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

NCT03627858 | Completed

• 1 other identifier: CHIESI_NIS_0001
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 15

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Treatment adherence score

  up to 6 months

• Number of inhaled doses recorded by dose counter since previous visit

  up to 6 months

• Patient's treatment satisfaction score using visual analogue scale (0-10)

  up to 6 months

• Number of rescue medication used within 7 days prior to each visit

  up to 6 months

• Patient's lung function as measured by spirometry

  up to 6 months

Other Outcomes (1)

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

  up to 6 months

Interventions

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.

Also known as: Trimbow®

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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®

You may qualify if:

• 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®

You may not qualify if:

• Hypersensitivity to the active substances or to any of the excipients listed below:
• Ethanol anhydrous
• Hydrochloric acid
• Norflurane (propellant)

Sponsors & Collaborators

• Chiesi SA/NV: lead

Study Sites (15)

ZNA Middelheim

Antwerp, 2020, Belgium

Location

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

Location

GZA Campus Sint-Vincentius

Antwerp, Belgium

Location

Hôpital Erasme

Brussels, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

Grand Hôpital de Charleroi

Charleroi, 6000, Belgium

Location

Clinique Notre-Dame de Grâce ASBL Gosselies

Charleroi, Belgium

Location

UZ Gent

Ghent, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

CHR de la Citadelle

Liège, Belgium

Location

AZ Sint-Maarten

Mechelen, Belgium

Location

Hôpital André Vésale

Montigny-le-Tilleul, Belgium

Location

Clinique Saint-Luc Bouge

Namur, Belgium

Location

AZ Delta

Roeselare, Belgium

Location

Hospital Center De Wallonie Picarde

Tournai, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Beclomethasone; Formoterol Fumarate; Glycopyrrolate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Guy Brusselle, MD-PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: August 14, 2018
• Study Start: August 1, 2018
• Primary Completion: August 3, 2020
• Study Completion: August 3, 2020
• Last Updated: November 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (15)