Confirmatory Dose Finding Study of 2 Dosages of CHF 4226 pMDI (Carmoterol) in Patients With COPD
NCT ID: NCT00640484
Last Updated: 2010-08-27
Study Results
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Basic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2008-04-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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A
CHF 4226 (carmoterol) 2 μg once a day, in the morning
carmoterol (CHF 4226)
carmoterol (CHF 4226) 2 μg once a day, in the morning
(1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)
B
CHF 4226 (carmoterol) 4 μg once a day, in the morning
carmoterol (CHF 4226)
carmoterol (CHF 4226) 4 μg once a day, in the morning
(1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)
C
placebo once a day, in the morning
placebo
placebo once a day, in the morning
(1 puff of placebo pMDI + 1 puff of placebo pMDI)
D
salmeterol 50 μg twice daily, in the morning and in the evening
salmeterol
Salmeterol 50 μg twice daily, in the morning and in the evening
(1 blister of Serevent Diskus BID)
Interventions
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carmoterol (CHF 4226)
carmoterol (CHF 4226) 2 μg once a day, in the morning
(1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)
carmoterol (CHF 4226)
carmoterol (CHF 4226) 4 μg once a day, in the morning
(1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)
placebo
placebo once a day, in the morning
(1 puff of placebo pMDI + 1 puff of placebo pMDI)
salmeterol
Salmeterol 50 μg twice daily, in the morning and in the evening
(1 blister of Serevent Diskus BID)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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):
* FEV1/FVC \< 70%
* FEV1 is at least 0.9L
* FEV1 30% - 80%, inclusive, of patient's predicted normal value; ∆FEV1 \> 5% of pre-albuterol value
* If ∆FEV1 \< 5% of pre-albuterol value, requirement must be met after retesting during run-in period, at least 24 hours prior to Period 1/Visit 1.
Exclusion Criteria
* 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 anti-cholinergic agent (i.e., tiotropium): 7 days
* Short acting anti-cholinergics: 8 hours
* Fixed combinations of β2-agonists and inhaled corticosteroids: 48 hours
* Fixed combinations of an anti-cholinergic and short acting β2-agonist: 8 hours
* 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
40 Years
75 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Chiesi Pharmaceuticals Inc.
Principal Investigators
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Donald P. Tashkin, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Steven E. Linberg, PhD
Role: STUDY_DIRECTOR
Chiesi Farmaceutici S.p.A.
Locations
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Horizon Clinical Research Associates, PLLC
Gilbert, Arizona, United States
Pulmonary Associates, PA
Phoenix, Arizona, United States
UCLA David Geffen School of Medicine
Los Angeles, California, United States
University Clinical Research - DeLand, LLC
DeLand, Florida, United States
Pulmonary Medicine and Critical Care
Austell, Georgia, United States
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, United States
Commonwealth BioMedical Research
Madisonville, Kentucky, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Asthma Allergy Associates
Portland, Oregon, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Reichman Associates
Sugar Land, Texas, United States
University of Utah
Salt Lake City, Utah, United States
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.
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.
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.
Other Identifiers
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CCD-0706-PR-0026
Identifier Type: -
Identifier Source: org_study_id
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