Asthma Respiratory Asthma
Conditions
Interventions
The ABRS study will be carried out in 3 different cohorts
adults at Queen Alexandra Hospital, Adults in Primary care in Oxford, and Children at Queen Alexandra Hospital. The aim is to gain information about the changes in the CO2 waveform before, during and
Sponsors
Cambridge Respiratory Innovations Limited
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TBCO2 waveform parameters before an asthma exacerbation measured using the N Tidal C Device | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Asthma - severity measured by BTS Stage 2-5 (adult cohort -baseline, 3 months, 6 months, 9 months and 12 months) (paediatric cohort - baseline, 3 months, 6 months) 2. Disease Control - measured by asthma control questionnaire (adult cohort -baseline, 3 months, 6 months, 9 months and 12 months) (paediatric cohort - baseline, 3 months, 6 months) 3. Quality of life - measured by Asthma quality of life questionnaire(adult cohort -baseline, 3 months, 6 months, 9 months and 12 months) (paediatric cohort - baseline, 3 months, 6 months) 4. Lung Function – measured by spirometry (adult cohort -baseline, 3 months, 6 months, 9 months and 12 months) (paediatric cohort - baseline, 3 months, 6 months) 5. Airway Inflammation measured by fractional exhaled Nitric Oxide (FeNO) (adult cohort -baseline, 3 months, 6 months, 9 months and 12 months) (paediatric cohort - baseline, 3 months, 6 months) 6. Airway resistance – measured by Airway Oscillometry (adult cohort – baseline and 12 months, paediatric cohort baseline and 6 months) | — |
Countries
England, United Kingdom
Outcome results
None listed