Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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.
Detailed 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.
Interventions
COMBINATION_PRODUCTTrimbow
As this is a non-interventional study, all treatment decisions will be made at the discretion of the treating physician prior to enrolment in the study and during the entire period of the study. Treatment will be prescribed according to the product label in the summary of product characteristics.
Sponsors
Chiesi SA/NV
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COPD symptoms | 6 months | The patient's COPD symptoms at month 6 (visit 3), compared to baseline. This is measured by the COPD Assessment Test (CAT) questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COPD symptoms | 3 months | The patient's COPD symptoms at month 3 (visit 2) |
| Quality of sleep | 6 months | The quality of sleep of the patients using the CASIS questionnaire at baseline, month 3 and 6 (visit 2 and 3) |
| Rescue medication | 6 months | Use of rescue medication at baseline and each follow-up visit (question on the past 7 days) |
| Lung function parameters | 6 months | Lung function parameters (FEV1, FVC) (if available) at baseline and each follow-up visit |
| Treatment satisfaction | 6 months | The patient's treatment satisfaction score using PGI-C at month 3 and 6 (visit 2 and 3) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Moderate/severe exacerbations | 6 months | Number of moderate/severe exacerbations at baseline and at month 6 |
Countries
Belgium
Outcome results
None listed