Evaluation of the Effect of 2 Weeks Treatment With CHF 4226 pMDI 2µg and 4µg, Given Once Daily in the Morning, on 24-Hour FEV1 in Patients With COPD
Evaluation of the Effect of 2 Weeks Treatment With CHF 4226 pMDI 2µg and 4µg, Given Once Daily in the Morning, on 24-Hour FEV1 in Patients With COPD
The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be given once a day to patients with COPD in order for the effect to last for 24 hours.
Inclusion Criteria:
Signed IRB approved Informed Consent form
Male or non-pregnant female, 40 -75 years old, inclusive
Current or past cigarette smoking history of at least 15 pack-years
Clinical diagnosis of COPD in accordance with recommendations of the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Patient meets following requirements after FEV1 albuterol reversibility test (i.e., 30 minutes after 200μg (metered dose) albuterol MDI):
Exclusion Criteria:
History of asthma
Blood eosinophil count > 500/microliters
History of allergic rhinitis or atopy
COPD exacerbation or lower respiratory tract infection within 8 weeks prior to screening, or during run-in period, that resulted in use of an antibiotic, or oral or parenteral corticosteroids
Inhaled corticosteroid that has been initiated, or effective dose has been changed, within 4 weeks prior to screening or during run-in period
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 Investigator's judgment, place patient at undue risk or potentially compromise study results or interpretation
History of coronary artery disease, cerebrovascular disease, cardiac arrhythmias
Lung cancer or history of lung cancer
Active cancer or history of cancer with < 5 years disease free survival time (with or without evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of skin is acceptable.
Serum potassium value ≤ 3.5 mEq/L or > 5.5mEq/L and/or fasting serum glucose value ≥ 140 mg/dL
Abnormal QTcF interval value in Screening visit ECG test (i.e., > 450 msec in males or > 470 msec in females)
Cor Pulmonale
Long term oxygen therapy, i.e., > 16 hours/24-hour period, every day, unless patient resides at elevation > 4000ft
Use of any of the following medications prior to Screening, without meeting specified minimum washout period:
Long-acting β2-agonists: 48 hours
Short acting β2-agonists (other than those prescribed in the study): 6 hours
Theophylline and other xanthines: 1 week
Parenteral or oral corticosteroids: 1 month
Patient has taken any non-permitted medication
Patient has received live-attenuated virus vaccination within two weeks prior to screening or during run-in (inactivated Influenza vaccination is acceptable if given > 48 hours prior to Screening)
Known intolerance/hypersensitivity to β2-adrenergic agonists, propellant gases/excipients
Patient is pregnant or lactating female, or female at risk of pregnancy (i.e., not using adequate contraceptive method: surgical sterilization [e.g., bilateral tubal ligation], hormonal contraception [implantable, patch, oral], IUD, and double-barrier methods [any double combination of: male or female condom with spermicidal gel, diaphragm, sponge, cervical cap]).
Patient is mentally or legally incapacitated
Patient has participated in another investigational study within 30 days prior to screening
Abuse of alcohol or other substances
Patient does not maintain regular day/night, waking/sleeping cycles (e.g., night shift worker)
Patient is potentially non-compliant or unable to perform required protocol outcome measurements