Fixed Dose Triple Therapy in Severe Chronic Obstructive Pulmonary Disease in a Real World Setting
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT03627858
- Lead Sponsor
- Chiesi SA/NV
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- Patient has provided written informed consent
- Patient is aged 40 years or older at time of initiation of Trimbow® treatment
- Patient is diagnosed with moderate or severe chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) based on the Global Initiative for chronic obstructive lung disease (GOLD) 2018 classification
- Patient treated with double inhalation or free triple therapy (using at least 2 devices) who are prescribed Trimbow®
• Hypersensitivity to the active substances or to any of the excipients listed below:
- Ethanol anhydrous
- Hydrochloric acid
- Norflurane (propellant)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Inhalation technique score up to 6 months 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.
- Secondary Outcome Measures
Name Time Method Treatment adherence score up to 6 months 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.
Number of inhaled doses recorded by dose counter since previous visit up to 6 months Number of inhaled doses recorded by dose counter of the inhaler since previous visit, at the first and second routine follow-up visit.
Patient's treatment satisfaction score using visual analogue scale (0-10) up to 6 months 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.
Patient's lung function as measured by spirometry up to 6 months 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.
Symptoms score by the Chronic obstructive pulmonary disease Assessment Test (CAT) questionnaire up to 6 months 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.
Number of rescue medication used within 7 days prior to each visit up to 6 months The number of rescue medication used within 7 days prior to each visit, recorded at baseline and each routine follow-up visit.
Trial Locations
- Locations (15)
Clinique Notre-Dame de Grâce ASBL Gosselies
🇧🇪Charleroi, Belgium
UZ Gent
🇧🇪Gent, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
CHR de la Citadelle
🇧🇪Liège, Belgium
AZ Sint-Maarten
🇧🇪Mechelen, Belgium
Hôpital André Vésale
🇧🇪Montigny-le-Tilleul, Belgium
ZNA Middelheim
🇧🇪Antwerp, Belgium
GZA Campus Sint-Vincentius
🇧🇪Antwerp, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Antwerp, Belgium
Grand Hôpital de Charleroi
🇧🇪Charleroi, Belgium
UZ Brussel
🇧🇪Brussel, Belgium
AZ Groeninge
🇧🇪Kortrijk, Belgium
Clinique Saint-Luc Bouge
🇧🇪Namur, Belgium
Hospital Center De Wallonie Picarde
🇧🇪Tournai, Belgium
Hôpital Erasme
🇧🇪Brussels, Belgium