A clinical study to look at the safety, effectiveness and how COPD patients tolerate a new compound CHF6001 which will be inhaled daily for 28 days compared with existing treatment and placebo
- Conditions
- The participants of this study have chronic obstructive pulmonary disease (COPD).Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-001005-25-GB
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 65
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 <0.70.
9. A history of chronic bronchitis defined as chronic cough and sputum production for more than three months per year for two or more years and known as ‘spontaneous sputum producer’.
10. At screening, subjects must be able to produce an adequate induced sputum sample defined as a load of at least 75mg with a viability factor of not less than 40%, (with ideally less than 30 % epithelial cells). The subjects may be re-challenged by induction at least 48 hours later, if the first sputum sample did not meet these criteria. The re-challenge can be repeated until an adequate sputum sample is produced (at least 48 hours between attempts must be allowed). The subject will enter the Run-in Period only after an adequate sputum sample is produced.
11. At screening. subjects must be able to be trained to use the devices correctly and to generate sufficient PIF (at least 60 L/min) using the In-Check Dial® device.
12. Male subjects: they and/or their partner must be willing to use a reliable method of contraception from the time of dose administration and until 90 days after the last dose of study drug. Subjects must not donate sperm for 90 days after the last dose of study drug.
13. Female subjects: post-menopausal women having at least 12 months of natural (spontaneous) amenorrhea, or women of childbearing potential (defined as all women physiologically capable of becoming pregnant, using an acceptable method of contraception).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method