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Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

3. april 2017 opdateret af: AstraZeneca

A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).

Studieoversigt

Status

Afsluttet

Betingelser

Kronisk obstruktiv lungesygdom

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

590

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35209
    - Forest Investigative Site 1162
  - Birmingham, Alabama, Forenede Stater, 35209
    - Forest Investigative Site 1493
  - Birmingham, Alabama, Forenede Stater, 35235
    - Forest Investigative Site 1620
  - Mobile, Alabama, Forenede Stater, 36608
    - Forest Investigative Site 1127
- Arizona
  - Chandler, Arizona, Forenede Stater, 85224
    - Forest Investigative Site 1613
  - Peoria, Arizona, Forenede Stater, 85381
    - Forest Investigative Site 1623
  - Phoenix, Arizona, Forenede Stater, 85018
    - Forest Investigative Site 1379
  - Phoenix, Arizona, Forenede Stater, 85012
    - Forest Investigative Site 1582
  - Phoenix, Arizona, Forenede Stater, 85020
    - Forest Investigative Site 1581
  - Phoenix, Arizona, Forenede Stater, 85050
    - Forest Investigative Site 1571
- Arkansas
  - Fort Smith, Arkansas, Forenede Stater, 72901
    - Forest Investigative Site 1596
- California
  - Encinitas, California, Forenede Stater, 92024
    - Forest Investigative Site 1547
  - Lakewood, California, Forenede Stater, 90712
    - Forest Investigative Site 1088
  - Los Angeles, California, Forenede Stater, 90025
    - Forest Investigative Site 1624
  - Los Angeles, California, Forenede Stater, 90048
    - Forest Investigative Site 1927
  - Paramount, California, Forenede Stater, 90723
    - Forest Investigative Site 1388
  - San Diego, California, Forenede Stater, 92128
    - Forest Investigative Site 1503
  - Torrance, California, Forenede Stater, 90505
    - Forest Investigative Site 1374
  - Vista, California, Forenede Stater, 92083
    - Forest Investigative Site 1331
  - Walnut Creek, California, Forenede Stater, 94598
    - Forest Investigative Site 2039
- Colorado
  - Boulder, Colorado, Forenede Stater, 80304
    - Forest Investigative Site 1597
  - Colorado Springs, Colorado, Forenede Stater, 80907
    - Forest Investigative Site 1137
  - Denver, Colorado, Forenede Stater, 80206
    - Forest Investigative Site 0892
  - Fort Collins, Colorado, Forenede Stater, 80528
    - Forest Investigative Site 2037
  - Wheat Ridge, Colorado, Forenede Stater, 80033
    - Forest Investigative Site 1327
  - Wheat Ridge, Colorado, Forenede Stater, 80033
    - Forest Investigative Site 2045
- Connecticut
  - Norwalk, Connecticut, Forenede Stater, 06851
    - Forest Investigative Site 1589
  - Stamford, Connecticut, Forenede Stater, 06902
    - Forest Investigative Site 1598
- Florida
  - Brandon, Florida, Forenede Stater, 33511
    - Forest Investigative Site 1154
  - Brandon, Florida, Forenede Stater, 33511
    - Forest Investigative Site 1944
  - Clearwater, Florida, Forenede Stater, 33765
    - Forest Investigative Site 1152
  - Debary, Florida, Forenede Stater, 32713
    - Forest Investigative Site 1617
  - Debary, Florida, Forenede Stater, 32713
    - Forest Investigative Site 1959
  - Edgewater, Florida, Forenede Stater, 32132
    - Forest Investigative Site 1516
  - Hollywood, Florida, Forenede Stater, 33024
    - Forest Investigative Site 1403
  - Orlando, Florida, Forenede Stater, 32822
    - Forest Investigative Site 1556
  - Ormond Beach, Florida, Forenede Stater, 32174
    - Forest Investigative Site 1542
  - Pensacola, Florida, Forenede Stater, 32504
    - Forest Investigative Site 0974
  - Tampa, Florida, Forenede Stater, 33613
    - Forest Investigative Site 2047
  - Venice, Florida, Forenede Stater, 34292
    - Forest Investigative Site 1565
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30342
    - Forest Investigative Site 0980
  - Atlanta, Georgia, Forenede Stater, 30329
    - Forest Investigative Site 1851
  - Atlanta, Georgia, Forenede Stater, 30342
    - Forest Investigative Site 1567
  - Lawrenceville, Georgia, Forenede Stater, 30046
