ID

41470

Descrição

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 (Vital Signs) is to be filled out at the Screening (Visit 1).

Link

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

Palavras-chave

  1. 21/10/2020 21/10/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

21 de outubro de 2020

DOI

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Licença

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

  1. StudyEvent: ODM
    1. Vital Signs
Administrative Data
Descrição

Administrative Data

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

Date of visit/assessment

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Subject Identification Number
Descrição

Subject Identification Number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Vital Signs
Descrição

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Descrição

Height

Tipo de dados

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descrição

Weight

Tipo de dados

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Descrição

Item to be calculated as: Weight in kilograms divided by the square of height in meters. BMI cannot be >=40 kg/m^2

Tipo de dados

float

Unidades de medida
  • kg/m^2
Alias
UMLS CUI [1]
C1305855
kg/m^2

Similar models

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
Vital Signs
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Mass Index
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])

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