The rationale for this non-interventional study in confirmed moderate to severe chronic obstructive pulmonary disease patients aged 40 years and above, is to assess real-life effectiveness and safety of Trimbow® in clinical practice, and to bridge the gap with the existing clinical data.
This non-interventional study assesses the real-life effectiveness and safety of the fixed triple therapy Trimbow® compared to free triple therapy, considering patient individual data, in clinical practice at second and thirdline centres in patients with confirmed moderate to severe chronic obstructive pulmonary disease. This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.
Study Type
OBSERVATIONAL
Enrollment
149
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.
ZNA Middelheim
Antwerp, Belgium
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
GZA Campus Sint-Vincentius
Antwerp, Belgium
Inhalation technique score
Change in Inhalation Technique Score, measured as percentage of correct steps on the Inhalation Checklist (itemized instructions of inhaler correct use per respective Summaries of Product Characteristics) at each routine follow-up visit up to 6 months versus baseline. This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.
Time frame: up to 6 months
Treatment adherence score
Degree of treatment adherence measured via the mean score on the Test of Adherence to Inhalers (TAI) questionnaire, including 5 questions completed by the patient (each item scored from 1 (worst) to 5 (best) with a range from 10 to 50) and 2 items completed by the physician (each item scored 1 (bad) or 2 (good) with a range from 2 to 4) at baseline and each routine follow-up visit up to 6 months versus baseline.
Time frame: up to 6 months
Number of inhaled doses recorded by dose counter since previous visit
Number of inhaled doses recorded by dose counter of the inhaler since previous visit, at the first and second routine follow-up visit.
Time frame: up to 6 months
Patient's treatment satisfaction score using visual analogue scale (0-10)
The patient's treatment satisfaction score measured on a visual analogue scale from 0 (worst) to 10 (best), at baseline and each routine follow-up visit.
Time frame: up to 6 months
Number of rescue medication used within 7 days prior to each visit
The number of rescue medication used within 7 days prior to each visit, recorded at baseline and each routine follow-up visit.
Time frame: up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hôpital Erasme
Brussels, Belgium
UZ Brussel
Brussels, Belgium
Grand Hôpital de Charleroi
Charleroi, Belgium
Clinique Notre-Dame de Grâce ASBL Gosselies
Charleroi, Belgium
UZ Gent
Ghent, Belgium
AZ Groeninge
Kortrijk, Belgium
CHR de la Citadelle
Liège, Belgium
...and 5 more locations
Patient's lung function as measured by spirometry
The pre and post bronchodilator forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) are measured at baseline and each routine follow-up visit.
Time frame: up to 6 months
Symptoms score by the Chronic obstructive pulmonary disease Assessment Test (CAT) questionnaire
Patients complete the 8-item CAT questionnaire at baseline and each follow-up visit. Total scores range from 0 to 40 and higher scores indicate a worse health status.
Time frame: up to 6 months