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

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®

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Antwerp, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Antwerp, Belgium
    • GZA Campus Sint-Vincentius
  • Brussel, Belgium
    • UZ Brussel
  • Brussels, Belgium
    • Hopital Erasme
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi
  • Charleroi, Belgium
    • Clinique Notre-Dame de Grâce ASBL Gosselies
  • Gent, Belgium
    • UZ Gent
  • Kortrijk, Belgium
    • AZ Groeninge
  • Liège, Belgium
    • CHR de la Citadelle
  • Mechelen, Belgium
    • AZ Sint-Maarten
  • Montigny-le-Tilleul, Belgium
    • Hôpital André Vésale
  • Namur, Belgium
    • Clinique Saint-Luc Bouge
  • Roeselare, Belgium
    • AZ Delta
  • Tournai, Belgium
    • Hospital Center De Wallonie Picarde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 40 years or above diagnosed with chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) who were prescribed Trimbow®

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chiesi SA/NV
• Investigators: Principal Investigator: Guy Brusselle, MD-PhD, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): August 3, 2020
• Study Completion (Actual): August 3, 2020

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Beclomethasone; Glycopyrrolate; Formoterol Fumarate
• Other Study ID Numbers: CHIESI_NIS_0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No