Asthma Respiratory
Conditions
Interventions
The main aim of the study is to assess the feasibility and acceptability of a future study evaluating the clinical and cost-effectiveness of the Find Air One add-on inhaler devices and smartphone app
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Identified at admission to Wythenshawe Hospital A&E, respiratory wards, or referral to general asthma clinic 2. Male and female patients =18 years 3. A physician diagnosis of mild to moderate asthma for at least one year prior to screening 4. Prescribed an ICS or ICS/LABA which is compatible with the FindAIR digital inhaler monitors 5. =1 asthma exacerbation requiring oral steroids in the past 12 months 6. Non-smoker or ex-smoker, defined as someone who completely stopped smoking cigarettes (including e-cigarettes) for at least 12 months prior to screening and with a smoking history of less than 5-pack years 7. Confirmed diagnosis of asthma as documented evidence of one of the following: 7.1 Blood eosinophils above the laboratory reference range. 7.2 Forced exhaled nitric oxide (FeNO) above 50 parts per billion (ppb) 7.3 Bronchial hyperresponsiveness assessed as documented evidence of variable expiratory airflow limitation at screening or in the past 2 years prior to screening, defined as one of the following: 7.3.1.=12% or =200 ml improvement in FEV1 in a bronchodilator reversibility test 7.3.2. Provocative dose or concentration of methacholine resulting in a =20% drop in FEV1 (PD20 or PC20, respectively) of =1 mg or =16 mg/ml, respectively
Exclusion criteria
Exclusion criteria: 1. Inability to comply with study procedures, required restrictions, study treatment intake or any other reason that the Investigator considers makes the subject unsuitable to participate 2. Requires oxygen therapy, even on an occasional basis 3. Known respiratory disorders other than asthma according to the investigator’s judgement. 4. A diagnosis of severe asthma. 5. Participation in another clinical trial and received investigational drug within 30 days (or 5 half-lives whichever is longer) prior to screening. N.B.: For biologic products with slow elimination a washout of at least 6 months needs to be met prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of a future definitive trial: 1. The effect size for future larger studies, calculated using the between-group difference in asthma control on completion of the study 2. The estimated recruitment rate for future larger multisite studies, calculated using the recruitment rate of this study at the completion of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Between-group differences in: 1. Asthma control measured using: 1.1. The Asthma Control Questionnaire 6 (ACQ6) score 1.2. Asthma exacerbations requiring oral steroids (reported by the participant and confirmed by GP records) 1.3. Healthcare utilisation for asthma (reported by the participant and confirmed by GP records) 1.4. Reliever inhaler use (reported by participant and confirmed by GP records) Measured at baseline, 6 and 12 months 2. Adherence (Medicines Possession Ratio [MPR]) to preventer inhaler measured using prescription collection data from GP records at baseline, 6 and 12 months 3. Lung function measured using spirometry results (FEV1 and FVC) at baseline, 6 and 12 months 4. Airway inflammation measured using forces exhaled nitric oxide (FeNO) at baseline, 6 and 12 months 5. Health-related quality of life scores measured using mini asthma quality of life questionnaire (mAQLQ) and EQ-5D-5L questionnaire at baseline, 6 and 12 months 6. Behaviour change as measured by self-reported adherence using the test of adherence to inhalers (TAI) at baseline, 6 and 12 months 7. Healthcare resource use and cost measured through EQ-5D-5L, WPAI and study-specific health economic questionnaire and healthcare records at baseline, 6 and 12 months Digital inhaler group only: 8. The use, acceptability, and satisfaction of use of the FindAir system to patients and their families/carers, measured using the number of patients accepting the offer of digital inhaler continued use, feasibility questionnaire and interviews at baseline, 6 and 12 months 9. The feasibility for FindAir to be incorporated into routine standard care as part of the asthma clinical pathway, measured through the support needs of the patient and appointment times at 6 and 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactLynn Elsey
Outcome results
None listed