Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
The first group will receive multi-inhaler triple therapy (control group), the
second group single-inhaler triple therapy (intervention group 1) and the third
group single-inhaler triple therapy wit
Sponsors
Franciscus
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 investigator*s judgement (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
Exclusion criteria: • Inability to comply with study procedures or with study treatment • Inability to speak and/or read Dutch • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average adherence to inhalation therapy (expressed in a percentage, measured as the number of actuations registered by the e-device divided by the total dose) over 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in TAI questionnaire score, beclomethasone and/or formoterol accumulation profile in hair analysis and differences in clinical outcomes and Patient Reported Outcome Measures (PROM*s), such as the Clinical COPD Questionnaire (CCQ), number of exacerbations and Salbutamol use | — |
Countries
Netherlands
Contacts
Public ContactL.J.A. Cuperus
Franciscus
Outcome results
None listed