Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo (LAC-MD-27)
16. januar 2017 oppdatert av: AstraZeneca
Efficacy and Safety Study of Two Fixed-Dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate, and Placebo All Administered Twice Daily (BID) to Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
128
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Glendale, Arizona, Forente stater, 85306
- Forest Investigative Site 0909
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Pheonix, Arizona, Forente stater, 85006
- Forest Investigative Site 2050
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California
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Rancho Mirage, California, Forente stater, 92270
- Forest Investigative Site 2029
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Stockton, California, Forente stater, 95207
- Forest Investigative Site 1084
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Colorado
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Wheat Ridge, Colorado, Forente stater, 80033
- Forest Investigative Site 2045
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Florida
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Clearwater, Florida, Forente stater, 33765
- Forest Investigative Site 1152
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Tampa, Florida, Forente stater, 33603
- Forest Investigative Site 2053
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Tampa, Florida, Forente stater, 33613
- Forest Investigative Site 2047
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Massachusetts
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N. Dartmouth, Massachusetts, Forente stater, 02747
- Forest Investigative Site 1431
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New Jersey
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Summit, New Jersey, Forente stater, 07901
- Forest Investigative Site 2084
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New York
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Elmira, New York, Forente stater, 14901
- Forest Investigative Site 1119
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North Carolina
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Elizabeth city, North Carolina, Forente stater, 27909
- Forest Investigative Site 2035
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Raleigh, North Carolina, Forente stater, 27607
- Forest Investigative Site 1153
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Ohio
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Cincinnati, Ohio, Forente stater, 45242
- Forest Investigative Site 2028
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Oregon
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Medford, Oregon, Forente stater, 97504
- Forest Investigative Site 2043
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Portland, Oregon, Forente stater, 97213
- Forest Investigative Site 1106
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Rhode Island
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E. Providence, Rhode Island, Forente stater, 02914
- Forest Investigative Site 1089
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South Carolina
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Spartanburg, South Carolina, Forente stater, 29303
- Forest Investigative Site 1121
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Texas
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San Antonio, Texas, Forente stater, 78215
- Forest Investigative Site 1498
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Waco, Texas, Forente stater, 76712
- Forest Investigative Site 1129
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Understand the study procedures and be willing to participate in the study as indicated by signing the ICF and HIPAA form
- Be male or female aged 40 to 80 years, inclusive
- Have a diagnosis of stable, moderate to severe COPD (stages II and III) as defined by guidelines of the Global Initiative for Chronic Obstructive Lung Disease (2008)
- Be a current or former cigarette smoker with a smoking history of at least 10 pack-years
- Have post-albuterol/salbutamol FEV1 values ≥ 30% and < 80% of the predicted value. FEV1 will be measured at the Screening Visit (Visit 1) between 10 and 15 minutes after inhalation of albuterol/salbutamol.
- Have post-albuterol/salbutamol FEV1/FVC values < 70% (ie, 100 × post- albuterol/salbutamol FEV1/FVC < 70%).
- If female, be at least 1 year postmenopausal or surgically sterile (defined as having a hysterectomy or tubal ligation). Women of childbearing potential must have a negative serum β-human chorionic gonadotropin pregnancy test at screening
- Be in good stable health (as judged by the Investigator) other than the COPD, based on medical history, physical examination, ECG, spirometry, and clinical laboratory data evaluations
- Have COPD symptoms and FEV1 values at the time of randomization that are stable compared with those at Screening (Visit 1), according to the Investigator's medical judgment
Exclusion Criteria:
- Have been hospitalized for an acute COPD exacerbation within 3 months before screening
- Have any respiratory tract infection (including the upper respiratory tract) or signs of a COPD exacerbation or respiratory infection in the 6 weeks before Screening (Visit 1).
- Have any clinically significant respiratory conditions other than COPD
- Have a history or presence of asthma verified from medical records
- Have used theophylline (including long-acting theophylline) within the previous 3 months before study entry
- Have Stage II hypertension, defined as systolic pressure of 160 and above, and diastolic pressure of 100 and above
- Chronic use of oxygen therapy ≥ 15 hours a day
- Have a history, current diagnosis, or presence of exercise-induced bronchospasm
- Have a body mass index ≥ 40 kg/m2
- Have participated in an pulmonary rehabilitation program within the previous 3 months
- Have clinically significant cardiovascular conditions
- Have uncontrolled infection resulting from human immunodeficiency virus and/or active hepatitis
- Have symptomatic prostatic hypertrophy and/or bladder neck obstruction.
- Have narrow-angle glaucoma
- Have a history of hypersensitivity reaction (including report of paradoxical bronchospasm) to inhaled anticholinergics (including aclidinium bromide), β2 adrenergic agonists, or any other inhaled medication or any component thereof
- Have a QTcB, as indicated in the centralized reading report, above 470 msec in the resting ECGs performed at Screening (Visit 1) and/or patients who are using medications that may prolong the QT interval
- Have clinically relevant abnormalities in the results of clinical laboratory tests, in ECG parameters other than QTc, in results of the physical examination,
- Have any concurrent medical condition that, in the judgment of the Investigator, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being
- Do not maintain regular day/night, waking/sleeping cycles (eg, patients with history of sleep apnea syndrome or any disease related with sleep disturbances such as restless legs syndrome or somnambulism)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Aclidinium 400 μg / Formoterol 12 μg
Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
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Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
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Eksperimentell: Aclidinium 400 μg / formoterol 6 μg
Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
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Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
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Eksperimentell: Aclidinium 400 μg
Aclidinium bromide 400 μg administered twice-daily (BID)
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Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.
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Aktiv komparator: Formoterol 12 μg
Formoterol fumarate 12 μg twice-daily
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Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.
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Placebo komparator: Placebo
Placebo twice-daily
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Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)
Tidsramme: 0 to 12 hours post-dose on Day 14
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0 to 12 hours post-dose on Day 14
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Tidsramme: Day 14
|
Day 14
|
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Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)
Tidsramme: Day 14
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Day 14
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2009
Primær fullføring (Faktiske)
1. august 2010
Studiet fullført (Faktiske)
1. august 2010
Datoer for studieregistrering
Først innsendt
13. januar 2010
Først innsendt som oppfylte QC-kriteriene
13. januar 2010
Først lagt ut (Anslag)
14. januar 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. februar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. januar 2017
Sist bekreftet
1. januar 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Lungesykdommer
- Lungesykdommer, obstruktiv
- Lungesykdom, kronisk obstruktiv
- Fysiologiske effekter av legemidler
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Adrenerge agonister
- Bronkodilatatorer
- Anti-astmatiske midler
- Luftveismidler
- Adrenerge beta-2-reseptoragonister
- Adrenerge beta-agonister
- Formoterolfumarat
Andre studie-ID-numre
- LAC-MD-27
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .