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

Overview

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.

Full Title of Study: “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®”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2020

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Inhalation technique score
    • Time Frame: 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 Measures

  • Treatment adherence score
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chiesi SA/NV
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Guy Brusselle, MD-PhD, Principal Investigator, University Ghent
  • Overall Contact(s)
    • Sofie Geelissen, PhD, +3227884222, s.geelissen@chiesi.com

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