    - Forest Investigative Site 1607
- Illinois
  - O'Fallon, Illinois, Forenede Stater, 62269
    - Forest Investigative Site 1409
  - River Forest, Illinois, Forenede Stater, 60305
    - Forest Investigative Site 2051
  - Springfield, Illinois, Forenede Stater, 62702
    - Forest Investigative Site 1604
- Indiana
  - Evansville, Indiana, Forenede Stater, 47713
    - Forest Investigative Site 1576
- Iowa
  - Council Bluffs, Iowa, Forenede Stater, 51503
    - Forest Investigative Site 1549
- Kentucky
  - Bowling Green, Kentucky, Forenede Stater, 42101
    - Forest Investigative Site 2033
  - Crescent Springs, Kentucky, Forenede Stater, 41017
    - Forest Investigative Site 2085
  - Louisville, Kentucky, Forenede Stater, 40215
    - Forest Investigative Site 1336
- Louisiana
  - Lafayette, Louisiana, Forenede Stater, 70503
    - Forest Investigative Site 2024
  - New Orleans, Louisiana, Forenede Stater, 70115
    - Forest Investigative Site 1430
  - Sunset, Louisiana, Forenede Stater, 70584
    - Forest Investigative Site 1360
- Maine
  - Auburn, Maine, Forenede Stater, 04210
    - Forest Investigative Site 1566
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21236
    - Forest Investigative Site 1333
  - Columbia, Maryland, Forenede Stater, 21044
    - Forest Investigative Site 1622
  - Towson, Maryland, Forenede Stater, 21204
    - Forest Investigative Site 1590
- Massachusetts
  - Fall River, Massachusetts, Forenede Stater, 02720
    - Forest Investigative Site 1570
  - Haverhill, Massachusetts, Forenede Stater, 01830
    - Forest Investigative Site 1546
  - North Dartmouth, Massachusetts, Forenede Stater, 02747
    - Forest Investigative Site 1029
  - Worcestor, Massachusetts, Forenede Stater, 01605
    - Forest Investigative Site 1595
- Michigan
  - Traverse City, Michigan, Forenede Stater, 49684
    - Forest Investigative Site 1605
- Minnesota
  - Fridley, Minnesota, Forenede Stater, 55432
    - Forest Investigative Site 1527
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Forest Investigative Site 1124
  - Plymouth, Minnesota, Forenede Stater, 55441
    - Forest Investigative Site 1619
- Missouri
  - Chesterfield, Missouri, Forenede Stater, 63017
    - Forest Investigative Site 1587
  - Jefferson City, Missouri, Forenede Stater, 65109
    - Forest Investigative Site 1572
  - St. Louis, Missouri, Forenede Stater, 63141
    - Forest Investigative Site 1399
  - St. Louis, Missouri, Forenede Stater, 63141
    - Forest Investigative Site 1599
- Montana
  - Bozeman, Montana, Forenede Stater, 59718
    - Forest Investigative Site 1831
  - Missoula, Montana, Forenede Stater, 59808
    - Forest Investigative Site 1400
- Nebraska
  - Bellevue, Nebraska, Forenede Stater, 68123
    - Forest Investigative Site 1609
  - Lincoln, Nebraska, Forenede Stater, 68506
    - Forest Investigative Site 1616
  - Omaha, Nebraska, Forenede Stater, 68134
    - Forest Investigative Site 1615
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89183
    - Forest Investigative Site 1562
- New Hampshire
  - Rochester, New Hampshire, Forenede Stater, 03867
    - Forest Investigative Site 1610
- New Jersey
  - Brick, New Jersey, Forenede Stater, 08723
    - Forest Investigative Site 1558
  - Cherry Hill, New Jersey, Forenede Stater, 08003
    - Forest Investigative Site 1559
  - Ocean, New Jersey, Forenede Stater, 07712
    - Forest Investigative Site 1394
  - Summit, New Jersey, Forenede Stater, 07901
    - Forest Investigative Site 2084
- New York
  - Brooklyn, New York, Forenede Stater, 11229
    - Forest Investigative Site 0972
  - New York, New York, Forenede Stater, 10028
    - Forest Investigative Site 1425
  - New York, New York, Forenede Stater, 10016
    - Forest Investigative Site 1163
  - Newburgh, New York, Forenede Stater, 12550
    - Forest Investigative Site 1554
  - Syracuse, New York, Forenede Stater, 13210
    - Forest Investigative Site 1563
- North Carolina
  - Raleigh, North Carolina, Forenede Stater, 27612
    - Forest Investigative Site 1557
  - Shelby, North Carolina, Forenede Stater, 28152
    - Forest Investigative Site 1588
  - Wilmington, North Carolina, Forenede Stater, 28401
    - Forest Investigative Site 1553
  - Winston-Salem, North Carolina, Forenede Stater, 27103
    - Forest Investigative Site 1550
- Ohio
  - Canton, Ohio, Forenede Stater, 44718
    - Forest Investigative Site 1134
  - Cincinnati, Ohio, Forenede Stater, 45242
    - Forest Investigative Site 2028
  - Cincinnati, Ohio, Forenede Stater, 45224
    - Forest Investigative Site 1594
  - Marion, Ohio, Forenede Stater, 43302
    - Forest Investigative Site 1541
  - Toledo, Ohio, Forenede Stater, 43608
    - Forest Investigative Site 1530
  - Zanesville, Ohio, Forenede Stater, 43701
    - Forest Investigative Site 1393
- Oregon
  - Ashland, Oregon, Forenede Stater, 97520
    - Forest Investigative Site 1612
  - Corvallis, Oregon, Forenede Stater, 97330
    - Forest Investigative Site 1575
  - Eugene, Oregon, Forenede Stater, 97404
    - Forest Investigative Site 1081
  - Portland, Oregon, Forenede Stater, 97213
    - Forest Investigative Site 1580
  - Portland, Oregon, Forenede Stater, 97220
    - Forest Investigative Site 1552
- Pennsylvania
  - Beaver, Pennsylvania, Forenede Stater, 15009
    - Forest Investigative Site 1574
  - Beaver, Pennsylvania, Forenede Stater, 15009
    - Forest Investigative Site 1577
  - Bethlehem, Pennsylvania, Forenede Stater, 18020
    - Forest Investigative Site 1126
  - Erie, Pennsylvania, Forenede Stater, 16506
    - Forest Investigative Site 1423
  - Hershey, Pennsylvania, Forenede Stater, 17033
    - Forest Investigative Site 1504
  - Pittsburgh, Pennsylvania, Forenede Stater, 15243
    - Forest Investigative Site 1146
  - Pittsburgh, Pennsylvania, Forenede Stater, 15213
    - Forest Investigative Site 1569
  - Pittsburgh, Pennsylvania, Forenede Stater, 15236
    - Forest Investigative Site 1548
  - Pittsburgh, Pennsylvania, Forenede Stater, 15243
    - Forest Investigative Site 1560
  - Tipton, Pennsylvania, Forenede Stater, 16684
    - Forest Investigative Site 1449
  - Uniontown, Pennsylvania, Forenede Stater, 15401
    - Forest Investigative Site 1564
- Rhode Island
  - Johnston, Rhode Island, Forenede Stater, 02919
    - Forest Investigative Site 1144
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29406
    - Forest Investigative Site 2072
  - Easley, South Carolina, Forenede Stater, 29640
    - Forest Investigative Site 1568
  - Greenville, South Carolina, Forenede Stater, 29615
    - Forest Investigative Site 1506
  - Greer, South Carolina, Forenede Stater, 29651
    - Forest Investigative Site 1601
  - Spartanburg, South Carolina, Forenede Stater, 29303
    - Forest Investigative Site 0900
  - Union, South Carolina, Forenede Stater, 29379
    - Forest Investigative Site 1450
- South Dakota
  - Rapid City, South Dakota, Forenede Stater, 57702
    - Forest Investigative Site 1365
- Texas
  - Arlington, Texas, Forenede Stater, 76012
    - Forest Investigative Site 1440
  - Austin, Texas, Forenede Stater, 78731
    - Forest Investigative Site 1954
  - Dallas, Texas, Forenede Stater, 75231
    - Forest Investigative Site 1155
  - Dallas, Texas, Forenede Stater, 75231
    - Forest Investigative Site 1328
  - El Paso, Texas, Forenede Stater, 79903
    - Forest Investigative Site 1332
  - Fort Worth, Texas, Forenede Stater, 76104
    - Forest Investigative Site 2012
  - Killeen, Texas, Forenede Stater, 76543
    - Forest Investigative Site 1902
  - San Antonio, Texas, Forenede Stater, 78215
    - Forest Investigative Site 1498
  - San Antonio, Texas, Forenede Stater, 78228
    - Forest Investigative Site 1614
  - San Antonio, Texas, Forenede Stater, 78229
    - Forest Investigative Site 1906
  - San Antonio, Texas, Forenede Stater, 78229
    - Forest Investigative Site 2004
- Utah
  - Magna, Utah, Forenede Stater, 84044
    - Forest Investigative Site 1600
- Virginia
  - Abingdon, Virginia, Forenede Stater, 24210
    - Forest Investigative Site 1480
  - Alexandria, Virginia, Forenede Stater, 22304
    - Forest Investigative Site 1579
- Washington
  - Spokane, Washington, Forenede Stater, 99216
    - Forest Investigative Site 1573
  - Spokane, Washington, Forenede Stater, 99204
    - Forest Investigative Site 1142

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:

Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

Exclusion Criteria:

Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
Patients with any clinically significant respiratory conditions other than COPD
Clinical history that suggests that the patient has asthma as opposed to COPD
Chronic use of oxygen therapy ≥ 15 hours/day
Patients with clinically significant cardiovascular conditions
Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
Current diagnosis of cancer other than basal or squamous cell skin cancer

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: Firedobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: 1 Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day	Medicin: Aclidinium Bromide/Formoterol Fumarate Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day
Aktiv komparator: 2 Inhaled formoterol fumarate 12 μg, twice per day	Medicin: Formoterol Fumarate Inhaled formoterol fumarate 12 μg, twice per day

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) Tidsramme: Up to study Week 56 ± 3 days	TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)	Up to study Week 56 ± 3 days

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study Tidsramme: Up to study Week 52	<0.85 x lower limit of normal (LLN) or > 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts >1.15 × ULN for eosinophil, basophil and monocyte counts >1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides <0.85 x LLN or >1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin <0.95 x LLN or >1.05 x ULN for sodium, potassium and chloride Urinary blood, ketones or pH <0.85 x LLN or > 1.15 ULN	Up to study Week 52
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure Tidsramme: Up to study Week 56 ± 3 days	Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline; Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline; Pulse rate ≥ 110 bpm and increase ≥ 15% from baseline or ≤ 50 bpm and decrease ≥15% from baseline	Up to study Week 56 ± 3 days
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline Tidsramme: Up to study Week 56 ± 3 days	Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)	Up to study Week 56 ± 3 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

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

Donohue JF, Soong W, Wu X, Shrestha P, Lei A. Long-term safety of aclidinium bromide/formoterol fumarate fixed-dose combination: Results of a randomized 1-year trial in patients with COPD. Respir Med. 2016 Jul;116:41-8. doi: 10.1016/j.rmed.2016.05.007. Epub 2016 May 7.

