Dose Finding Study of CHF 4226 for Treating Patients With COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT00605891
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
The purpose of this study is to identify the optimal once-daily dose of CHF 4226 to be further developed for the treatment of patients with COPD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
-
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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C carmoterol (CHF 4226) carmoterol (CHF 4226) 4.0 μg once a day, in the morning A carmoterol (CHF 4226) carmoterol (CHF 4226) 1.0 μg once a day, in the morning B carmoterol (CHF 4226) carmoterol (CHF 4226) 2.0 μg once a day, in the morning D placebo Placebo once a day, in the morning E salmeterol Salmeterol 50 μg BID, in the morning and in the evening
- Primary Outcome Measures
Name Time Method Change in FEV1 Day 1 to Day 14 (+3 days)
- Secondary Outcome Measures
Name Time Method FEV1 10 and 30 min, 1, 2, and 3 hrs post dose on Day 1, Day 2 and Day 14 (+3) ECG/QTc pre dose and post dose at 30' on Days 1, 2 and 14 (+3) Fasting serum potassium pre dose and post dose at 30' on Days 1, 2 and 14 (+3) Fasting glucose pre dose and post dose at 30' on Days 1, 2 and 14 (+3) Change in FEV1 10 and 30 min, 1, 2, and 3 hrs post dose on Day 1, Day 2 and Day 14 (+3)
Trial Locations
- Locations (50)
Ordinace pro nemoci dychaciho ustroji
🇨🇿Beroun, Czech Republic
University Clinical Research - DeLand, LLC
🇺🇸DeLand, Florida, United States
NZOZ Non-nocere
🇵🇱Gdansk, Poland
Klinika Pulmonologii i Alergologii
🇵🇱Lodz, Poland
Spitalul Clinic Judetean de Urgenta Brasov
🇷🇴Brasov, Romania
Spitalul Clinic "Sf. Maria"
🇷🇴Bucharest, Romania
Spitalul Clinic de Urgenta Militar Central "Davila"
🇷🇴Bucharest, Romania
UCSD - Clinical Trials Center
🇺🇸San Diego, California, United States
The University of Texas Health Center at Tyler
🇺🇸Tyler, Texas, United States
University of Wisconsin-Allergy/Asthma
🇺🇸Madison, Wisconsin, United States
Plicni ambulance Rokycany
🇨🇿Rokycany, Czech Republic
Plicni ambulance
🇨🇿Praha 3 - Zizkov, Czech Republic
Nemocnice Na Homolce Plicni ambulance
🇨🇿Praha 5, Czech Republic
Medars GmbH
🇩🇪Berlin, Germany
Clopton Clinic
🇺🇸Jonesboro, Arkansas, United States
ABM Research Center
🇺🇸Fresno, California, United States
Institute of Healthcare Assessment Inc.
🇺🇸San Diego, California, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Carolina Pharmaceutical Research
🇺🇸Statesville, North Carolina, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Clinical Research Institute of Southern Oregon PC
🇺🇸Medford, Oregon, United States
Lowcountry Lung and Critical Care, PA
🇺🇸North Charleston, South Carolina, United States
National Jewish Medical and Research Center
🇺🇸Denver, Colorado, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
OTRAN
🇨🇿Kutna Hora, Czech Republic
Plicni a alergologicka ambulance
🇨🇿Kutna Hora, Czech Republic
Pneumolog, internista
🇨🇿Lovosice, Czech Republic
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Delaware Valley Clinical Research
🇺🇸Cherry Hill, New Jersey, United States
Toledo Center for Clinical Research
🇺🇸Sylvania, Ohio, United States
Edward Hospital and Helath Services, Center for Clinical Trials
🇺🇸Naperville, Illinois, United States
Community Clinical Research Center
🇺🇸Anderson, Indiana, United States
ClinSite
🇺🇸Canton, Michigan, United States
Pulmonary Consultants - Research Department
🇺🇸Medford, Oregon, United States
Amarillo Center for Clinical Research, Ltd.
🇺🇸Amarillo, Texas, United States
Lungenzentrum Geesthacht
🇩🇪Geesthacht, Germany
Pneumologisches Forschungsinstitut GmbH
🇩🇪Grosshansdorf, Germany
Pneumologisches Forschungsinstitut Niederlassung Hamburg
🇩🇪Hamburg, Germany
Robert-Koch-Klinik
🇩🇪Leipzig, Germany
SMO, MD GmbH
🇩🇪Magdeburg, Germany
IFG GmbH
🇩🇪Ruedersdorf, Germany
Medcare Specjalistyczna Opieka Medyczna NZOZ
🇵🇱Gdansk, Poland
SPZOZ w Proszowicach Oddzial Chorob Pluc
🇵🇱Proszowice, Poland
Spitalul de Urgenta "Prof. Dr. Dimitrie Gerota"
🇷🇴Bucharest, Romania
Institutul National de Pneumoftisiologie "M. Nasta"
🇷🇴Bucharest, Romania
Spitalul de Pneumoftiziologie Constanta
🇷🇴Constanta, Romania
UCT Lung Institute
🇿🇦Mowbray, Cape Town, South Africa
Tiervlei Trial Center, Karl Bremer Hospital
🇿🇦Bellville, South Africa
ClinSite, LLC
🇺🇸Ann Arbor, Michigan, United States
Breath of Life Research Institute
🇺🇸Katy, Texas, United States