Liverpool Heart and Chest Foundation Trust
Liverpool, L14 3PE, United Kingdom
NCT Number: NCT04355546
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.
Looking for future studies?
Notify Me35 year–100 year
All sexes
Observational
Liverpool, L14 3PE, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
Change in total CAT score between baseline and after 6 months of treatment.
Time frame: 6 months
changes in adherence scores (assessed by means of TAI questionnaire),
Time frame: 6 months
between baseline, e.g. FEV1, FVC
Time frame: 6 months
e.g. exacerbations
Time frame: 6 months
incidence of COPD medication changes and rescue medication use medication changes and rescue medication use
Chiesi UK
Industry
A Prospective Non-interventional Trial on COPD Patients' Health Related Quality of Life Under a Fixed LAMA/LABA/ICS Triple Therapy and Characterization of Determinants of Treatment Adherence
Acronym: TriOptimize
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03927820
Asthma, Bronchial Diseases
Nashville, Tennessee, United States
View Trial DetailsNCT06614959
Bronchial Diseases, Bronchitis
Montreal, Quebec, Canada
View Trial DetailsNCT04754490
COPD, Chronic Disease
Abercynon, Wales, United Kingdom
View Trial DetailsNCT06336252
Arthritis, Basal Ganglia Diseases
Copenhagen, Denmark
View Trial Details