Clinical trial NCT05311306: REported Outcomes in COPD With Trixeo in Real worlD in Germany
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
Keywords: Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-04-05
Enrollment: 475
Sex: ALL
Minimum age (years): 18
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 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.


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: Change from baseline in COPD Assessment Test (CAT) score after 3 months treatment
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline in CAT score after 1, 6 and 12 months treatment
timeFrame: 12 months
measure: Change from baseline in St George's Respiratory Questionnaire (SGRQ) score after 3 and 12 months treatment
timeFrame: 12 months
measure: Change from baseline in activity limitations, measured by CAT activity question/domain, after 1, 3 and 12 months of treatment
timeFrame: 12 months
measure: Change from baseline in activity limitations, measured by SGRQ activity question/domain, after 3 and 12 months of treatment
timeFrame: 12 months
measure: IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)© scores at baseline, 3 and 12 months
timeFrame: 12 months
measure: Change from baseline in exacerbation rate (moderate, severe) after 6 and 12 months of treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Auerbach
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bad Neustadt a.d. Saale
country: Germany
facility: Research Site
city: Bayreuth
country: Germany
facility: Research Site
city: Beelitz
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Biberach
country: Germany
facility: Research Site
city: Boeblingen
country: Germany
facility: Research Site
city: Bremen
country: Germany
facility: Research Site
city: Bremen
country: Germany
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
city: Darmstadt
country: Germany
facility: Research Site
city: Doerfles-Esbach
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Duesseldorf
country: Germany
facility: Research Site
city: Echterdingen
country: Germany
facility: Research Site
city: Ehringshausen
country: Germany
facility: Research Site
city: Filderstadt
country: Germany
facility: Research Site
city: Flensburg
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Fuerstenwalde
country: Germany
facility: Research Site
city: Fuerth
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hattingen
country: Germany
facility: Research Site
city: Ibbenbueren
country: Germany
facility: Research Site
city: Kronach
country: Germany
facility: Research Site
city: Laage
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Marburrg
country: Germany
facility: Research Site
city: Markkleeberg
country: Germany
facility: Research Site
city: Nuernberg
country: Germany
facility: Research Site
city: Nuernberg
country: Germany
facility: Research Site
city: Nuernberg
country: Germany
facility: Research Site
city: Peißenberg
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Rathenow
country: Germany
facility: Research Site
city: Rendsburg
country: Germany
facility: Research Site
city: Rosenheim
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Roth
country: Germany
facility: Research Site
city: Saalfeld
country: Germany
facility: Research Site
city: Saarlouis
country: Germany
facility: Research Site
city: Schleswig
country: Germany
facility: Research Site
city: Teuchern
country: Germany
facility: Research Site
city: Treuchtlingen
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Weißenburg
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Wilhelmshaven
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Wuerzburg
country: Germany
facility: Research Site
city: Zirndorf
country: Germany
facility: Research Site
Study officials:
References: