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

Chiesi SA/NV

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: beclomethasone / formoterol / glycopyrronium

Study type: Observational

Funder types: Other

Identifiers

NCT03627858

CHIESI_NIS_0001

Details and patient eligibility

About

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 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.

Enrollment: 149 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)