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OpenTrials
Completed

NCT Number: NCT05311306

REported Outcomes in COPD With Trixeo in Real worlD in Germany

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Böblingen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change from baseline in COPD Assessment Test (CAT) score after 3 months treatment

    Time frame: 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 outcomes

  1. Change from baseline in CAT score after 1, 6 and 12 months treatment

    Time frame: 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

  2. Change from baseline in St George's Respiratory Questionnaire (SGRQ) score after 3 and 12 months treatment

    Time frame: 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

  3. Change from baseline in activity limitations, measured by CAT activity question/domain, after 1, 3 and 12 months of treatment

    Time frame: 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

  4. Change from baseline in activity limitations, measured by SGRQ activity question/domain, after 3 and 12 months of treatment

    Time frame: 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

  5. IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)© scores at baseline, 3 and 12 months

    Time frame: 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

  6. Change from baseline in exacerbation rate (moderate, severe) after 6 and 12 months of treatment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: RECORD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2022
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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