The participants of this study have chronic obstructive pulmonary disease (COPD).
Conditions
Interventions
Product Name: CHF 6001 DPI
Product Code: CHF 6001 DPI
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: NA
Current Sponsor code: CHF 6001
Concentration unit: µg microgram(s)
Co
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained prior to any study-related procedures. 2. Male or female aged between 40 and 70 years inclusive. 3. Current or past smoker of at least 10 pack/years. (If the subjects undergo smoking cessation therapy, it must be completed 3 months prior to the screening visit and smoking status should not change between the subjects screening visit and subjects last study visit). 4. BMI in the range of 18-35 Kg/m2. 5. A cooperative attitude and ability to be trained on the proper use of the Aerolizer inhaler, and to perform spirometry testing. 6. Subject must be able, in the Investigator’s opinion, to discontinue xanthines, antileukotrienes, cromoglycates, long acting (or nebulised) ß2-agonists, inhaled corticosteroids (ICS), oral and/or systemic corticosteroids and roflumilast, if already receiving these. They must remain stable, according to the Investigator’s judgement, on inhaled tiotropium 18µg daily with PRN salbutamol. • Xanthine derivatives, antileukotrienes, cromoglycates and roflumilast must be discontinued at least 4 weeks prior to Day 1 of the first study Period (i.e. 2 weeks prior to the screening visit). • ICS, LABA, oral and/or nebulised ß agonists must be discontinued at least 2 weeks prior to Day 1 of the first study Period (i.e. 12h prior to the screening visit). • Oral and/or systemic corticosteroids must not be taken within 6 weeks prior to the screening visit 7. In the Investigator’s opinion subjects should be able to withhold tiotropium 24h prior to the screening visit. 8. GOLD Stage 2 and 3 COPD subjects as defined by the GOLD guidelines with a post- bronchodilator FEV1 between 40-80% of the predicted value and a ratio FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, 2. Past or current history of asthma. 3. History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness. 4. History or symptoms of significant cardiovascular disease, particularly coronary artery disease, arrhythmias, or congestive heart failure. 5. History or symptoms of significant neurological disease including transient ischemic attack (TIA), stroke, seizure disorder or behavioural disturbances. 6. Unstable concurrent disease which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would in the opinion of the Investigator pose an unacceptable risk to the subject in this study. 7. An abnormal and clinically significant 12-lead ECG that results in an active medical problem, as defined by the Investigator, or an electrocardiogram (12-lead ECG) with QTcF > 450 ms for males or QTcF > 470 ms for females. 8. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation. 9. A worsening of COPD or a lower respiratory tract infection requiring use of oral or systemic corticosteroids, oral and/or nebulised ß2 agonists and/or antibiotics within 6 weeks preceding the screening visit. 10. The need for chronic use of any other medication for treatment of lung disease like xanthines, antileukotrienes, systemic and inhaled corticosteroids, long acting ß2-agonists, roflumilast (other than the study drug) and cromoglycates during the study Period. 11. Current participation in a pulmonary rehabilitation programme or completion of such a programme within the last 6 weeks. 12. Subjects requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxaemia. 13. Subjects having received any other investigational drug within the preceding 30 days, or a longer and more appropriate time as determined by the Investigator (e.g., approximately five half-lives of the previous investigational drug). 14. Blood draws of 250 mL or more within 45 days prior to enrolment into the study. 15. Known respiratory disorders other than COPD including but not limited to asthma, a-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease. 16. Recent (less than 1 year) history of alcohol dependency, or substance abuse that in the opinion of the Investigator may be of clinical significance. 17. Unwillingness or inability to comply with the study Protocol for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are: - to evaluate the effect of CHF 6001 DPI on biological markers of inflammation in induced sputum and in the blood, and on pulmonary function. - to evaluate the safety and tolerability of CHF 6001 DPI after 28 days of inhaled dosing - to assess the blood PK profile of CHF6001 and its metabolite at steady-state in GOLD stage 2-3 COPD patients ;Secondary Objective: This is an exploratory study therefore the objectives have not been identified as either primary or secondary;Primary end point(s): This is an exploratory study therefore the objectives and the endpoints have not been identified as either primary or secondary The primary objectives of the study are: - to evaluate the effect of CHF 6001 DPI on biological markers of inflammation in induced sputum and in the blood, and on pulmonary function. - to evaluate the safety and tolerability of CHF 6001 DPI after 28 days of inhaled dosing - to assess the blood PK profile of CHF6001 and its metabolite at steady-state in GOLD stage 2-3 COPD patients ;Timepoint(s) of evaluation of this end point: Biomarkers - Sputum Days 21, 24, 28 Blood day 28 Pulmonary Function days 9, 21, 24, 28 PK Paramaters -Day 28 Safety & Tolerability - Day 28 PK profile - Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There is no secondary endpoint;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United Kingdom
Contacts
Public ContactOriana Esposito
Chiesi Farmaceutici S.p.A.
Outcome results
None listed