Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomized, Controlled,14-Treatment Day, Multicenter Study to Determine the Optimal Efficacious and Safe Dose of CHF 4226 in a Metered Dose Inhaler in Treating Patients With Chronic Obstructive Pulmonary Disease
Verified date | April 2017 |
Source | Chiesi Farmaceutici S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 278 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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% Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Czech Republic | Ordinace pro nemoci dychaciho ustroji | Beroun | |
Czech Republic | OTRAN | Kutna Hora | |
Czech Republic | Plicni a alergologicka ambulance | Kutna Hora | |
Czech Republic | Pneumolog, internista | Lovosice | |
Czech Republic | Plicni ambulance | Praha 3 - Zizkov | |
Czech Republic | Nemocnice Na Homolce Plicni ambulance | Praha 5 | |
Czech Republic | Plicni ambulance Rokycany | Rokycany | |
Germany | Medars GmbH | Berlin | |
Germany | 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 | |
Poland | Medcare Specjalistyczna Opieka Medyczna NZOZ | Gdansk | |
Poland | NZOZ Non-nocere | Gdansk | |
Poland | Klinika Pulmonologii i Alergologii | Lodz | |
Poland | SPZOZ w Proszowicach Oddzial Chorob Pluc | Proszowice | |
Romania | Spitalul Clinic Judetean de Urgenta Brasov | Brasov | |
Romania | Institutul National de Pneumoftisiologie "M. Nasta" | Bucharest | |
Romania | Spitalul Clinic "Sf. Maria" | Bucharest | |
Romania | Spitalul Clinic de Urgenta Militar Central "Davila" | Bucharest | |
Romania | Spitalul de Urgenta "Prof. Dr. Dimitrie Gerota" | Bucharest | |
Romania | Spitalul de Pneumoftiziologie Constanta | Constanta | |
South Africa | Tiervlei Trial Center, Karl Bremer Hospital | Bellville | |
South Africa | UCT Lung Institute | Mowbray | Cape Town |
United States | Amarillo Center for Clinical Research, Ltd. | Amarillo | Texas |
United States | Community Clinical Research Center | Anderson | Indiana |
United States | ClinSite, LLC | Ann Arbor | Michigan |
United States | ClinSite | Canton | Michigan |
United States | Delaware Valley Clinical Research | Cherry Hill | New Jersey |
United States | New Horizons Clinical Research | Cincinnati | Ohio |
United States | Clinical Research of West Florida | Clearwater | Florida |
United States | University Clinical Research - DeLand, LLC | DeLand | Florida |
United States | National Jewish Medical and Research Center | Denver | Colorado |
United States | ABM Research Center | Fresno | California |
United States | Clopton Clinic | Jonesboro | Arkansas |
United States | Breath of Life Research Institute | Katy | Texas |
United States | University of Wisconsin-Allergy/Asthma | Madison | Wisconsin |
United States | Clinical Research Institute of Southern Oregon PC | Medford | Oregon |
United States | Pulmonary Consultants - Research Department | Medford | Oregon |
United States | Edward Hospital and Helath Services, Center for Clinical Trials | Naperville | Illinois |
United States | Lowcountry Lung and Critical Care, PA | North Charleston | South Carolina |
United States | Institute of Healthcare Assessment Inc. | San Diego | California |
United States | UCSD - Clinical Trials Center | San Diego | California |
United States | Carolina Pharmaceutical Research | Statesville | North Carolina |
United States | Toledo Center for Clinical Research | Sylvania | Ohio |
United States | Clinical Research of West Florida, Inc. | Tampa | Florida |
United States | The University of Texas Health Center at Tyler | Tyler | Texas |
United States | Palm Beach Research Center | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Chiesi Farmaceutici S.p.A. | Chiesi USA |
United States, Czech Republic, Germany, Poland, Romania, South Africa,
Cazzola M, Matera MG, Lötvall J. Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease. Expert Opin Investig Drugs. 2005 Jul;14(7):775-83. Review. — View Citation
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Rossoni G, Manfredi B, Razzetti R, Civelli M, Bongrani S, Berti F. Positive interaction of the beta2-agonist CHF 4226.01 with budesonide in the control of bronchoconstriction induced by acetaldehyde in the guinea-pigs. Br J Pharmacol. 2005 Feb;144(3):422-9. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in FEV1 | Day 1 to Day 14 (+3 days) | ||
Secondary | FEV1 | 10 and 30 min, 1, 2, and 3 hrs post dose on Day 1, Day 2 and Day 14 (+3) | ||
Secondary | ECG/QTc | pre dose and post dose at 30' on Days 1, 2 and 14 (+3) | ||
Secondary | Fasting serum potassium | pre dose and post dose at 30' on Days 1, 2 and 14 (+3) | ||
Secondary | Fasting glucose | pre dose and post dose at 30' on Days 1, 2 and 14 (+3) | ||
Secondary | Change in FEV1 | 10 and 30 min, 1, 2, and 3 hrs post dose on Day 1, Day 2 and Day 14 (+3) |
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