Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease

• single-inhaler triple therapy (Trimbow) (Drug): Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.
• E-health application: Curavista app & FindAir e-device (Device): Patients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir
• multi-inhaler triple therapy (Qvar + Bevespi) (Drug): Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.

Primary outcomes

• Adherence to ICS therapy [12 months]: average adherence to ICS therapy (expressed as a percentage, measured as the number of actuations registered by the e-device divided by the total number of prescribed doses) over 12 months of treatment

Secondary outcomes

• TAI questionnaire score [12 months]: questionnaire that identifies non-adherence and gives insight in the barriers related to the use of inhalers in asthma and COPD
• CCQ questionnaire [12 months]: measures health status and can be used to assess health-related quality of life
• VAS score [12 months]: a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied)
• PIH-NL [12 months]: 12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD
• WPAI [12 months]: questionnaire to measure impairments in work and activities
• EQ-5D-5L [12 months]: questionnaire to assess the health-status
• HLS-EU-Q16 [12 months]: assessment of patients' health literacy
• Number exacerbations [12 months]: A moderate exacerbation is defined as sustained worsening of the patient's condition, from a stable state and beyond day-to-day variation, that is acute in onset and warrants additional treatment (systemic corticosteroids and/or antibiotics). An exacerbation is defined as severe if hospitalization or emergency department visit is necessary
• SABA use [12 months]: Use of espace medication

Other outcomes

• Concentration of beclomethasone and formoterol in hair [2-3 months]: In a subgroup of patients, beclomethasone and formoterol concentration in their hair will be measured

Sex: All, ages: 40 Years to any

Inclusion Criteria:

* Clinical diagnosis of COPD for at least 1 year before the screening visit
* Aged 40 years and older
* An indication for triple therapy according to the treating physician (following the GOLD guideline 2021(2)). Could be step-up from dual therapy or currently receiving triple therapy (both MITT and SITT).
* Owner of mobile device compatible with e-device app with access to internet (Android or iOS)
* Willing to provide written informed consent
* Current or ex-smoker

Exclusion Criteria:

* Inability to comply with study procedures or with study treatment
* Insufficiently skilled in the Dutch language to be able to read and understand the app. Help by third party (family members) is allowed
* Asthma as the predominant disease according to the investigator's opinion, a past history of asthma is allowed
* Use of e-health application for COPD in the past six months
* Patients with any other therapy that could interfere with the study drugs (according to the investigator's opinion)
* Use of nebulized bronchodilators, for example via pari boy
* Pregnant or lactating women and all women physiologically capable of becoming pregnant unless they have highly effective contraceptive
* Patients mentally or legally incapacitated, or patients accommodated in an establishment as a result of an official or judicial order
* Patients without the capability to complete the questionnaires

• Results publication: Cuperus LJA, van der Palen J, Aldenkamp A, van Huisstede A, Bischoff EWMA, van Boven JFM, Brijker F, Dik S, van Excel JAJM, Goosens M, van Hal PTW, Kuijvenhoven JC, Kunz LIZ, Vasbinder EC, Kerstjens HAM, In 't Veen JCCM; TRICOLON study group. Adherence to single inhaler triple therapy and digital inhalers in Chronic Obstructive Pulmonary Disease: a literature review and protocol for a randomized controlled trial (TRICOLON study). BMC Pulm Med. 2024 Jul 4;24(1):317. doi: 10.1186/s12890-024-03044-3. PMID 38965541