, up to 12 months. |
| Usability and Acceptability of the device | Visual Analogue Scale (VAS) (7=easy to use - 28=difficult to use) | From baseline until study completion, up to 12 months. |
| Impact on work activity of the device within asthma population | Work Productivity and Activity Impairment Questionnaire (WPAI): Asthma (1=employed - 5= health affected productivity while working) | From baseline until study completion, up to 12 months. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |