- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00139932
Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272)
22. marts 2017 opdateret af: Merck Sharp & Dohme LLC
A Double-Blind Randomized, Parallel-Group, Multicenter Clinical Study to Compare the Efficacy and Tolerability of Tiotropium Bromide Alone vs. the Co-Administration of Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD
This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
255
Fase
- Fase 4
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subjects must have a clinical history of COPD.
- Subjects must be current cigarette smokers or ex-smokers who stopped smoking at least 3 months prior to screening visit (V1). Subjects must have a smoking history of at least 10 pack-years (20 cigarettes per pack). Pack-years are calculated by multiplying the average packs of cigarettes smoked per day times the number of years.
- Subjects on stable inhaled corticosteroids are allowed to be enrolled and to remain on the treatment throughout the study.
- Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules.
- Subjects must agree to inform their usual treating physician of their participation in this study.
- Female subjects of childbearing potential must have a negative urine pregnancy test prior to the randomization of the study
- Nonpregnant women of childbearing potential must be using a medically acceptable, adequate form of birth control.
Exclusion Criteria:
- Subjects have a current or past history of clinically relevant asthma.
- Subjects quit smoking less than 3 months prior to the Screening visit (V1).
- Subjects have required ventilator support for respiratory failure within the last year.
- Subjects have clinically significant lung disease other than COPD, e.g., bronchiectasis, sarcoidosis, pulmonary fibrosis, tuberculosis, etc.
- Subjects have undergone lobectomy, pneumonectomy or lung volume reduction surgery.
- Subjects have had lung cancer diagnosed or treated within the last five years.
- Subjects require nasal continuous positive airway pressure (CPAP) or bi-level positive airway pressure (Bi-PAP).
- Subjects have initiated pulmonary rehabilitation within the past 3 months.
- Subjects use oxygen >= 2 liters per minute for > 2 hours per day.
- Subjects require chronic or prophylactic treatment with antibiotics.
- Subjects have significant renal, hepatic, cardiovascular (including cor pulmonale), metabolic, neurologic, hematologic, gastrointestinal, cerebrovascular or other significant medical illness or disorder which, in the judgment of the Investigator, may interfere with the study or require treatment which may affect the evaluation of efficacy and safety of the study drug.
- Subjects have clinically significant abnormalities on chest x-ray (other than evidence of COPD) at the Screening visit or within the previous year.
- Women are pregnant or breast-feeding.
- Subjects cannot adhere to the concomitant medications restrictions and prohibitions.
- Subjects have used any investigational product within 30 days, or 3 months for any biologic of unknown half-life, prior to the Baseline Visit (V3).
- Subjects are part of the staff or a family member of the staff personnel directly involved with this study.
- Subjects have chronic narrow-angle glaucoma.
- Subjects have symptomatic prostatic hyperplasia or bladder-neck obstruction.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
effects of tiotropium bromide alone vs.the effect of tiotropium bromide and formoterol fumarate
Tidsramme: 12 weeks
|
To compare the effects of tiotropium bromide alone vs. the effects of co-administration of tiotropium bromide and formoterol fumarate on the change from baseline of the normalized area under the time curve (AUC) for FEV1 for the 0 hour to 4 hours post-morning dose at the last study visit.
|
12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2005
Primær færdiggørelse (Faktiske)
21. november 2006
Studieafslutning (Faktiske)
21. november 2006
Datoer for studieregistrering
Først indsendt
30. august 2005
Først indsendt, der opfyldte QC-kriterier
30. august 2005
Først opslået (Skøn)
31. august 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Lungesygdomme
- Lungesygdomme, obstruktiv
- Lungesygdom, kronisk obstruktiv
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Adrenerge agonister
- Bronkodilatatorer
- Anti-astmatiske midler
- Respiratoriske midler
- Adrenerge beta-2-receptoragonister
- Adrenerge beta-agonister
- Formoterolfumarat
Andre undersøgelses-id-numre
- P04272
Plan for individuelle deltagerdata (IPD)
Studiedata/dokumenter
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med formoterol fumarate
-
Swiss Federal Institute of TechnologyUniversity of Zurich; University Children's Hospital, Zurich; Jomo Kenyatta...Afsluttet
-
Swiss Federal Institute of TechnologyAfsluttet
-
University Health Network, TorontoAktiv, ikke rekrutterendeAkut myeloid leukæmi | Myelodysplastiske syndromer | Tilbagefaldende kræft | Ildfast kræftCanada
-
Swiss Federal Institute of TechnologyBurgerstein VitamineAfsluttet
-
University of NebraskaIkke rekrutterer endnuPerifer arteriel sygdom | Perifere vaskulære sygdomme | Perifer arteriel okklusiv sygdom | Perifer arteriesygdomForenede Stater
-
Galapagos NVAfsluttet
-
Sunnybrook Health Sciences CentreAfsluttetLivmoderhalskræft | Anæmi | Livmoderhalskræft | LivmoderkræftCanada
-
Isabelle Herter-AeberliBurgerstein VitamineAfsluttet
-
National Institutes of Health (NIH)Afsluttet
-
University Hospital, MontpellierRekruttering