Clinical trial NCT05495698: Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
Official title: Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Copd
Adherence, Medication
Lead sponsor: Franciscus Gasthuis
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 with extra digital support to increase therapy adherence (intervention group 2).
Primary purpose: OTHER

Brief summary: TRICOLON is an investigator initiated, prospective, interventional, open-label, randomized, real-world, multi-centre, 3-arms study in the Netherlands. The primary objective is to investigate in COPD patients if single-inhaler triple therapy (SITT) is superior to multi-inhaler triple therapy (MITT) in terms of adherence to inhaled corticosteroids (ICS) therapy and to investigate if SITT with e-health support is superior to MITT and SITT without e-health support.


Eligibility 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 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

Primary outcomes:
measure: Adherence to ICS therapy
timeFrame: 12 months
Secondary outcomes:
measure: TAI questionnaire score
timeFrame: 12 months
measure: CCQ questionnaire
timeFrame: 12 months
measure: VAS score
timeFrame: 12 months
measure: PIH-NL
timeFrame: 12 months
measure: WPAI
timeFrame: 12 months
measure: EQ-5D-5L
timeFrame: 12 months
measure: HLS-EU-Q16
timeFrame: 12 months
measure: Number exacerbations
timeFrame: 12 months
measure: SABA use
timeFrame: 12 months
Other outcomes:
measure: Concentration of beclomethasone and formoterol in hair
timeFrame: 2-3 months
Locations:
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
state: Zuid-Holland
Study officials:
References: