COPD MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000015472
Conditions
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject’s written informed consent obtained prior to any study-related procedure. 2. Male or Female COPD patients aged = 40 years. 3. Smoking history: of at least 10 pack-years 4. Smoking status: current or ex-smokers. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to screening visit. If the subjects undergo smoking cessation therapy, it must be completed 3 months prior to study entry. 5. Patients with documented COPD at least 12 months according to GOLD 2017. 6. Post-bronchodilator (BD) decreased Tiffeneau index: 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 women. 2. Patients with history or current diagnosis of asthma. 3. Medical history or current diagnosis of allergic rhinitis or atopy 4. Patients requiring use of the following medications: a. Systemic steroids for COPD exacerbation in the 4 weeks prior to screening; b. Patients with a moderate or severe COPD exacerbation [i.e. resulting in the use of systemic corticosteroids (oral/IV/IM) and or antibiotics or need for hospitalization within 6 weeks prior to screening] c. A course of antibiotics for COPD exacerbation longer than 7 days in the 4 weeks prior to screening; d. c-Phosphodiesterase-4 (PDE-4) inhibitors in the 4 weeks prior to screening; e. Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) in the 4 weeks prior to screening; 5. Patients treated with non-cardio-selective ß-blockers in the week prior screening. 6. Patients treated with long-acting anti-histamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study. 7. Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.7.Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia. 8.Known respiratory disorders other than COPD which may impact the efficacy of the study treatment according the Investigator’s judgment. 9.Lung cancer or history of lung cancer 10.Lung resection: subjects with a history of lung volume resection. 11.Subjects who have cardiovascular condition such as, but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, acute ischemic heart disease in the last year prior to study screening, which may impact the safety of the subject or the evaluation of the result of the study according to the Investigator’s judgment 12.ECG criteria: any clinically significant abnormal 12-lead ECG that in the investigator's opinion would affect efficacy or safety evaluation or place the patients at risk. 13.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. 14.History of hypersensitivity to M3 antagonists, ß2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the study which may raise contra-indications or impacted the efficacy of the study treatment according to the Investigator’s judgment. 15.Clinical Significant laboratory abnormalities indicating a significant or unstable concomitant disease which may have impacted the efficacy or the safety of the study treatment according to Investigator’s judgment. 16.Patients with serum potassium levels < 3.5 mEq/L (or 3.5 mmol/L). 17.Unstable concurrent disease which may impact the feasibility of the results of the study according to Investigator’s judgment. 18.History of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of inhaled extrafine CHF5993 pMDI on airway volumes, and resistance, by Functional Respiratory Imaging (FRI), in COPD patients treated with a non extrafine extemporary triple combination for three months, before entering the study. ;Secondary Objective: To evaluate the effect of inhaled extrafine CHF5993 pMDI on lung function parameters, on disease symptoms and Quality of Life, additional CFD based parameters, and aerosol deposition.; Primary end point(s): •Specific image-based airway volumes (siVaw): CT-based airway volumes normalized by the lung volume •Specific image-based airway resistance (siRaw): CFD-based airway resistance normalized by the lung volume ;Timepoint(s) of evaluation of this end point: during the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Internal Lobar Airflow Distribution • Air Trapping • Emphysema (Low Attenuation Score) • Airway Wall Volume • Blood Vessel Density • Ventilation/Perfusion Matching • Aerosol Deposition ;Timepoint(s) of evaluation of this end point: AEs, ADRs all across the study | — |
Countries
Belgium, Hungary
Contacts
Public ContactClinical Project Manager
Chiesi Farmaceutici S.p.A.
Outcome results
None listed