chronic obstructive pulmonary disease (COPD) MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age & Informed consent: Male and female adults (40 = age = 85 years) with written informed consent obtained prior to any study-related procedure. 2.COPD Diagnosis: Established diagnosis of COPD (according to GOLD document updated 2017) at least 12 months prior to screening. 3.A Post-bronchodilator FEV1 =30% and =65 years) yes F.1.3.1 Number of subjects for this age range 253
Exclusion criteria
Exclusion criteria: 1.Pregnancy and lactation: Pregnant or lactating women and women of childbearing potential with fertile male partners UNLESS they and/or their partner are willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up contact. Being of non-childbearing potential is defined as meeting, at least, one of the following criteria: •at least 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile •previous surgical sterilization. 2.Diagnosis of asthma: Patients with a current clinical diagnosis of asthma. 3.Respiratory disorders other than COPD that would affect efficacy and safety evaluation or place the patient at risk. This can include but is not limited to known: alpha 1-antitrypsine deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease. 4.Lung cancer or history of lung cancer: Patients with a diagnosis of lung cancer or a history of lung cancer 5.Cancer or history of cancer (other than lung): Patients with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localised carcinoma (e.g. basal cell carcinoma, in situ carcinoma of the cervix adequately treated,..) is acceptable 6.Lung resection: Patients with a history of lung volume resection. 7.Lower tract respiratory infection that required use of antibiotics within 6 weeks prior to screening or during the run-in period. 8.History of exacerbations: Patients with a moderate or severe COPD exacerbation [i.e. resulting in the use of systemic corticosteroids (oral/IV/IM) and/or antibiotics and/or need for hospitalisation] within 6 weeks prior to screening or during the run-in period. 9.Oxygen therapy: Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia 10.Patients participating to a pulmonary rehabilitation programme or completing such a programme within 6 weeks prior to screening. 11.Cardiovascular diseases: Patients who have clinically significant cardiovascular condition 12.Atrial Fibrillation (AF) 13.ECG criteria: Any clinically significant abnormal 12-lead ECG that would affect efficacy or safety evaluation or place the patients at risk. 14.Concurrent diseases: Patients with medical history or current diagnosis of narrow-angle glaucoma, symptomatic prostatic hypertrophy, urinary retention or bladder neck obstruction that would prevent use of anticholinergic agents 15.Other concurrent diseases: Patients with historical or current evidence of uncontrolled concurrent disease such as but not limited to hyperthyroidism, diabetes mellitus or other endocrine disease; haematological disease; autoimmune disorders (e.g. rheumatoid arthritis); significant renal impairment or other diseases / conditions that might place the patient at undue risk or potentially compromise the results or interpretation of the study. 16.Laboratory abnormalities: Patients with clinically significant laboratory abnormalities indicating a significant unstable concomitant disease 17.Patients with hyp
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of FEV1 AUC0-12h normalized by time, in COPD patients. •To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of trough FEV1 at 24h on dosing Day 28 in COPD patients. ; Secondary Objective: •To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures. •To evaluate the safety and tolerability of the study treatments. ; Primary end point(s): 1) FEV1 AUC0-12h normalized by time 2) Trough FEV1 at 24h ; Timepoint(s) of evaluation of this end point: 1) On Day 1 and Day 28 of each treatment period 2) On Day 28 of each treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) other lung function parameters and clinical outcome measures. 2) safety and tolerability of the study treatments. ;Timepoint(s) of evaluation of this end point: across the trial | — |
Countries
Bulgaria, Czech Republic, Germany, Hungary, Poland
Contacts
Public ContactClinical Project Manager
Chiesi Farmaceutici S.p.A.
Outcome results
None listed