ASSIST Study: Investigation of a digital health solution providing real-time inhaler technique guidance

INTERVENTION: The main aim of the study is to establish whether the use of the Clip‐Tone System (CTS) improves and maintain inhaler technique in asthmatic patients over a 6‐month period compared with those receiving “usual care” alone. Other aims include: 1. To assess the use of the CTS in asthmatic patients (> 16 years) and its effects on asthma control and unscheduled clinical visits over a period of 6‐months 2. To develop an understanding of how patients use CTS in a real‐world setting 3. To develop an understanding of what frequency of use of CTS is desirable The Clip‐Tone System technology consists of two parts: 1. Clip‐Tone ‐ a small plastic retrofit device available in two variants (developed and manufactured by commercial partner Clement Clarke International; 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 manufactured inhalers (Fostair, Trimbow, Clenil brands) 2. Clip‐Tone Buddy app ‐ class I medical device accessory (CE marked), available on Apple and Google app stores. Both parts of the system are independently protected by patents (granted and pending) ‐ a collaboration agreement is in place clearly delineating background and foreground IP ownership. We will carry out a randomised controlled study comparing inhaler technique in those using Clip‐Tone System (CTS) with standard care (the “usual care” group) over a 6 month period. Potential recruits will attend a baseline visit where formal content to participate will be taken and elig CONDITION: Asthma ; Respiratory PRIMARY OUTCOME: Inhaler technique measured using an inhaler technique checklist (based on UK Inhaler Group standards) at baseline, 1 month, 3 months, and 6 months SECONDARY OUTCOME: ; 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.; 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 (