Study in COPD Patients Evaluating the Quality of Life (TRISNOOZE)

Chiesi SA/NV

Status: Terminated

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Combination Product: Trimbow

Study type: Observational

Funder types: Other

Identifiers

NCT04611633

CHIESI_NIS_004

Details and patient eligibility

About

This non-interventional study aims to collect information on the patient's quality of life, as well as the quality of sleep when stepping up to a fixed triple maintenance therapy (Trimbow®) as per physicians' decision, independent from study participation, and to assess its effectiveness in daily life, in general practitioner setting.

Full description

This non-interventional study assesses the real-life effectiveness, with focus on patient's quality of life, of the fixed triple therapy Trimbow® after stepping up from a dual therapy in clinical practice at first line centres in patients with confirmed chronic obstructive pulmonary disease (COPD). Data will be collected on availability as per usual care at baseline, 3 and 6 months after inclusion.

Enrollment: 14 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has provided written informed consent
• Patient is aged 40 years or older
• Current or ex-smokers with a smoking history ≥ 10 pack years
• Patient is diagnosed with COPD, confirmed by post-bronchodilator spirometry (Tiffeneau index <0.7; baseline or older spirometry)
• Patient is eligible for switch to triple therapy with at least 12 weeks of stable double inhalation therapy (ICS/LABA or LABA/LAMA) prior to enrolment to the study
• Patient is starting treatment with Trimbow® upon decision by their physician

Exclusion criteria

• Patients who are hypersensitive to one of the active substances or excipients
• Patients who are treated with triple therapy (via single or multiple inhalers) in the last 6 months prior to study enrolment
• Patients on ICS, LABA or LAMA monotherapy
• Patients with pneumonia and/or a moderate or severe COPD exacerbation not resolved ≥ 14 days prior to screening and ≥ 30 days following the last dose of oral/systemic corticosteroid (if applicable), or a respiratory tract infection not resolved ≥ 7 days prior to screening
• Patients participating simultaneously to other clinical trials or studies