ID
41465
Beschrijving
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
Trefwoorden
Versies (1)
- 20-10-20 20-10-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 oktober 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550
Demography
- StudyEvent: ODM
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Ethnicity
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Geographic Ancestry: African American/African Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C0085756
- UMLS CUI [3]
- C0027567
Beschrijving
Geographic Ancestry: American Indian or Alaskan Native
Datatype
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C1515945
Beschrijving
Geographic Ancestry: Asian - Central/South Asian Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C0238696
- UMLS CUI [3]
- C1519427
Beschrijving
Geographic Ancestry: Asian - East Asian Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C4540996
Beschrijving
Geographic Ancestry: Asian - Japanese Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C1556094
Beschrijving
Geographic Ancestry: Asian - South East Asian Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C0238697
Beschrijving
Geographic Ancestry: Native Hawaiian or Other Pacific Islander
Datatype
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C1513907
Beschrijving
Geographic Ancestry: White - Arabic/North African Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C0238604
- UMLS CUI [3]
- C2698217
Beschrijving
Geographic Ancestry: White - White/Caucasian/European Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C3841890
- UMLS CUI [2]
- C0043157
- UMLS CUI [3]
- C1535514
Similar models
Demography
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0085756 (UMLS CUI [2])
C0027567 (UMLS CUI [3])
C1515945 (UMLS CUI [2])
C0238696 (UMLS CUI [2])
C1519427 (UMLS CUI [3])
C4540996 (UMLS CUI [2])
C1556094 (UMLS CUI [2])
C0238697 (UMLS CUI [2])
C1513907 (UMLS CUI [2])
C0238604 (UMLS CUI [2])
C2698217 (UMLS CUI [3])
C0043157 (UMLS CUI [2])
C1535514 (UMLS CUI [3])