Clinical trial NCT05213611: REported Outcomes in COPD With Trixeo in Real worlD
Official title: A Non-interventional, Multi-centre Study to Investigate the Change in Clinical and Patient-reported Outcomes in Moderate to Severe COPD Patients Treated With TRIXEO (Budesonide / Glycopyrronium / Formoterol) Under Real-life Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-01-28
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The source population for this study is patients with moderate to severe COPD and who have been prescribed TRIXEO therapy in the primary care or hospital care setting may be enrolled in this study. Patients meeting all the inclusion criteria and none of the exclusion criteria may be enrolled by their physician.

The decision to start treatment with TRIXEO has to be made by the treating physician according to the subjects' medical need and a positive benefit/risk balance. The decision is not part of the study, lies with the treating physician and is taken according to the standard of current best medical practice and national guidelines.

Brief summary: Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms (including breathlessness, cough, and sputum production), which has a substantial impact on health-related quality of life (HRQoL). Medical treatment of COPD aims to reduce these symptoms, reduce exacerbations, and improve patients' ability to perform exercise and daily activities. TRIXEO is a triple therapy indicated as a maintenance treatment in adult patients with moderate-to-severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.

The RECORD study is a prospective, non-interventional study to be conducted in the United Kingdom (UK) and Germany. The study aims to generate data to describe the real world effectiveness of Trixeo for patients with COPD who receive Trixeo in routine clinical practice. It also aims describe patients HRQoL, physical activity and treatment satisfaction, and will explore patients' sleep quality and adherence to inhalers in the real-world. This data may provide important information for practicing physicians.

The study will include approximately 500 patients with moderate to severe COPD from approximately 50 sites (including hospitals and GP practices) in the UK. Patients eligible for TRIXEO therapy may be enrolled by their treating physicians. The decision to treat with TRIXEO must be independent of the study and made by the treating physician according to the patients' medical need and local routine clinical practice. Patients data will be collected for 12 months after starting therapy with Trixeo.

Demographic and clinical data will be extracted from patients' health care records. Patient reported outcomes will be collected remotely by asking patients to answer questionnaires on health status and HRQoL, treatment satisfaction, and inhaled medication adherence through electronic surveys. Consenting patients´ physical activity and sleep data will be collected via a Fitbit armband device.


Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed COPD
* Having been prescribed treatment with TRIXEO according to label and local market reimbursement criteria
* Patients must be able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol
* After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

* COPD due to α-1 antitrypsin deficiency
* Previous treatment with any other triple fixed-dose combination during screening
* Hospitalisation due to COPD exacerbation within the last 4 weeks prior to enrolment
* Pregnancy or lactation period
* Participation in an observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomised clinical trial in the last 30 days.
* Patient still recovering from Covid-19 infection

Primary outcomes:
measure: To describe the change in COPD health status after 3 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
timeFrame: 3 months
Secondary outcomes:
measure: Describe change in COPD health status after 1, 6 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
timeFrame: 12 months
measure: Describe change in health-related quality of life (HRQL) after 3 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment
timeFrame: 12 months
measure: Describe change in physical activity and activity limitations after 1, 3 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
timeFrame: 12 months
measure: Describe change in physical activity and activity limitations after 1, 3 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
timeFrame: 12 months
measure: Describe change in physical activity and activity limitations after 1, 3 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
timeFrame: 12 months
measure: Describe change in patient satisfaction with their inhalation device after 3 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment
timeFrame: 12 months
measure: Describe change in physician-reported exacerbation rate (moderate and severe exacerbations) after 6 and 12 months vs baseline
timeFrame: 12 months
Other outcomes:
Locations:
city: Ashton Under Lyne
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Birkenhead
country: United Kingdom
facility: Research Site
city: Bury St Edmunds
country: United Kingdom
facility: Research Site
city: Carmarthen
country: United Kingdom
facility: Research Site
city: Cippenham
country: United Kingdom
facility: Research Site
city: Dewsbury
country: United Kingdom
facility: Research Site
city: Gillingham
country: United Kingdom
facility: Research Site
city: Gloucestershire
country: United Kingdom
facility: Research Site
city: Greenisland
country: United Kingdom
facility: Research Site
city: Hampshire
country: United Kingdom
facility: Research Site
city: Harlow
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Louth
country: United Kingdom
facility: Research Site
city: Macclesfield
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Mundesley
country: United Kingdom
facility: Research Site
city: North Shields
country: United Kingdom
facility: Research Site
city: Nuneaton
country: United Kingdom
facility: Research Site
city: Prenton
country: United Kingdom
facility: Research Site
city: Preston
country: United Kingdom
facility: Research Site
city: Redruth
country: United Kingdom
facility: Research Site
city: Rhyl
country: United Kingdom
facility: Research Site
city: Stafford
country: United Kingdom
facility: Research Site
city: Taunton
country: United Kingdom
facility: Research Site
city: Waterlooville
country: United Kingdom
facility: Research Site
city: Watford
country: United Kingdom
facility: Research Site
city: Westcliff on Sea
country: United Kingdom
facility: Research Site
city: Wirral
country: United Kingdom
facility: Research Site
Study officials:
References: