Clinical trial NCT03627858: Fixed Dose Triple Therapy in Severe Chronic Obstructive Pulmonary Disease in a Real World Setting
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®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Chiesi SA/NV
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 149
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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®

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Inhalation technique score
timeFrame: up to 6 months
Secondary outcomes:
measure: Treatment adherence score
timeFrame: up to 6 months
measure: Number of inhaled doses recorded by dose counter since previous visit
timeFrame: up to 6 months
measure: Patient's treatment satisfaction score using visual analogue scale (0-10)
timeFrame: up to 6 months
measure: Number of rescue medication used within 7 days prior to each visit
timeFrame: up to 6 months
measure: Patient's lung function as measured by spirometry
timeFrame: up to 6 months
measure: Symptoms score by the Chronic obstructive pulmonary disease Assessment Test (CAT) questionnaire
timeFrame: up to 6 months
Other outcomes:
measure: Number of moderate and severe exacerbations at baseline (12 months prior to start) and last follow-up visit
timeFrame: up to 6 months
Locations:
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Antwerp
country: Belgium
facility: GZA Campus Sint-Vincentius
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Brussel
country: Belgium
facility: UZ Brussel
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
city: Charleroi
country: Belgium
facility: Clinique Notre-Dame de Grâce ASBL Gosselies
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Liège
country: Belgium
facility: CHR de la Citadelle
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Montigny-le-Tilleul
country: Belgium
facility: Hôpital André Vésale
city: Namur
country: Belgium
facility: Clinique Saint-Luc Bouge
city: Roeselare
country: Belgium
facility: AZ Delta
city: Tournai
country: Belgium
facility: Hospital Center De Wallonie Picarde
Study officials:
affiliation: University Ghent
name: Guy Brusselle, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: