ID

41561

Description

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 (COPD and Smoking History) is to be filled out during the study.

Link

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

Keywords

Versions (1)
  1. 11/11/20 11/11/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 11, 2020

DOI

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License

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

English

COPD and Smoking History

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identification number
Description

Subject identification number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Description

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Duration of COPD
Description

Duration of COPD

Alias
UMLS CUI-1
C0872146
UMLS CUI-2
C0024117
Duration in years
Description

This item is optional

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1,1]
C0872146
UMLS CUI [1,2]
C0024117
years
Duration in months
Description

This item is optional

Data type

integer

Measurement units
  • months
Alias
UMLS CUI [1,1]
C0872146
UMLS CUI [1,2]
C0024117
months
History of COPD Exacerbations
Description

History of COPD Exacerbations

Alias
UMLS CUI-1
C0740304
UMLS CUI-2
C0262926
Number of exacerbations in the last [12 months] that required oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
Description

If none, enter 0 (zero) 'oral corticosteroids', 'systemic corticosteroids', 'corticosteroids' and/or 'antibiotics' are all acceptable options

Data type

integer

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0740304
UMLS CUI [1,3]
C0449788
UMLS CUI [1,4]
C2825233
UMLS CUI [1,5]
C0019993
UMLS CUI [1,6]
C1611645
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0740304
UMLS CUI [2,3]
C0449788
UMLS CUI [2,4]
C0574135
UMLS CUI [2,5]
C0019993
UMLS CUI [2,6]
C1611645
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C0740304
UMLS CUI [3,3]
C0449788
UMLS CUI [3,4]
C0003232
UMLS CUI [3,5]
C0019993
UMLS CUI [3,6]
C1611645
Number of exacerbations in the last [12 months] that required hospitalisation.
Description

If none, enter 0 (zero)

Data type

integer

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0740304
UMLS CUI [1,3]
C0449788
UMLS CUI [1,4]
C1708385
COPD type
Description

COPD type

Alias
UMLS CUI-1
C0024117
UMLS CUI-2
C0332307
COPD type: chronic bronchitis
Description

Optional item to be included ONLY for COPD studies and ONLY IF specified in the protocol.

Data type

boolean

Alias
UMLS CUI [1,1]
C0008677
UMLS CUI [1,2]
C0024117
COPD type: Emphysema
Description

Optional item to be included ONLY for COPD studies and ONLY IF specified in the protocol.

Data type

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0034067
Smoking History
Description

Smoking History

Alias
UMLS CUI-1
C1519384
What is the subject's history of tobacco use?
Description

History of tobacco use

Data type

integer

Alias
UMLS CUI [1]
C0841002
Average number of cigarettes smoked per pay
Description

Average number of cigarettes per day

Data type

integer

Measurement units
  • cigarettes per day
Alias
UMLS CUI [1,1]
C3694146
UMLS CUI [1,2]
C1510992
cigarettes per day
Number of years the subject has smoked
Description

Years smoked

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1]
C3694955
years
Number of pack years
Description

This item will be calculated by InForm using the following formula: Average number of cigarettes smoked per day divided by 20 and then multiplied by number of years smoked. Round up/down to nearest integer.

Data type

integer

Alias
UMLS CUI [1]
C1277691
Substance Use Type
Description

[hidden] This item will be calculated by InForm

Data type

text

Alias
UMLS CUI [1,1]
C0439861
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0332307
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Similar models

COPD and Smoking History

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Duration of COPD
C0872146 (UMLS CUI-1)
C0024117 (UMLS CUI-2)
COPD Duration
Item
Duration in years
integer
C0872146 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
COPD Duration
Item
Duration in months
integer
C0872146 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
Item Group
History of COPD Exacerbations
C0740304 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Number of recent COPD exacerbations requiring corticosteroids (oral/systemic) and/or antibiotics, not involving hospitalisation
Item
Number of exacerbations in the last [12 months] that required oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
integer
C0332185 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C2825233 (UMLS CUI [1,4])
C0019993 (UMLS CUI [1,5])
C1611645 (UMLS CUI [1,6])
C0332185 (UMLS CUI [2,1])
C0740304 (UMLS CUI [2,2])
C0449788 (UMLS CUI [2,3])
C0574135 (UMLS CUI [2,4])
C0019993 (UMLS CUI [2,5])
C1611645 (UMLS CUI [2,6])
C0332185 (UMLS CUI [3,1])
C0740304 (UMLS CUI [3,2])
C0449788 (UMLS CUI [3,3])
C0003232 (UMLS CUI [3,4])
C0019993 (UMLS CUI [3,5])
C1611645 (UMLS CUI [3,6])
Number of recent COPD exacerbations requiring hospitalisation
Item
Number of exacerbations in the last [12 months] that required hospitalisation.
integer
C0332185 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C1708385 (UMLS CUI [1,4])
Item Group
COPD type
C0024117 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
COPD type chronic bronchitis
Item
COPD type: chronic bronchitis
boolean
C0008677 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
COPD type Emphysema
Item
COPD type: Emphysema
boolean
C0024117 (UMLS CUI [1,1])
C0034067 (UMLS CUI [1,2])
Item Group
Smoking History
C1519384 (UMLS CUI-1)
Item
What is the subject's history of tobacco use?
integer
C0841002 (UMLS CUI [1])
History of tobacco use
Code List
What is the subject's history of tobacco use?
CL Item
Current smoker (2)
CL Item
Former smoker (3)
Average number of cigarettes per day
Item
Average number of cigarettes smoked per pay
integer
C3694146 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
Years smoked
Item
Number of years the subject has smoked
integer
C3694955 (UMLS CUI [1])
Number of pack years
Item
Number of pack years
integer
C1277691 (UMLS CUI [1])
Substance Use Type
Item
Substance Use Type
text
C0439861 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
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