ID

41647

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 (Subject-Completed Rating Scales & Questionnaires) is to be filled out at Visit 2, 4 and 6 and/or in case of Early Withdrawal.

Link

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

Stichworte

Versionen (1)
  1. 01.12.20 01.12.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

1. Dezember 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

Subject-Completed Rating Scales & Questionnaires

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identification number
Beschreibung

Subject identification number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit type
Beschreibung

Visit type

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Date of visit/assessment
Beschreibung

Date of visit/assessment

Datentyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Subject-completed Rating Scales & Questionnaires
Beschreibung

Subject-completed Rating Scales & Questionnaires

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0034394
UMLS CUI-3
C0030705
UMLS CUI-4
C0205197
Chronic Respiratory Questionnaire Self-administered Standardized Activities completed?
Beschreibung

Chronic Respiratory Questionnaire Self-administered Standardized Activities completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4289790
UMLS CUI [1,2]
C0205197
Chronic Respiratory Questionnaire Self-administered Standardized Activities Result
Beschreibung

Chronic Respiratory Questionnaire Self-administered Standardized Activities Result

Datentyp

text

Alias
UMLS CUI [1,1]
C4289790
UMLS CUI [1,2]
C1274040
Quick Inventory of Depressive Symptomatology (16-item) (Self-report) (QIDS-SR16) completed?
Beschreibung

Quick Inventory of Depressive Symptomatology (16-item) (Self-report) (QIDS-SR16) completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4331197
UMLS CUI [1,2]
C0205197
Quick Inventory of Depressive Symptomatology (16-item) (Self-report) (QIDS-SR16) Result
Beschreibung

Quick Inventory of Depressive Symptomatology (16-item) (Self-report) (QIDS-SR16) Result

Datentyp

text

Alias
UMLS CUI [1,1]
C4331197
UMLS CUI [1,2]
C1274040
Hospital Anxiety And Depression Scale (HADS) completed
Beschreibung

Hospital Anxiety And Depression Scale (HADS) completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3539657
UMLS CUI [1,2]
C0205197
Hospital Anxiety And Depression Scale (HADS) Result
Beschreibung

Hospital Anxiety And Depression Scale (HADS) Result

Datentyp

text

Alias
UMLS CUI [1,1]
C3539657
UMLS CUI [1,2]
C1274040
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Ähnliche Modelle

Subject-Completed Rating Scales & Questionnaires

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Item
Visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Visit 2 (2)
CL Item
Visit 4 (4)
CL Item
Visit 6 (6)
CL Item
Early Withdrawal (EW)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Subject-completed Rating Scales & Questionnaires
C0681889 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C0030705 (UMLS CUI-3)
C0205197 (UMLS CUI-4)
Chronic Respiratory Questionnaire Self-administered Standardized Activities completed
Item
Chronic Respiratory Questionnaire Self-administered Standardized Activities completed?
boolean
C4289790 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Chronic Respiratory Questionnaire Self-administered Standardized Activities Result
Item
Chronic Respiratory Questionnaire Self-administered Standardized Activities Result
text
C4289790 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Quick Inventory of Depressive Symptomatology (16-item) (Self-report) (QIDS-SR16) completed
Item
Quick Inventory of Depressive Symptomatology (16-item) (Self-report) (QIDS-SR16) completed?
boolean
C4331197 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Quick Inventory of Depressive Symptomatology (16-item) (Self-report) (QIDS-SR16) Result
Item
Quick Inventory of Depressive Symptomatology (16-item) (Self-report) (QIDS-SR16) Result
text
C4331197 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Hospital Anxiety And Depression Scale (HADS) completed
Item
Hospital Anxiety And Depression Scale (HADS) completed
boolean
C3539657 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Hospital Anxiety And Depression Scale (HADS) Result
Item
Hospital Anxiety And Depression Scale (HADS) Result
text
C3539657 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
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