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OpenTrials
Completed

NCT Number: NCT03627858

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GZA Campus Sint-Vincentius, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

beclomethasone / formoterol / glycopyrronium

Drug

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.

Other names: Trimbow®

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. Number of moderate and severe exacerbations at baseline (12 months prior to start) and last follow-up visit

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chiesi SA/NV

Other

Registry information

Official study 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®

Acronym: TRIVOLVE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2018
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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