RECORD: REported Outcomes in COPD With Trixeo in Real worlD in Germany

Sponsor

AstraZeneca (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05311306

Collaborator

(none)

500

Enrollment

Locations

18.5

Anticipated Duration (Months)

15.6

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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 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, treatment satisfaction, and inhaled medication adherence through electronic surveys. Consenting patients´ physical activity and sleep data will be collected via a Fitbit armband device.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Outcome Measures

Primary Outcome Measures

Change from baseline in COPD Assessment Test (CAT) score after 3 months treatment [3 months]
To describe the change in COPD health status after 3 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment

Secondary Outcome Measures

Change from baseline in CAT score after 1, 6 and 12 months treatment [12 months]
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 St George's Respiratory Questionnaire (SGRQ) score after 3 and 12 months treatment [12 months]
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 device-measured steps per day after 3 and 12 months of treatment [12 months]
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
Change from baseline in activity limitations, measured by CAT activity question/domain, after 1, 3 and 12 months of treatment [12 months]
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
Change from baseline in activity limitations, measured by SGRQ activity question/domain, after 3 and 12 months of treatment [12 months]
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
IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)© scores at baseline, 3 and 12 months [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
Change from baseline in exacerbation rate (moderate, severe) after 6 and 12 months of treatment [12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Research Site	Auerbach	Germany	08209
2	Research Site	Augsburg	Germany	86150
3	Research Site	Berlin	Germany	10178
4	Research Site	Berlin	Germany	10711
5	Research Site	Berlin	Germany	12099
6	Research Site	Berlin	Germany	12203
7	Research Site	Berlin	Germany	12627
8	Research Site	Berlin	Germany	13465
9	Research Site	Biberach	Germany	88400
10	Research Site	Bremen	Germany	28215
11	Research Site	Bremen	Germany	28259
12	Research Site	Cottbus	Germany	03050
13	Research Site	Darmstadt	Germany	64283
14	Research Site	Dresden	Germany	01324
15	Research Site	Duesseldorf	Germany	40489
16	Research Site	Ehringshausen	Germany	35630
17	Research Site	Flensburg	Germany	24937
18	Research Site	Hamburg	Germany	20354
19	Research Site	Hamburg	Germany	22041
20	Research Site	Ibbenbueren	Germany	49477
21	Research Site	Leipzig	Germany	04103
22	Research Site	Marburg	Germany	35037
23	Research Site	Markkleeberg	Germany	04416
24	Research Site	Potsdam	Germany	14478
25	Research Site	Rendsburg	Germany	24768
26	Research Site	Rosenheim	Germany	83022
27	Research Site	Rostock	Germany	18055
28	Research Site	Saalfeld	Germany	07318
29	Research Site	Saarlouis	Germany	66740
30	Research Site	Schleswig	Germany	24837
31	Research Site	Ulm	Germany	89073
32	Research Site	Wiesbaden	Germany	65183