Back to resultsTriple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease (TRICOLON)
Primary Purpose
Copd, Adherence, Medication
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
single-inhaler triple therapy (Trimbow)
E-health application: Curavista app & FindAir e-device
multi-inhaler triple therapy (Qvar + Bevespi)
Sponsored by
About this trial
This is an interventional other trial for Copd
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
Sites / Locations
- Franciscus Gasthuis & VlietlandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Control group
Intervention group 1
Intervention group 2
Arm Description
multi-inhaler triple therapy (Qvar and Bevespi)
single-inhaler triple therapy (Trimbow)
single-inhaler triple therapy (Trimbow) + e-health applications
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
TAI questionnaire score
questionnaire that identifies non-adherence and gives insight in the barriers related to the use of inhalers in asthma and COPD
CCQ questionnaire
measures health status and can be used to assess health-related quality of life
VAS score
a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied)
PIH-NL
12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD
WPAI
questionnaire to measure impairments in work and activities
EQ-5D-5L
questionnaire to assess the health-status
HLS-EU-Q16
assessment of patients' health literacy
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
SABA use
Use of espace medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05495698
Brief Title
Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
Acronym
TRICOLON
Official Title
Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Franciscus Gasthuis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd, Adherence, Medication
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
multi-inhaler triple therapy (Qvar and Bevespi)
Arm Title
Intervention group 1
Arm Type
Other
Arm Description
single-inhaler triple therapy (Trimbow)
Arm Title
Intervention group 2
Arm Type
Other
Arm Description
single-inhaler triple therapy (Trimbow) + e-health applications
Intervention Type
Drug
Intervention Name(s)
single-inhaler triple therapy (Trimbow)
Intervention Description
Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.
Intervention Type
Device
Intervention Name(s)
E-health application: Curavista app & FindAir e-device
Intervention Description
Patients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir
Intervention Type
Drug
Intervention Name(s)
multi-inhaler triple therapy (Qvar + Bevespi)
Intervention Description
Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.
Primary Outcome Measure Information:
Title
Adherence to ICS therapy
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
TAI questionnaire score
Description
questionnaire that identifies non-adherence and gives insight in the barriers related to the use of inhalers in asthma and COPD
Time Frame
12 months
Title
CCQ questionnaire
Description
measures health status and can be used to assess health-related quality of life
Time Frame
12 months
Title
VAS score
Description
a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied)
Time Frame
12 months
Title
PIH-NL
Description
12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD
Time Frame
12 months
Title
WPAI
Description
questionnaire to measure impairments in work and activities
Time Frame
12 months
Title
EQ-5D-5L
Description
questionnaire to assess the health-status
Time Frame
12 months
Title
HLS-EU-Q16
Description
assessment of patients' health literacy
Time Frame
12 months
Title
Number exacerbations
Description
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
Time Frame
12 months
Title
SABA use
Description
Use of espace medication
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Concentration of beclomethasone and formoterol in hair
Description
In a subgroup of patients, beclomethasone and formoterol concentration in their hair will be measured
Time Frame
2-3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liz Cuperus
Phone
+31108935567
Email
l.cuperus@franciscus.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Hans in 't Veen
Phone
+31104616800
Email
h.intveen@franciscus.nl
Facility Information:
Facility Name
Franciscus Gasthuis & Vlietland
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3045PM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liz Cuperus, Drs
Phone
+31108935567
Email
l.cuperus@franciscus.nl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
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