Dose Finding Study of CHF 4226 for Treating Patients With COPD
NCT ID: NCT00605891
Last Updated: 2017-04-11
Study Results
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Basic Information
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COMPLETED
PHASE2
278 participants
INTERVENTIONAL
2006-10-31
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
carmoterol (CHF 4226) 1.0 μg once a day, in the morning
carmoterol (CHF 4226)
carmoterol pMDI 1.0 μg once a day, in the morning
(1 puff of carmoterol 1.0 mcg + 1 puff of placebo pMDI))
B
carmoterol (CHF 4226) 2.0 μg once a day, in the morning
carmoterol (CHF 4226)
carmoterol pMDI 2.0 μg once a day, in the morning
(1 puff of carmoterol 1.0 mcg + 1 puff of carmoterol 1.0 mcg)
C
carmoterol (CHF 4226) 4.0 μg once a day, in the morning
carmoterol (CHF 4226)
carmoterol pMDI 4.0 μg once a day, in the morning
(1 puff of carmoterol 2.0 mcg + 1 puff of carmoterol 2.0 mcg)
D
Placebo once a day, in the morning
placebo
Placebo pMDI once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)
E
Salmeterol 50 μg BID, in the morning and in the evening
salmeterol
Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID)
Interventions
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carmoterol (CHF 4226)
carmoterol pMDI 2.0 μg once a day, in the morning
(1 puff of carmoterol 1.0 mcg + 1 puff of carmoterol 1.0 mcg)
carmoterol (CHF 4226)
carmoterol pMDI 1.0 μg once a day, in the morning
(1 puff of carmoterol 1.0 mcg + 1 puff of placebo pMDI))
carmoterol (CHF 4226)
carmoterol pMDI 4.0 μg once a day, in the morning
(1 puff of carmoterol 2.0 mcg + 1 puff of carmoterol 2.0 mcg)
salmeterol
Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID)
placebo
Placebo pMDI once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
75 Years
ALL
No
Sponsors
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Chiesi USA, Inc.
INDUSTRY
Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Chiesi Pharmaceuticals Inc.
Principal Investigators
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Barry Make, MD
Role: PRINCIPAL_INVESTIGATOR
National Jewish Medical & Research Center
Steven E Linberg, Ph.D.
Role: STUDY_DIRECTOR
Chiesi Farmaceutici S.p.A.
Locations
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Clopton Clinic
Jonesboro, Arkansas, United States
ABM Research Center
Fresno, California, United States
UCSD - Clinical Trials Center
San Diego, California, United States
Institute of Healthcare Assessment Inc.
San Diego, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
Clinical Research of West Florida
Clearwater, Florida, United States
University Clinical Research - DeLand, LLC
DeLand, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Edward Hospital and Helath Services, Center for Clinical Trials
Naperville, Illinois, 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
Carolina Pharmaceutical Research
Statesville, North Carolina, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Toledo Center for Clinical Research
Sylvania, Ohio, United States
Clinical Research Institute of Southern Oregon PC
Medford, Oregon, United States
Pulmonary Consultants - Research Department
Medford, Oregon, United States
Lowcountry Lung and Critical Care, PA
North Charleston, South Carolina, United States
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, United States
Breath of Life Research Institute
Katy, Texas, United States
The University of Texas Health Center at Tyler
Tyler, Texas, United States
University of Wisconsin-Allergy/Asthma
Madison, Wisconsin, United States
Ordinace pro nemoci dychaciho ustroji
Beroun, , Czechia
OTRAN
Kutná Hora, , Czechia
Plicni a alergologicka ambulance
Kutná Hora, , Czechia
Pneumolog, internista
Lovosice, , Czechia
Nemocnice Na Homolce Plicni ambulance
Prague, , Czechia
Plicni ambulance
Praha 3 - Zizkov, , Czechia
Plicni ambulance Rokycany
Rokycany, , Czechia
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
Rüdersdorf, , Germany
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, , Poland
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, , Romania
Spitalul de Urgenta "Prof. Dr. Dimitrie Gerota"
Bucharest, , Romania
Spitalul Clinic de Urgenta Militar Central "Davila"
Bucharest, , Romania
Spitalul Clinic "Sf. Maria"
Bucharest, , Romania
Institutul National de Pneumoftisiologie "M. Nasta"
Bucharest, , Romania
Spitalul de Pneumoftiziologie Constanta
Constanța, , Romania
UCT Lung Institute
Mowbray, Cape Town, South Africa
Tiervlei Trial Center, Karl Bremer Hospital
Bellville, , South Africa
Countries
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References
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Matera MG, Cazzola M. ultra-long-acting beta2-adrenoceptor agonists: an emerging therapeutic option for asthma and COPD? Drugs. 2007;67(4):503-15. doi: 10.2165/00003495-200767040-00002.
Cazzola M, Matera MG, Lotvall 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. doi: 10.1517/13543784.14.7.775.
Matsukawa M, Takeda K, Shima H, Tagawa K, Banno K, Sato T. Enzyme-linked immunosorbent assay for TA-2005-glucuronide in human plasma. J Pharm Biomed Anal. 1998 Jun;17(2):245-54. doi: 10.1016/s0731-7085(97)00186-6.
Kikkawa H, Isogaya M, Nagao T, Kurose H. The role of the seventh transmembrane region in high affinity binding of a beta 2-selective agonist TA-2005. Mol Pharmacol. 1998 Jan;53(1):128-34. doi: 10.1124/mol.53.1.128.
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. doi: 10.1038/sj.bjp.0706096.
Rossoni G, Manfredi B, Razzetti R, Civelli M, Berti F. Positive interaction of the novel beta2-agonist carmoterol and tiotropium bromide in the control of airway changes induced by different challenges in guinea-pigs. Pulm Pharmacol Ther. 2007;20(3):250-7. doi: 10.1016/j.pupt.2006.01.004. Epub 2006 Mar 14.
Voss HP, Shukrula S, Wu TS, Donnell D, Bast A. A functional beta-2 adrenoceptor-mediated chronotropic response in isolated guinea pig heart tissue: selectivity of the potent beta-2 adrenoceptor agonist TA 2005. J Pharmacol Exp Ther. 1994 Oct;271(1):386-9.
Kikkawa H, Kanno K, Ikezawa K. TA-2005, a novel, long-acting, and selective beta 2-adrenoceptor agonist: characterization of its in vivo bronchodilating action in guinea pigs and cats in comparison with other beta 2-agonists. Biol Pharm Bull. 1994 Aug;17(8):1047-52. doi: 10.1248/bpb.17.1047.
Voss HP, Donnell D, Bast A. Atypical molecular pharmacology of a new long-acting beta 2-adrenoceptor agonist, TA 2005. Eur J Pharmacol. 1992 Dec 1;227(4):403-9. doi: 10.1016/0922-4106(92)90158-r.
Kikkawa H, Naito K, Ikezawa K. Tracheal relaxing effects and beta 2-selectivity of TA-2005, a newly developed bronchodilating agent, in isolated guinea pig tissues. Jpn J Pharmacol. 1991 Oct;57(2):175-85. doi: 10.1254/jjp.57.175.
Spadari-Bartfisch RC, Santos IN, Vanderlei LC, Marcondes FK. Pharmacological evidence for beta2-adrenoceptor in right atria from stressed female rats. Can J Physiol Pharmacol. 1999 Jun;77(6):432-40.
Related Links
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Study Record on EU Clinical Trials Register including results
Other Identifiers
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EudraCT Number: 2006-000531-10
Identifier Type: -
Identifier Source: secondary_id
US/PR/033009/001/05
Identifier Type: -
Identifier Source: org_study_id
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