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

Copd Clinical Trial

— TRICOLON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495698
• Other study ID #: FranciscusGasthuis
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Franciscus Gasthuis
• Contact: Liz Cuperus
• Phone: +31108935567
• Email: l.cuperus[@]franciscus.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• Copd
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• single-inhaler triple therapy (Trimbow)
Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.

Device:
• E-health application: Curavista app & FindAir e-device
Patients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir

Drug:
• multi-inhaler triple therapy (Qvar + Bevespi)
Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.

Locations

Country	Name	City	State
Netherlands	Franciscus Gasthuis & Vlietland	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Franciscus Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concentration of beclomethasone and formoterol in hair	In a subgroup of patients, beclomethasone and formoterol concentration in their hair will be measured	2-3 months
Primary	Adherence to ICS therapy	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	12 months
Secondary	TAI questionnaire score	questionnaire that identifies non-adherence and gives insight in the barriers related to the use of inhalers in asthma and COPD	12 months
Secondary	CCQ questionnaire	measures health status and can be used to assess health-related quality of life	12 months
Secondary	VAS score	a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied)	12 months
Secondary	PIH-NL	12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD	12 months
Secondary	WPAI	questionnaire to measure impairments in work and activities	12 months
Secondary	EQ-5D-5L	questionnaire to assess the health-status	12 months
Secondary	HLS-EU-Q16	assessment of patients' health literacy	12 months
Secondary	Number exacerbations	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	12 months
Secondary	SABA use	Use of espace medication	12 months