REported Outcomes in COPD With Trixeo in Real worlD in Germany

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: NCT05311306
• Other study ID #: D5980R00037
• Status: Active, not recruiting
• Start date: March 15, 2022
• Est. completion date: October 12, 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 Germany. 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, physical activity, sleep quality, treatment satisfaction, and inhaled medication adherence through electronic surveys.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 475
• Est. completion date: October 12, 2024
• Est. primary completion date: October 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Germany	Research Site	Auerbach
Germany	Research Site	Augsburg
Germany	Research Site	Bad Neustadt a.d. Saale
Germany	Research Site	Bayreuth
Germany	Research Site	Beelitz
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Biberach
Germany	Research Site	Boeblingen
Germany	Research Site	Bremen
Germany	Research Site	Bremen
Germany	Research Site	Cottbus
Germany	Research Site	Darmstadt
Germany	Research Site	Doerfles-Esbach
Germany	Research Site	Dresden
Germany	Research Site	Duesseldorf
Germany	Research Site	Echterdingen
Germany	Research Site	Ehringshausen
Germany	Research Site	Filderstadt
Germany	Research Site	Flensburg
Germany	Research Site	Frankfurt
Germany	Research Site	Freiburg
Germany	Research Site	Fuerstenwalde
Germany	Research Site	Fuerth
Germany	Research Site	Halle
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Hattingen
Germany	Research Site	Ibbenbueren
Germany	Research Site	Kronach
Germany	Research Site	Laage
Germany	Research Site	Leipzig
Germany	Research Site	Marburg
Germany	Research Site	Marburrg
Germany	Research Site	Markkleeberg
Germany	Research Site	Nuernberg
Germany	Research Site	Nuernberg
Germany	Research Site	Nuernberg
Germany	Research Site	Peißenberg
Germany	Research Site	Potsdam
Germany	Research Site	Potsdam
Germany	Research Site	Rathenow
Germany	Research Site	Rendsburg
Germany	Research Site	Rosenheim
Germany	Research Site	Rostock
Germany	Research Site	Roth
Germany	Research Site	Saalfeld
Germany	Research Site	Saarlouis
Germany	Research Site	Schleswig
Germany	Research Site	Teuchern
Germany	Research Site	Treuchtlingen
Germany	Research Site	Ulm
Germany	Research Site	Weißenburg
Germany	Research Site	Wiesbaden
Germany	Research Site	Wilhelmshaven
Germany	Research Site	Witten
Germany	Research Site	Wuerzburg
Germany	Research Site	Zirndorf

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

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