ID

41465

Beschreibung

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Demography) is to be filled out at the Screening (Visit 1).

Link

https://clinicaltrials.gov/ct2/show/NCT00784550

Stichworte

Versionen (1)
  1. 20.10.20 20.10.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Oktober 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

Englisch

Demography

1 Formulare  
  1. StudyEvent: ODM
    1. Demography
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Date of visit/assessment
Beschreibung

Date of visit/assessment

Datentyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Subject identification number
Beschreibung

Subject identification number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry: African American/African Heritage
Beschreibung

Geographic Ancestry: African American/African Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0085756
UMLS CUI [3]
C0027567
Geographic Ancestry: American Indian or Alaskan Native
Beschreibung

Geographic Ancestry: American Indian or Alaskan Native

Datentyp

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C1515945
Geographic Ancestry: Asian - Central/South Asian Heritage
Beschreibung

Geographic Ancestry: Asian - Central/South Asian Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0238696
UMLS CUI [3]
C1519427
Geographic Ancestry: Asian - East Asian Heritage
Beschreibung

Geographic Ancestry: Asian - East Asian Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C4540996
Geographic Ancestry: Asian - Japanese Heritage
Beschreibung

Geographic Ancestry: Asian - Japanese Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C1556094
Geographic Ancestry: Asian - South East Asian Heritage
Beschreibung

Geographic Ancestry: Asian - South East Asian Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0238697
Geographic Ancestry: Native Hawaiian or Other Pacific Islander
Beschreibung

Geographic Ancestry: Native Hawaiian or Other Pacific Islander

Datentyp

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C1513907
Geographic Ancestry: White - Arabic/North African Heritage
Beschreibung

Geographic Ancestry: White - Arabic/North African Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0238604
UMLS CUI [3]
C2698217
Geographic Ancestry: White - White/Caucasian/European Heritage
Beschreibung

Geographic Ancestry: White - White/Caucasian/European Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0043157
UMLS CUI [3]
C1535514
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Ähnliche Modelle

Demography

1 Formulare
  1. StudyEvent: ODM
    1. Demography
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic ot Latino (1)
CL Item
Not Hispanic or Latino (2)
Geographic Ancestry: African American/African Heritage
Item
Geographic Ancestry: African American/African Heritage
boolean
C3841890 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
C0027567 (UMLS CUI [3])
Geographic Ancestry: American Indian or Alaskan Native
Item
Geographic Ancestry: American Indian or Alaskan Native
boolean
C3841890 (UMLS CUI [1])
C1515945 (UMLS CUI [2])
Geographic Ancestry: Asian - Central/South Asian Heritage
Item
Geographic Ancestry: Asian - Central/South Asian Heritage
boolean
C3841890 (UMLS CUI [1])
C0238696 (UMLS CUI [2])
C1519427 (UMLS CUI [3])
Geographic Ancestry: Asian - East Asian Heritage
Item
Geographic Ancestry: Asian - East Asian Heritage
boolean
C3841890 (UMLS CUI [1])
C4540996 (UMLS CUI [2])
Geographic Ancestry: Asian - Japanese Heritage
Item
Geographic Ancestry: Asian - Japanese Heritage
boolean
C3841890 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
Geographic Ancestry: Asian - South East Asian Heritage
Item
Geographic Ancestry: Asian - South East Asian Heritage
boolean
C3841890 (UMLS CUI [1])
C0238697 (UMLS CUI [2])
Geographic Ancestry: Native Hawaiian or Other Pacific Islander
Item
Geographic Ancestry: Native Hawaiian or Other Pacific Islander
boolean
C3841890 (UMLS CUI [1])
C1513907 (UMLS CUI [2])
Geographic Ancestry: White - Arabic/North African Heritage
Item
Geographic Ancestry: White - Arabic/North African Heritage
boolean
C3841890 (UMLS CUI [1])
C0238604 (UMLS CUI [2])
C2698217 (UMLS CUI [3])
Geographic Ancestry: White - White/Caucasian/European Heritage
Item
Geographic Ancestry: White - White/Caucasian/European Heritage
boolean
C3841890 (UMLS CUI [1])
C0043157 (UMLS CUI [2])
C1535514 (UMLS CUI [3])
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