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 (RECORD)

  • STATUS
    Recruiting
  • End date
    Mar 29, 2024
  • participants needed
    500
  • sponsor
    AstraZeneca
Updated on 12 October 2022

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.

Details
Condition Chronic Obstructive Pulmonary Disease
Clinical Study IdentifierNCT05213611
SponsorAstraZeneca
Last Modified on12 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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