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

Chronic Obstructive Pulmonary Disease Clinical Trial

— TRIVOLVE  

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627858
• Other study ID #: CHIESI_NIS_0001
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: August 3, 2020

Study information

• Verified date: November 2021
• Source: Chiesi SA/NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: August 3, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• beclomethasone / formoterol / glycopyrronium
As this is a non-interventional study, all treatment decisions will be made at the discretion of the treating physician prior to enrolment in the study and during the entire period of the study. Treatment will be prescribed according to the product label in the summary of product characteristics.

Locations

Country	Name	City	State
Belgium	GZA Campus Sint-Vincentius	Antwerp
Belgium	Universitair Ziekenhuis Antwerpen	Antwerp
Belgium	ZNA Middelheim	Antwerp
Belgium	UZ Brussel	Brussel
Belgium	Hôpital Erasme	Brussels
Belgium	Clinique Notre-Dame de Grâce ASBL Gosselies	Charleroi
Belgium	Grand Hôpital de Charleroi	Charleroi
Belgium	UZ Gent	Gent
Belgium	AZ Groeninge	Kortrijk
Belgium	CHR de la Citadelle	Liège
Belgium	AZ Sint-Maarten	Mechelen
Belgium	Hôpital André Vésale	Montigny-le-Tilleul
Belgium	Clinique Saint-Luc Bouge	Namur
Belgium	AZ Delta	Roeselare
Belgium	Hospital Center De Wallonie Picarde	Tournai

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi SA/NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of moderate and severe exacerbations at baseline (12 months prior to start) and last follow-up visit	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.	up to 6 months
Primary	Inhalation technique score	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.	up to 6 months
Secondary	Treatment adherence score	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.	up to 6 months
Secondary	Number of inhaled doses recorded by dose counter since previous visit	Number of inhaled doses recorded by dose counter of the inhaler since previous visit, at the first and second routine follow-up visit.	up to 6 months
Secondary	Patient's treatment satisfaction score using visual analogue scale (0-10)	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.	up to 6 months
Secondary	Number of rescue medication used within 7 days prior to each visit	The number of rescue medication used within 7 days prior to each visit, recorded at baseline and each routine follow-up visit.	up to 6 months
Secondary	Patient's lung function as measured by spirometry	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.	up to 6 months
Secondary	Symptoms score by the Chronic obstructive pulmonary disease Assessment Test (CAT) questionnaire	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.	up to 6 months