Non-interventional Study Related to Fixed LAMA/LABA/ICS Triple Therapy

NCT04355546 | Completed

• 1 other identifier: NIS 004 Pn
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective non-interventional trial to measure the health related quality of life of patients with chronic obstructive pulmonary disease (COPD) on a fixed LAMA/LABA/ICS triple therapy (Trimbow®) and characterisation of determinants of treatment adherence.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Assess change in health related quality of life in COPD patients prescribed Trimbow

  Change in total CAT score between baseline and after 6 months of treatment.

  6 months

Secondary Outcomes (4)

• Assess adherence to COPD therapy

  6 months

• changes in relevant spirometry parameters

  6 months

• incidence of clinical events

  6 months

• Compare requirement of rescue medication and alteration of COPD therapy

  6 months

Study Arms (1)

COPD patients

Trimbow 87/5/9 pMDI for COPD prescribed according to licensed indication

Other: Non-interventional

Interventions

Non-interventional OTHER

As this is a Non-interventional trial, only data obtained within the current routine management of COPD at outpatient respiratory centres or GP centres will be documented.

COPD patients

Eligibility Criteria

• Age: 35 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will only be included in the Non-Interventional Trial if Trimbow® has been prescribed in line with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC). Physicians are urged to offer enrolment to all of their eligible patients consecutively as they present for their routine visit, and not select patients from their patient database. Eligible patients may only be included in the NIT after providing written (witnessed, where required by law or regulation), IEC-approved informed consent, or, if incapable of doing so, after such consent has been provided by a legally acceptable representative of the patient.

You may qualify if:

• Patients with moderate to severe COPD (with and without concomitant asthma)
• Physician decision to start therapy with Trimbow as per its current marketing authorisation; the treatment decision should be made independently from participation in this Non-Interventional Trial
• Patients with at least one COPD exacerbation within the previous 12 months
• Patients willing and able to sign informed consent for use of their pseudonymised clinical data within the present Non-Interventional Trial

You may not qualify if:

• Patients hospitalised due to an exacerbation of their COPD within the last 4 weeks prior to enrolment
• Participation within an interventional clinical trial within 30 days prior to enrolment into the present Non-Interventional Trial

Sponsors & Collaborators

• Chiesi UK: lead
• Liverpool Heart and Chest Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Liverpool Heart and Chest Foundation Trust

Liverpool, L14 3PE, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 21, 2020
• Study Start: July 15, 2020
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)