Severe asthma Respiratory Asthma
Conditions
Interventions
Current interventions as of 26/02/2020:
This feasibility project uses the Medical Research Council (MRC) guidelines on developing a complex intervention. It will have four stages and a
recruiting 40 patients to the AT-PR programme, the precision of the estimated retention rate would be at least +/- 14%. From experience to date, we are expecting very few serious adverse events relati
Sponsors
University Hospitals of Leicester NHS Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Patients with severe asthma (defined as asthma which remains symptomatic at steps 4-5 of the British Thoracic Society asthma guidelines), despite management for >6 months in the Glenfield Difficult Asthma Clinic (DAC), will be recruited. All patients will have a thorough diagnostic work up and a treatment strategy targeting eosinophillic airway inflammation to optimise control; exercise-induced asthma is often a reflection of poor control.
Exclusion criteria
Exclusion criteria: 1. Severe exacerbation within a month of entry 2. Inability to exercise e.g. due to significant musculoskeletal or neurological abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the practicality of a definitive multicentre RCT, the primary outcomes for the feasibility study are: 1. Recruitment rate 2. Retention rate 3. Incidence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| The outcome measures proposed for the multicentre trial will be included to assess patient acceptability of the tests, study protocol and data completion. The outcome measures to assess the intervention will be collected at baseline, 12 weeks and 6 months by a blinded investigator. We have experience in using all proposed outcome measures. Baseline demographics will be recorded including body mass index and spirometry. Safety 1. Any adverse events directly or indirectly related to the exercise measurements and training sessions will be recorded. Any severe adverse event will be reported to our Research and Development office immediately. An external respiratory physician has agreed to independently assess any adverse events and stop the trial if necessary. 2. A full cardiopulmonary exercise test with expiratory gas analysis will be performed on a treadmill. Exercise-induced bronchoconstriction will be assessed by a flow-volume loop, before and after the treadmill test, before and after 12 weeks. All patients will be included in the programme and excluded only if they have an adverse event. This data will used as an outcome measure not just for safety. 3. Asthma control and disease activity will be assessed by: 3.1. The Juniper Asthma Control Score 3.2. Measuring airway inflammation by induced sputum count before and after the intervention 3.3. By comparing the preceeding 9 months unscheduled healthcare visits for asthma with 9 months after and including the intervention, including GP, accident and emergency attendance and hospital admissions. Cost effectiveness The Euroqol (EQ-5D) questionnaire will be used to assess quality-adjusted life-years (QALYs) at baseline, 12 weeks and 6 months. Costs will be calculated using NHS tariffs. All treatment including medication, adverse events and any over the counter medication will b | — |
Countries
United Kingdom
Outcome results
None listed