Hjælpsomme links

lac-md-32-synopsis

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)

19. september 2011

Primær færdiggørelse (Faktiske)

31. marts 2013

Studieafslutning (Faktiske)

30. april 2013

Datoer for studieregistrering

Først indsendt

19. september 2011

Først indsendt, der opfyldte QC-kriterier

20. september 2011

Først opslået (Skøn)

21. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. april 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

LAC-MD-32

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 Aclidinium Bromide/Formoterol Fumarate

Joincare Pharmaceutical Group Industry Co., Ltd
Livzon Pharmaceutical Group Inc.

Afsluttet

Sikkerhed og effekt af JKN2304 inhalationsopløsning hos patienter med moderat til svær KOL

KOL | KOL (kronisk obstruktiv lungesygdom)

Kina
AstraZeneca

Afsluttet

Effekt og sikkerhed af to faste dosiskombinationer af aclidiniumbromid med formoterolfumarat (ALIGHT-COPD)

Kronisk obstruktiv lungesygdom

Rumænien, Tjekkiet
University of California, Davis
United States Department of Agriculture (USDA)

Rekruttering

Effekter af Goji vs. Fiber på makuladegeneration (GOJI)

Aldersrelateret makuladegeneration

Forenede Stater
Centre Hospitalier Universitaire, Amiens

Rekruttering

Perioperativ inhaleret terapi i kræftfremkaldende thoraxkirurgi hos patienter med høj risiko for postoperative lungekomplikationer (TICTAC)

Thoraxkirurgi | Postoperative lungekomplikationer (PPC'er)

Frankrig
University of Alberta

Afsluttet

Kardiovaskulære konsekvenser af inhaleret korttidsvirkende beta-agonistbrug

Sund og rask

Canada
AstraZeneca
Menarini Group

Afsluttet

Effekt af Aclidinium/Formoterol på lungehyperinflation, træningskapacitet og fysisk aktivitet hos moderat til svær KOL-patienter (ACTIVATE)

Lungesygdom, kronisk obstruktiv

Tyskland, Ungarn, Spanien, Canada
Queen's University
AstraZeneca

Afsluttet

Virkning af aclidinium/formoterol på natlig lungefunktion og morgensymptomer ved kronisk obstruktiv lungesygdom

KOL

Canada
AstraZeneca
Parexel

Rekruttering

En undersøgelse til at undersøge virkningen af budesonid/glycopyrronium/formoterol -fumaratmålet dosisinhalator (BGF MDI) sammenlignet med placebo MDI på hjerte- og lungefunktion hos deltagere med kronisk obstruktiv lungesygdom (KOLS) (ORATOS)

Kronisk obstruktiv lungesygdom | Hyperinflation

Tyskland, Det Forenede Kongerige
AstraZeneca

Afsluttet

Sammenligning af aclidiniumbromid og formoterolfumarat hos patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL)

Lungesygdom, kronisk obstruktiv

Forenede Stater
Sanofi

Rekruttering

Undersøgelse af Lunsekimig (SAR443765) sammenlignet med placebo hos voksne med højrisiko astma (AIRLYMPUS)

Astma

Forenede Stater, Spanien, Italien, Sydafrika, Frankrig, Danmark, Canada, Sverige, Argentina, Israel, Taiwan, Kina, Tyskland, Tyrkiet (Türkiye), Chile, Brasilien, Japan, Belgien, Ungarn, Polen, Rumænien, Det Forenede Kongerige

Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Publikationer og nyttige links

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Aclidinium Bromide/Formoterol Fumarate

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Iran

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer