Asthma Respiratory
Conditions
Interventions
Current interventions as of 08/02/2023:
The main aim of the study is to establish whether the use of the Clip-Tone System (CTS) improves and maintains inhaler technique in asthmatic patients over a 6-
both CE marked, Class I medical devices available on prescription from May 2021)
1.1. Clip-Tone E fits GSK-manufactured Evohalers (Ventolin, Flixotide, Seretide brands)
1.2. Clip-Tone F fits Chiesi-ma
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated informed consent 2. Willingness to comply with the study procedures and confirmed availability for the study duration 3. Aged =16 years 4. Self-reported asthma diagnosis and currently receiving treatment 5. Regularly prescribed one of the following brands of inhaler and has been using it for at least 1-month prior to enrolment: 5.1. Fostair pMDI (100 mcg Beclometasone/ 6 mcg Formoterol per dose; 200 mcg Beclometasone/ 6mcg Formoterol per dose); Chiesi Ltd 5.2. Clenil Modulite pMDI (50 mcg, 100 mcg, 200 mcg or 250 mcg Beclometasone per dose); Chiesi Ltd 5.3. Trimbow pMDI (87 mcg Beclometasone, 5 mcg Formoterol, 9 mcg Glycopyrronium per dose); Chiesi Ltd 5.4. Seretide Evohaler pMDI (50 mcg Fluticasone/Salmeterol 25 mcg per dose; 125 mcg Fluticasone/Salmeterol 25 mcg per dose; 250 mcg Fluticasone/ Salmeterol 25 mcg per dose); GSK UK Ltd 5.5. Flixotide Evohaler pMDI (50 mcg Fluticasone per dose; 125 mcg Fluticasone per dose; 250 mcg Fluticasone per dose); GSK UK Ltd 6. Access to a smartphone or tablet device and willingness to use it to regularly assess inhaler technique for the study duration
Exclusion criteria
Exclusion criteria: 1. Using a spacer to assist with using their inhaler 2. Prescribed oral steroids for asthma in the preceding 1-month 3. Medication is not self-administered 4. Previous treatment for acute asthma in an ICU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 07/02/2024: Inhaler technique measured using inhalation time at baseline and 6 months and an inhaler technique checklist score (based on UK Inhaler Group standards) at baseline, 1 month, 3 months, and 6 months Previous primary outcome measure: Inhaler technique measured using an inhaler technique checklist (based on UK Inhaler Group standards) at baseline, 1 month, 3 months, and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Asthma control measured using the validated Asthma Control Questionnaire (ACQ) at baseline, 1 month, 3 months, and 6 months. 2. Frequency and pattern of use of the Clip-Tone System measured using usage data within the app at baseline, 1 month, 3 months, and 6 months. 3. Data on unscheduled healthcare visits measured through self-reported questionnaires at baseline, 1 month, 3 months, and 6 months. | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactNaomi Brooke
Outcome results
None listed