Chronic Obstructive Pulmonary Disease MedDRA version: 18.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adults aged = 40 years with written informed consent obtained prior to any study-related procedure. 2. Patients with a diagnosis of severe or very severe COPD airflow obstruction (according to GOLD guidelines, updated 2014) at least 12 months before the screening visit. 3. Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years 4. A post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range 534
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use one or more methods of contraception as defined in the protocol 2. Patients with a current clinical diagnosis of asthma with a physician-judged need for inhaled or oral corticosteroid therapy 3. Patients requiring use systemic steroids, antibiotics, PDE4 inhibitors in the 4 weeks prior to screening 4. COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period. 5. Patients treated with non-cardioselective ß-blockers for at least 10 days before randomization. 6. Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study, or if taken as PRN. 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 drug according to the investigator’s judgment. 9. Patients who have clinically significant cardiovascular conditions 10. Patients with atrial fibrillation (AF) 11. An abnormal and clinically significant 12-lead ECG that results in active medical problem which may impact the safety of the patient according to investigator’s judgement. 12. Medical diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic agents. 13. History of hypersensitivity to M3 Antagonists, ß2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator’s judgement. 14. Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator’s judgement. 15. Patients with hypokalaemia or uncontrolled hyperkalaemia 16. Unstable concurrent disease which may impact the feasibility of the results of the study according to investigator’s judgment. 17. Patients with any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next six months (after V1) or with malignancy for which they are currently undergoing radiation therapy or chemotherapy. 18. History of alcohol abuse or substance/drug abuse within 12 months prior to screening visit. 19. Participation in another clinical trial where investigational drug was received less than 8 weeks prior to screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of CHF 5993 pMDI over Ultibro® in terms of moderate and severe COPD exacerbation rate over 52 weeks of treatment.;Secondary Objective: • To evaluate the effect of CHF 5993 pMDI on other lung function parameters, patient’s health status and clinical outcome measures. • To assess the safety and the tolerability of the study treatments. ;Primary end point(s): • Moderate and severe COPD exacerbation rate over 52 weeks of treatment. ;Timepoint(s) of evaluation of this end point: Study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time and rate of COPD exacerbation • Change from baseline pre-dose morning FEV1, FVC and FEV1 response • Change in SGRQ, CAT, EXACT-PRO score • Use of rescue medication and nocturnal symptoms;Timepoint(s) of evaluation of this end point: Study duration | — |
Countries
Argentina, Austria, Chile, Croatia, Czech Republic, Denmark, Germany, Hungary, Latvia, Mexico, Norway, Peru, Poland, Portugal
Contacts
Public ContactClinical Project Manager
Chiesi Farmaceutici S.p.A.
Outcome results
None listed