Confirmatory Dose Finding Study of 2 Dosages of CHF 4226 pMDI (Carmoterol) in Patients With COPD
24 augustus 2010 bijgewerkt door: Chiesi Farmaceutici S.p.A.
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
The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be given once a day to patients with COPD in order for the effect to last for 24 hours.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
57
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arizona
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Gilbert, Arizona, Verenigde Staten, 85295
- Horizon Clinical Research Associates, PLLC
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Phoenix, Arizona, Verenigde Staten, 85006
- Pulmonary Associates, PA
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California
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Los Angeles, California, Verenigde Staten, 90095
- UCLA David Geffen School of Medicine
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Florida
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DeLand, Florida, Verenigde Staten, 32720
- University Clinical Research - Deland, LLC
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Georgia
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Austell, Georgia, Verenigde Staten, 30106
- Pulmonary Medicine and Critical Care
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Illinois
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Normal, Illinois, Verenigde Staten, 61761
- Sneeze, Wheeze & Itch Associates, LLC
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Kentucky
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Madisonville, Kentucky, Verenigde Staten, 42431
- Commonwealth BioMedical Research
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North Carolina
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Raleigh, North Carolina, Verenigde Staten, 27607
- North Carolina Clinical Research
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45242
- New Horizons Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73112
- Lynn Health Science Institute
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Oregon
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Medford, Oregon, Verenigde Staten, 97504
- Clinical Research Institute of Southern Oregon, PC
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Portland, Oregon, Verenigde Staten, 97213
- Asthma Allergy Associates
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South Carolina
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Spartanburg, South Carolina, Verenigde Staten, 29303
- Spartanburg Medical Research
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Texas
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Sugar Land, Texas, Verenigde Staten, 77074
- Reichman Associates
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84108
- University of Utah
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
40 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: A
CHF 4226 (carmoterol) 2 μg once a day, in the morning
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carmoterol (CHF 4226) 2 μg once a day, in the morning (1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)
Andere namen:
carmoterol (CHF 4226) 4 μg once a day, in the morning (1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)
Andere namen:
|
|
Experimenteel: B
CHF 4226 (carmoterol) 4 μg once a day, in the morning
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carmoterol (CHF 4226) 2 μg once a day, in the morning (1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)
Andere namen:
carmoterol (CHF 4226) 4 μg once a day, in the morning (1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)
Andere namen:
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Placebo-vergelijker: C
placebo once a day, in the morning
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placebo once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI) |
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Actieve vergelijker: D
salmeterol 50 μg twice daily, in the morning and in the evening
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Salmeterol 50 μg twice daily, in the morning and in the evening (1 blister of Serevent Diskus BID)
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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FEV1 AUC0-24 standardized by time
Tijdsspanne: on Day 15 (after 14 days of dosing)
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on Day 15 (after 14 days of dosing)
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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FEV1(L)
Tijdsspanne: 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
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blood pressure
Tijdsspanne: 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
Tijdsspanne: 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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FEV1 percent change
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Steven E. Linberg, PhD, Chiesi Farmaceutici S.p.A.
- Hoofdonderzoeker: Donald P. Tashkin, MD, University of California, Los Angeles
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2008
Primaire voltooiing (Werkelijk)
1 oktober 2008
Studie voltooiing (Werkelijk)
1 oktober 2008
Studieregistratiedata
Eerst ingediend
18 maart 2008
Eerst ingediend dat voldeed aan de QC-criteria
18 maart 2008
Eerst geplaatst (Schatting)
21 maart 2008
Updates van studierecords
Laatste update geplaatst (Schatting)
27 augustus 2010
Laatste update ingediend die voldeed aan QC-criteria
24 augustus 2010
Laatst geverifieerd
1 augustus 2010
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Longziekten
- Longziekten, obstructief
- Longziekte, chronisch obstructief
- Fysiologische effecten van medicijnen
- Adrenerge middelen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Adrenerge agonisten
- Bronchusverwijdende middelen
- Anti-astmatische middelen
- Agenten van het ademhalingssysteem
- Adrenerge bèta-2-receptoragonisten
- Adrenerge beta-agonisten
- Salmeterol Xinafoaat
Andere studie-ID-nummers
- CCD-0706-PR-0026
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .