TRIVOLVE: Fixed Dose Triple Therapy in Severe Chronic Obstructive Pulmonary Disease in a Real World Setting

Sponsor

Chiesi SA/NV (Other)

Overall Status

Completed

CT.gov ID

NCT03627858

Collaborator

(none)

149

Enrollment

Locations

24.1

Actual Duration (Months)

9.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The rationale for this non-interventional study in confirmed moderate to severe chronic obstructive pulmonary disease patients aged 40 years and above, is to assess real-life effectiveness and safety of Trimbow® in clinical practice, and to bridge the gap with the existing clinical data.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: beclomethasone / formoterol / glycopyrronium

Detailed Description

This non-interventional study assesses the real-life effectiveness and safety of the fixed triple therapy Trimbow® compared to free triple therapy, considering patient individual data, in clinical practice at second and thirdline centres in patients with confirmed moderate to severe chronic obstructive pulmonary disease.

This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.

Study Design

Study Type:

Observational

Actual Enrollment :

149 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective Non-interventional Study in Patients With Chronic Obstructive Pulmonary Disease That Evolve to Fixed Long-acting Muscarinic Antagonist/Long-acting beta2-agonist/Inhaled Corticosteroid Triple Therapy, Trimbow®

Actual Study Start Date :

Aug 1, 2018

Actual Primary Completion Date :

Aug 3, 2020

Actual Study Completion Date :

Aug 3, 2020

Outcome Measures

Primary Outcome Measures

Inhalation technique score [up to 6 months]
Change in Inhalation Technique Score, measured as percentage of correct steps on the Inhalation Checklist (itemized instructions of inhaler correct use per respective Summaries of Product Characteristics) at each routine follow-up visit up to 6 months versus baseline. This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.

Secondary Outcome Measures

Treatment adherence score [up to 6 months]
Degree of treatment adherence measured via the mean score on the Test of Adherence to Inhalers (TAI) questionnaire, including 5 questions completed by the patient (each item scored from 1 (worst) to 5 (best) with a range from 10 to 50) and 2 items completed by the physician (each item scored 1 (bad) or 2 (good) with a range from 2 to 4) at baseline and each routine follow-up visit up to 6 months versus baseline.
Number of inhaled doses recorded by dose counter since previous visit [up to 6 months]
Number of inhaled doses recorded by dose counter of the inhaler since previous visit, at the first and second routine follow-up visit.
Patient's treatment satisfaction score using visual analogue scale (0-10) [up to 6 months]
The patient's treatment satisfaction score measured on a visual analogue scale from 0 (worst) to 10 (best), at baseline and each routine follow-up visit.
Number of rescue medication used within 7 days prior to each visit [up to 6 months]
The number of rescue medication used within 7 days prior to each visit, recorded at baseline and each routine follow-up visit.
Patient's lung function as measured by spirometry [up to 6 months]
The pre and post bronchodilator forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) are measured at baseline and each routine follow-up visit.
Symptoms score by the Chronic obstructive pulmonary disease Assessment Test (CAT) questionnaire [up to 6 months]
Patients complete the 8-item CAT questionnaire at baseline and each follow-up visit. Total scores range from 0 to 40 and higher scores indicate a worse health status.

Other Outcome Measures

Number of moderate and severe exacerbations at baseline (12 months prior to start) and last follow-up visit [up to 6 months]
The number of moderate and severe exacerbations that occurred within the previous year is collected at the baseline visit and the number of moderate and severe exacerbations occurring during the study is collected at the final visit. Moderate exacerbations are defined as exacerbations that require oral corticosteroid and/or antibiotic treatment. Severe exacerbations are defined as exacerbations that require oral corticosteroid and/or antibiotic treatment plus hospital admission.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient has provided written informed consent
Patient is aged 40 years or older at time of initiation of Trimbow® treatment
Patient is diagnosed with moderate or severe chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) based on the Global Initiative for chronic obstructive lung disease (GOLD) 2018 classification
Patient treated with double inhalation or free triple therapy (using at least 2 devices) who are prescribed Trimbow®

Exclusion Criteria:

• Hypersensitivity to the active substances or to any of the excipients listed below:

Ethanol anhydrous
Hydrochloric acid
Norflurane (propellant)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	ZNA Middelheim	Antwerp	Belgium	2020
2	Universitair Ziekenhuis Antwerpen	Antwerp	Belgium	2650
3	GZA Campus Sint-Vincentius	Antwerp	Belgium
4	Hôpital Erasme	Brussels	Belgium
5	UZ Brussel	Brussel	Belgium
6	Grand Hôpital de Charleroi	Charleroi	Belgium	6000
7	Clinique Notre-Dame de Grâce ASBL Gosselies	Charleroi	Belgium
8	UZ Gent	Gent	Belgium
9	AZ Groeninge	Kortrijk	Belgium
10	CHR de la Citadelle	Liège	Belgium
11	AZ Sint-Maarten	Mechelen	Belgium
12	Hôpital André Vésale	Montigny-le-Tilleul	Belgium
13	Clinique Saint-Luc Bouge	Namur	Belgium
14	AZ Delta	Roeselare	Belgium
15	Hospital Center De Wallonie Picarde	Tournai	Belgium