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

  • STATUS
    Recruiting
  • days left to enroll
    9
  • participants needed
    200
  • sponsor
    Chiesi UK
Updated on 15 February 2021
asthma
copd exacerbation

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.

Description

The primary goal of COPD therapy is the prevention of exacerbations and clinical deterioration. To achieve these goals, treatment adherence (i.e. taking medication as prescribed) is important. However, non-adherence (not taking medication as prescribed) is common in COPD and can be affected by lifestyle changes or use of multiple inhalers.

The effects of Trimbow on patients' health related quality of life, adherence and clinical outcomes have not been assessed in a UK real-world setting. This non-interventional trial aims to collect data from COPD patients under routine care over a 6 month period, for whom their doctors has decided to prescribe Trimbow as per the authorised indication. We plan to investigate any changes in quality of life, as well as changes in lung function and the need for any additional therapy over 6 months. We also plan to investigate the adherence or reasons for non-adherence to Trimbow as used in everyday routine.

Details
Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease), Reactive Airway Disease, chronic obstructive pulmonary disease, COPD, chronic obstructive pulmonary disease (copd)
Treatment Non-interventional
Clinical Study IdentifierNCT04355546
SponsorChiesi UK
Last Modified on15 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 35 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic Obstructive Lung Disease or COPD (Chronic Obstructive Pulmonary Disease)?
Do you have any of these conditions: Reactive Airway Disease or chronic obstructive pulmonary disease (copd) or chronic obstructive pulmonary disease or Chronic Obstructive Lung Disease o...?
Do you have any of these conditions: Reactive Airway Disease or chronic obstructive pulmonary disease (copd) or chronic obstructive pulmonary disease or COPD or Chronic Obstructive Lung D...?
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

Exclusion Criteria

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
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