- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00640484
Confirmatory Dose Finding Study of 2 Dosages of CHF 4226 pMDI (Carmoterol) 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Arizona
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Gilbert, Arizona, Förenta staterna, 85295
- Horizon Clinical Research Associates, PLLC
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Phoenix, Arizona, Förenta staterna, 85006
- Pulmonary Associates, PA
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California
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Los Angeles, California, Förenta staterna, 90095
- UCLA David Geffen School of Medicine
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Florida
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DeLand, Florida, Förenta staterna, 32720
- University Clinical Research - Deland, LLC
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Georgia
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Austell, Georgia, Förenta staterna, 30106
- Pulmonary Medicine and Critical Care
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Illinois
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Normal, Illinois, Förenta staterna, 61761
- Sneeze, Wheeze & Itch Associates, LLC
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Kentucky
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Madisonville, Kentucky, Förenta staterna, 42431
- Commonwealth BioMedical Research
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North Carolina
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Raleigh, North Carolina, Förenta staterna, 27607
- North Carolina Clinical Research
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45242
- New Horizons Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73112
- Lynn Health Science Institute
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Oregon
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Medford, Oregon, Förenta staterna, 97504
- Clinical Research Institute of Southern Oregon, PC
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Portland, Oregon, Förenta staterna, 97213
- Asthma Allergy Associates
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South Carolina
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Spartanburg, South Carolina, Förenta staterna, 29303
- Spartanburg Medical Research
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Texas
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Sugar Land, Texas, Förenta staterna, 77074
- Reichman Associates
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Utah
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Salt Lake City, Utah, Förenta staterna, 84108
- University of Utah
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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):
- 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:
- 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 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: A
CHF 4226 (carmoterol) 2 μg once a day, in the morning
|
carmoterol (CHF 4226) 2 μg once a day, in the morning (1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)
Andra namn:
carmoterol (CHF 4226) 4 μg once a day, in the morning (1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)
Andra namn:
|
Experimentell: B
CHF 4226 (carmoterol) 4 μg once a day, in the morning
|
carmoterol (CHF 4226) 2 μg once a day, in the morning (1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)
Andra namn:
carmoterol (CHF 4226) 4 μg once a day, in the morning (1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)
Andra namn:
|
Placebo-jämförare: C
placebo once a day, in the morning
|
placebo once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI) |
Aktiv komparator: D
salmeterol 50 μg twice daily, in the morning and in the evening
|
Salmeterol 50 μg twice daily, in the morning and in the evening (1 blister of Serevent Diskus BID)
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
FEV1 AUC0-24 standardized by time
Tidsram: on Day 15 (after 14 days of dosing)
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on Day 15 (after 14 days of dosing)
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
FEV1(L)
Tidsram: 30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods
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30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods
|
blood pressure
Tidsram: at the beginning and end of each of the four 14-day treatment periods
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at the beginning and end of each of the four 14-day treatment periods
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heart rate
Tidsram: at the beginning and end of each of the four 14-day treatment periods
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at the beginning and end of each of the four 14-day treatment periods
|
FEV1 percent change
Tidsram: 30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods
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30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Steven E. Linberg, PhD, Chiesi Farmaceutici S.p.A.
- Huvudutredare: Donald P. Tashkin, MD, University of California, Los Angeles
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Lungsjukdomar
- Lungsjukdomar, obstruktiv
- Lungsjukdom, kronisk obstruktiv
- Läkemedels fysiologiska effekter
- Adrenerga medel
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Adrenerga agonister
- Bronkdilaterande medel
- Anti-astmatiska medel
- Andningsorgan
- Adrenerga beta-2-receptoragonister
- Adrenerga beta-agonister
- Salmeterol Xinafoate
Andra studie-ID-nummer
- CCD-0706-PR-0026
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