Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
With
Chiesi USA, Inc.
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient has signed an IRB-/Ethics Committee-approved Informed Consent form
Patient is a male or non-pregnant female between the ages of 40 - 75 years, inclusive
Patient has a current or past smoking history of at least 15 pack-years
Patient has a clinical diagnosis of COPD in accordance with the recommendations of the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Patient meets the following requirements after an FEV1 albuterol reversibility test (i.e., 30 minutes following 200 mcg (metered dose) albuterol/salbutamol pMDI):
FEV1 is at least 0.9L
FEV1 of 40% - 70%, inclusive, of patient's predicted normal value
Change in FEV1 \> 4% of patient's predicted normal value
* If change in FEV1 \< 4% of patient's predicted normal value, then this requirement must be met after retesting during the run-in period, at least 24 hours prior to Day -1
FEV1/FVC \< 70%
You may not be if
Patient has a history of asthma, allergic rhinitis, or atopy
Patient has a blood eosinophil count \> 500/microliter
Patient had a COPD exacerbation or a lower respiratory tract infection within 8 weeks prior to screening, or during the run-in period, that resulted in the use of an antibiotic, or oral or parenteral corticosteroids
Patient is on an inhaled corticosteroid that has been initiated, or the effective dose has been changed, within 4 weeks prior to screening or during the run-in period
Patient has an uncontrolled cardiovascular (e.g., uncontrolled hypertension), respiratory, hematologic, immunologic, renal, neurologic, hepatic, endocrine (e.g., uncontrolled diabetes mellitus) or other disease, or any condition that might, in the judgment of the Investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
Patient has a history of coronary artery disease, cerebrovascular disease, cardiac arrhythmias
Patient has a concomitant disease of poor prognosis (e.g., cancer)
Patient has a serum potassium value ≤ 3.5 mEq/L or \>5.5mEq/L and/or a fasting serum glucose value ≥ 140 mg/dL
Patient has an abnormal QTc Fridericia interval value in the Screening visit ECG test (i.e., \> 450 msec in males or \> 470 msec in females)
Patient has developed Cor Pulmonale
Patient is receiving long term oxygen therapy, i.e., ≥ 16 hours/24-hour period, every day
Patient has a known intolerance/hypersensitivity to Beta2-adrenergic agonists, propellant gases/excipients
Patient is receiving treatment with a tricyclic antidepressant or a monoamine oxidase inhibitor (MAOI)
Patient has received a live-attenuated virus vaccination within two weeks prior to screening or during the run-in
Patient is pregnant or lactating female, or female at risk of pregnancy (i.e., not using an adequate contraceptive method)
Patient is mentally or legally incapacitated
Patient has participated in another investigational study within 30 days prior to screening
Patient abuses alcohol or other substances
Patient is potentially non-compliant or unable to perform required outcome measurements of the protocol
Clareo Health | Dose Finding Study of CHF 4226 for Treating Patients With COPD
