Chronic obstructive pulmonary disease (COPD) MedDRA version: 21.0 Level: LLT Classification code 10070975 Term: Chronic obstructive bronchopneumopathy System Organ Class: 100000004855
Conditions
Interventions
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Product Name: Seretide diskus 50/500
Product Code: na
Pharmaceutical Form: Inhalation powder
Trade Name: SEREVENT - 50 MCG POL
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, >60 and =65 years) yes F.1.3.1 Number of subjects for this age range 118
Exclusion criteria
Exclusion criteria: 1. Inability to provide informed consent 2. Patient is hospitalized 3. Major surgical procedure in the previous four weeks 4. Participation in a clinical trial in the previous four weeks 5. Patient is current smoker 6. No COPD exacerbation in the previous year. 7. Patient has been hospitalized for COPD in the previous two months. 8. Other respiratory diseases in addition to COPD 9. Glaucoma 10. Any illness that could be immediately life threatening. 11. Upper respiratory infections or exacerbations in the previous 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Comparing the efficacy of ICS/LABA/LAMA vs LABA/LAMA in COPD patients with non-mixed phenotype (non-ACOS).;Secondary Objective: 1. Identifying molecular [gas chromatography/mass spectrometry (GC/MS), fraction of exhaled nitric oxide (FENO), electronic noses (e-noses), bacterial gene sequencing for airway microbiome identification], cellular (sputum analysis), imaging (chest multidetector row computed tomography, MDCT), biochemical [8-isoprostane and prostaglandin (PGE2) concentrations, both reported to be elevated in exhaled breath condensate (EBC) from COPD patients (17,18); PGE2 concentrations in sputum supernatants], and functional [including body plethysmography, forced oscillation technique (FOT), and single breath nitrogen washout] phenopypes, based on an innovative and validated platform, which is required for a better definition of non-mixed COPD phenotypes, for a more comprehensive consideration of the study covariates to be included in a pre-defined post-hoc analysis and, more importantly, for translating molecular phenotyping into a more personalized ;Primary end point(s): Occurrence of 1) one moderate or severe COPD exacerbation during the 52-week treatment phase (V3-V6), or 2) one episode of decrease in trough FEV1 = 15% on the volume scale or = 10% on the predicted scale or = 200 ml during the 52-week treatment phase (V3-V6) compared with pre-bronchodilator FEV1 at pre-treatment visit (V2) (8). The occurrence and severity of COPD exacerbations will be defined based on GOLD guidelines (6). ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Molecular: 1. E-Nose (Cyranose 320) sensor 1-32 resistance change 2. E-nose (Libranose) sensor 1-8 frequency change 3. Breath VOC concentrations identified and quantified by GC/MS 4. FENO Functional: 1. pre- and post-bronchodilator FEV1 2. pre- and post-bronchodilator forced vital capacity (FVC) 3. pre- and post-bronchodilator FEV1/FVC 4. pre- and post-bronchodilator peak expiratory flow (PEF) 5. pre- and post-bronchodilator forced expiratory flow at 25%-75% of the FVC (FEF25%-75%) 6. pre- and post-bronchodilator total lung capacity (TLC) 7. pre- and post-bronchodilator airway resistance (Raw) 8. pre- and post-bronchodilator specific airway conductance (sGaw) 9. nitrogen (N2) difference 0.75-1.25 (slope of phase III of single breath N2 washout) 10. closing volume (CV) (phase IV of single breath N2 washout) 11. pre- and post-bronchodilator FOT parameters Cellular 1. Neutrophil cell counts in sputum 2. Macrophage cell counts in sputum 3. Eosinophil cell counts in sputum 4. Lymphocyte cell counts in sputum 5.Total cell counts in sputum Biochemical: 1. 8-Isoprostane concentrations in EBC 2. PGE2 concentrations in EBC 3. PGE2 concentrations in sputum 4. Urinary 8-isoprostane Imaging 1. Airway lumen area (LA) 2. Percentage of airway wall area (WA%) 3. Airway wall thickness (WT) 4. Percentage of wall thickness (WT%) 5. Airway wall volume (WV) 6.10 mm lumenal perimeter (pi10) WA 7. percentage of volume index (VI%) < -950 HU for emphysema 8. VI% < -850 HU for air trapping 9. Mean lung density (MLD) expiration/inspiration (E/I) 10. VI -850 E-I (%) 11. Percentage of wall volume (WV%) Patient reported outcome: 1. St. George Respiratory Questionnaire (SGRT) ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Italy
Contacts
Public ContactUNITA' OPERATIVA COMPLESSA DI FARMA
POLICLINICO A. GEMELLI
Outcome results
None listed