COPD (Chronic Obstructive Pulmonary Disease) MedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: CHF 5993 DPI 100/6/12,5
Product Code: CHF 5993 DPI
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Current Sponsor code: BDP
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject’s signed Informed Consent Form obtained prior to any study-related procedure; 2. Male or female = 40 years of age; 3. Current smokers and/or ex-smokers of at least 10 pack-years 4. Established diagnosis of COPD according to the 2020 GOLD Report, prior to the Screening visit (V1); 5. Post-BD FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating woman; 2. Exacerbations defined as a sustained and acute deterioration of subject’s symptoms and signs (dyspnoea, cough and/or sputum production/purulence) that are either moderate, i.e. require treatment with systemic (oral/IV/IM) corticosteroids and/or antibiotics, or severe, i.e. require hospitalization, if their associated treatment/hospitalization occurred within the 30 days before V1 (or 4 weeks in case the event was treated with just systemic corticosteroids) or if the event is recorded during the run-in period; 3. A current asthma diagnosis; 4. Respiratory disorders other than COPD 5. Cardiovascular diseases 6. Evidence or history of other concurrent disease 7. Medical history or current diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that in the opinion of the Investigator would have prevented use of anticholinergic agents; 8. History of lung transplant or lung reduction surgery; 9. ECG criteria: any clinically significant abnormal 12-lead ECG that in the investigator's opinion would affect efficacy or safety evaluation or place the subjects at risk. Male subjects with a QTcF >450msec and female subjects with a QTcF > 470msec at V1 are not eligible; 10. Laboratory abnormalities 11. Alcohol/drug abuse 12. Participation to investigational trial: subjects who have received any investigational drug within the 30 days or a more appropriate time as determined by the investigator (e.g. approximately 5 half-lives of the investigational drug, whatever is longer); 13. Contra-indications to IMPs, based on investigator judgement; 14. Hypersensitivity: history of hypersensitivity to any of the study medications components or a history of other allergy that in the opinion of the investigator contraindicates the subject's participation; 15. Subjects mentally or legally incapacitated or subjects accommodated in an establishment as a result of an official or judicial order; 16. Documented COVID-19 diagnosis or its complications which have not resolved within 14 days prior to screening; 17. Positive molecular COVID-19 test within the last 72 hours before the remaining of screening activities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of stepping-up from SERETIDE™ DISKUS™ (fluticasone propionate/salmeterol or FP/SLM 500/50 µg) DPI to extra fine CHF 5993 (BDP/FF/GB 100/6/12.5 µg) DPI on airway geometry and lung ventilation ;Secondary Objective: To assess therapeutic aerosol particles deposition, lung function following a switch from FP/SLM 500/50 µg DPI (SERETIDE™ DISKUS™) to extra fine BDP/FF/GB 100/6/12.5 µg DPI (CHF5993).;Primary end point(s): • Percentage change from baseline (pre-dose V2) to pre-dose in untrimmed specific airway volume (siVaw) upon inspiration (at Total Lung Capacity, TLC) at Visit 3 • Percentage change from baseline (pre-dose V2) to pre-dose in trimmed specific airway resistance (siRaw) upon inspiration (at TLC) at Visit 3 ;Timepoint(s) of evaluation of this end point: each period of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Values at pre-dose and post-dose for the following FRI parameters: •siVaw upon expiration (at Functional Residual Capacity, FRC) •siRaw upon expiration (at FRC) •ventilation mapping •perfusion mapping •airway wall thickness upon inspiration (at TLC) •imaged lobe and lung volumes at TLC and FRC •air trapping at FRC •low attenuation score at TLC •Percentile 15th at TLC •Regional lung deposition In addition, pre-dose spirometry, body plethysmography and CAT will be assessed at Visit 2 and Visit 3. safety variabels: •Adverse Events (AEs) and Adverse Drug Reactions (ADRs) •Vital signs (systolic and diastolic blood pressure) ;Timepoint(s) of evaluation of this end point: throughout the trial | — |
Countries
Hungary
Contacts
Public ContactClinical Project Manager
Chiesi Farmaceutici S.p.A.
Outcome results
None listed