Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders
Conditions
Interventions
Participants are randomised to one of two groups using a computer generated sequence.
Group A: Participants have their inhaler usage monitored but have no feedback on this.
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65 inclusive 2. Use of systemic corticosteroids for worsening asthma (or an increase from baseline dose in patients on long-term oral corticosteroids) in the prior 12 months (i.e. at least one asthma exacerbation requiring additional systemic corticosteroid in the prior 12 months) patient reported 3. Doctor’s diagnosis of asthma for at least 12 months 4. On BTS step 2-5 treatment via MDI 5. Use of own internet-enabled and compatible mobile phone 6. Participant is willing and able to give informed consent for participation in the clinical investigation 7. Able (in the Investigators opinion) and willing to comply with all clinical investigation requirements 8. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the clinical investigation
Exclusion criteria
Exclusion criteria: 1. Diagnosis of COPD or onset of symptoms after the age of 40 in patients with =10 PYH of smoking 2. Other clinically significant coexisting respiratory disease e.g. fibrosis, bronchiectasis 3. No personal mobile smartphone 4. Patients on maintenance and reliever therapy (Symbicort ‘SMART’ or Fostair 'MART’) 5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the clinical investigation, or may influence the result of the clinical investigation, or the participant’s ability to participate in the clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Preventer use: The mean percentage of prescribed doses taken daily over the study period is assessed using electronic monitoring device data at Week 24 2. Reliever Use: The number of days with >16 actuations/day of Salbutamol taken in a 24-hour period is assessed using electronic monitoring device data at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication use (Categorised by preventer and reliever medication): 1. Number of days of preventer non-adherence (0 actuations per 24 hours), expressed as a rate: number of days/days of treatment, is measured by electronic monitoring device at Week 24 2. Number of days of 100% preventer adherence (when all prescribed doses taken) is measured by electronic monitoring device Week 24 3. Mean % of prescribed preventer dose taken daily is assessed by electronic monitoring device every month for 6 months 4. Number of days of overuse of preventer treatment (when more than daily prescribed doses taken i.e. >2 or >4/day) is measured by electronic monitoring device at Week 24 5. Mean daily ICS (preventer) dose is assessed by dividing the total number of actuations over study period multiplied by dose per actuation by the number of days of treatment exposure, at Week 24 6. Overuse of SABA (reliever): Number of days of >24 and >32 actuations of salbutamol in a 24 hour period, is measured by electronic monitoring device at Week 24 7. Number of days of zero SABA use (reliever) is measured by electronic monitoring device at Week 24 Clinical control: 1. Number of exacerbations (treatment with systemic corticosteroids for asthma or antibiotics) is measured by electronic monitoring device at weeks 4, 8, 12, 16, 20 and 24 (final visit) 2. FEV1 is measured using spirometry at baseline (Week 0) and final visit (Week 24) 3. Subjective asthma control is measured using the Asthma Control Test (ACT) at baseline (week 0), weeks 4, 8, 12, 16, 20 and 24 (final visit) Secondary outcomes: treatment decisions: 1. Patient views/attitudes to monitoring/ feedback are assessed using patient interviews at the final study visit 2. Understand patient factors around using devices are | — |
Countries
England, United Kingdom
Outcome results
None listed