REported Outcomes in COPD With Trixeo in Real worlD

Chronic Obstructive Pulmonary Disease Clinical Trial

— RECORD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05213611
• Other study ID #: D5980R00051
• Status: Active, not recruiting
• Start date: August 11, 2022
• Est. completion date: June 29, 2024

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: June 29, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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 a-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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Research Site	Ashton-Under-Lyne
United Kingdom	Research Site	Bath
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Birkenhead
United Kingdom	Research Site	Bury St Edmunds
United Kingdom	Research Site	Carmarthen
United Kingdom	Research Site	Cippenham
United Kingdom	Research Site	Dewsbury
United Kingdom	Research Site	Gillingham
United Kingdom	Research Site	Gloucestershire
United Kingdom	Research Site	Greenisland
United Kingdom	Research Site	Hampshire
United Kingdom	Research Site	Harlow
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Louth
United Kingdom	Research Site	Macclesfield
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Mundesley
United Kingdom	Research Site	North Shields
United Kingdom	Research Site	Nuneaton
United Kingdom	Research Site	Prenton
United Kingdom	Research Site	Preston
United Kingdom	Research Site	Redruth
United Kingdom	Research Site	Rhyl
United Kingdom	Research Site	Stafford
United Kingdom	Research Site	Taunton
United Kingdom	Research Site	Waterlooville
United Kingdom	Research Site	Watford
United Kingdom	Research Site	Westcliff on Sea
United Kingdom	Research Site	Wirral

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the change in COPD health status after 3 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment	Change from baseline in COPD Assessment Test (CAT) score after 3 months treatment	3 months
Secondary	Describe change in COPD health status after 1, 6 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment	Change from baseline in CAT score after 1, 6 and 12 months treatment	12 months
Secondary	Describe change in health-related quality of life (HRQL) after 3 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment	Change from baseline in St George's Respiratory Questionnaire (SGRQ) score after 3 and 12 months treatment	12 months
Secondary	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	Change from baseline in device-measured steps per day after 3 and 12 months of treatment	12 months
Secondary	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	Change from baseline in activity limitations, measured by CAT activity question/domain, after 1, 3 and 12 months of treatment	12 months
Secondary	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	Change from baseline in activity limitations, measured by SGRQ activity question/domain, after 3 and 12 months of treatment	12 months
Secondary	Describe change in patient satisfaction with their inhalation device after 3 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment	IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)© scores at baseline, 3 and 12 months	12 months
Secondary	Describe change in physician-reported exacerbation rate (moderate and severe exacerbations) after 6 and 12 months vs baseline	Change from baseline in exacerbation rate (moderate, severe) after 6 and 12 months of treatment	12 months