COPD MedDRA version: 19.0 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. Male and female aged = 40 years 2. A female is eligible to enter the study if she is of non-childbearing potential i.e. physiologically incapable of becoming pregnant 3. Subjects with an established diagnosis of COPD (according to GOLD guidelines, update 2015) at least 12 months prior to the screening visit 4. With a smoking history of at least 10 pack-years [pack-years=number of cigarettes per day x number of years/20]. Current and ex- smokers are eligible. (Smoking cessation must be at least 3 months prior to the screening. 5. With a BMI in the range of 18-35 Kg/m2 6. With a post- bronchodilator FEV1 = 30% and = 70% of the subject normal predicted value and a post-bronchodilator FEV1/FVC ratio =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female subject 2. Subjects with a current diagnosis of asthma 3. Subjects with a moderate or severe COPD exacerbation [i.e. resulting in the use of systemic (oral/IV/IM corticosteroids) and/or antibiotics or in hospitalisation] or a lower respiratory tract infection within 6 weeks prior to study entry or during the screening period 4. Subjects on maintenance bronchodilators therapy only (LABA alone, LAMA alone, dual LABA/LAMA alone) or maintenance dual therapy only (ICS/LABA or ICS plus LAMA) within 2 months prior to study entry 5. Subjects on PDE4 inhibitors (e.g. roflumilast) within 2 months prior to study entry 6. Subjects requiring long-term (at least 12 hours daily) oxygen therapy for chronic hypoxemia 7. Subjects participating to a pulmonary rehabilitation programme or completing such a programme within the last 6 weeks prior to study entry 8. Subjects with known respiratory disorders other than COPD that in investigator’s opinion would affect efficacy and safety evaluation or place the subject at risk. This can include but is not limited to known alpha-1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease 9. Subjects with active (lung) cancer or a history of lung cancer ;or a history of cancer other than lung cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized carcinoma (e.g. basal cell carcinoma (without metastases), in situ carcinoma of the cervix adequately treated,) is acceptable 10. Subjects with a known history of hypersensitivity to ß2-agonist, PDE4 inhibitors or any of the excipients contained in any of the formulations used in the trial 11. Subjects who have known history of clinically significant cardiovascular conditions such as, but not limited to, unstable or acute ischemic heart disease within one year prior to study entry, NYHA Class III/IV heart failure, known history of sustained and non-sustained cardiac arrhythmias or history of atrial fibrillation diagnosed in the last 6 months prior to study entry and not controlled with therapy rate control strategy as well as subjects with a history or symptoms of significant neurological disease including transient ischemic attack (TIA), stroke, seizure disorder or behavioural disturbances 12. Male subjects with a QTcF >450 ms and female subjects with a QTcF >470 ms at screening and/or at randomisation visits 13. Subjects who have unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment, significant renal impairment; history of cerebrovascular disease; uncontrolled gastrointestinal disease (e.g. active peptic ulcer, Crohn’s disease, ulcerative colitis, enteritis, unexplained diarrhea, bloody or loose stools); uncontrolled haematological disease; uncontrolled autoimmune disorders (e.g. rheumatoid arthritis, inflammatory bowel disease) or other disease or condition that might, in the judgement of the investigator , place the subject at undue risk or potentially compromise the results or interpretation of the study 14. Subjects with abnormal alanine aminotransferase (ALT) =2x upper limit of normal (ULN) and/ or aspartate aminotransferase (AST) =2x ULN and/or bilirubin =1.5x ULN. Isolated bilirubin =1.5x ULN is acceptable if fractionated and direct bilirubin is <35%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of CHF 6001 on biomarkers of inflammation in induced sputum and in blood;Secondary Objective: To evaluate the effect of CHF 6001 on biomarkers of inflammation on pulmonary function and on symptoms benefits in comparison with placebo To evaluate the safety and tolerability of CHF 6001 To assess the pharmacokinetics profile of CHF 6001 and its metabolites at steady state in subjects with moderate, severe COPD.;Primary end point(s): Pharmacokinetic: Plasma: AUC0-12h,ss, Cmin,ss, Cmax,ss, Cav,ss, tmax,ss, tmin,ss,CL/Fss (for CHF 6001 only), calculated from the individual 0-12h plasma concentration time profiles of CHF 6001 and its main metabolites CHF 5956 and CHF 6095 on Day 32 at steady state. sputum cell count and biomarkers ;Timepoint(s) of evaluation of this end point: on Day 32 at steady state | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ blood biomarkers 2/ lung function 3/ TDI, CAT scores 4/ PK parameters 5/ Safety (AEs, ADRs, vital signs) ;Timepoint(s) of evaluation of this end point: on day 32, except for AE ADR | — |
Countries
Germany, United Kingdom
Contacts
Public ContactClinical Project Manager
Chiesi Farmaceutici S.p.A.
Outcome results
None listed