Status:
COMPLETED
The Asthma Breathing Record Study
Lead Sponsor:
TidalSense
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Portsmouth Hospitals NHS Trust
Conditions:
Asthma
Eligibility:
All Genders
7+ years
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 individu...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04504838
Start Date
February 11 2020
End Date
January 31 2022
Last Update
June 21 2022
Active Locations (1)
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1
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY