ISRCTN60465402
Active, not recruiting
Phase 4
A longitudinal, observational study to explore the Tidal Breathing Carbon Dioxide (TBCO2) waveform, measured using the N-Tidal C device, in asthma
Cambridge Respiratory Innovations Limited0 sites140 target enrollmentFebruary 28, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cambridge Respiratory Innovations Limited
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or Female, aged \> \= 7 years
- •2\. 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
- •3\. Moderate or Severe asthma (defined as BTS stage 2\-5\)
- •4\. Poorly controlled asthma (defined as an ACQ score of \> \= 1\)
- •5\. Exacerbation prone asthma (defined as at least 1 asthma exacerbation requiring oral corticosteroid treatment in the last 12 months)
- •6\. Providing written informed consent, or parental/guardian consent and participant assent in the case of a child
Exclusion Criteria
- •1\. Inability to understand or comply with study procedures and/or inability to give fully informed consent
- •2\. 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)
- •3\. Smokers (current or ex\-smokers) with a \> 10 pack\-year history
- •4\. 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
Outcomes
Primary Outcomes
Not specified
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