ID

41562

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 (Medical Conditions) is to be filled out during the study. Record medical history for current conditions only.

Link

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

Stichworte

Versionen (1)
  1. 11.11.20 11.11.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

11. November 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

Medical Conditions

1 Formulare  
  1. StudyEvent: ODM
    1. Medical Conditions
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identification number
Beschreibung

Subject identification number

Datentyp

text

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

Date of visit/assessment

Datentyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Medical Conditions
Beschreibung

Medical Conditions

Alias
UMLS CUI-1
C0262926
Blood and lymphatic system disorders
Beschreibung

Blood and lymphatic system disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0851353
Cardiac disorders
Beschreibung

Cardiac disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0018799
Ear and labyrinth disorders
Beschreibung

Ear and labyrinth disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0851354
Endocrine disorders
Beschreibung

Endocrine disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0014130
Eye disorders
Beschreibung

Eye disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0015397
Gastrointestinal disorders
Beschreibung

Gastrointestinal disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0017178
Hepatobiliary disorders
Beschreibung

Hepatobiliary disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0267792
Immune system disorders
Beschreibung

Immune system disorders

Datentyp

integer

Alias
UMLS CUI [1]
C1334156
Metabolism and nutrition disorders
Beschreibung

Metabolism and nutrition disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0851358
Musculoskeletal and connective tissue disorders
Beschreibung

Musculoskeletal and connective tissue disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0263660
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Beschreibung

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1882062
UMLS CUI [1,2]
C0205183
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0205370
UMLS CUI [4]
C0010709
UMLS CUI [5]
C0032584
Nervous system disorders
Beschreibung

Nervous system disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0027765
Psychiatric disorder
Beschreibung

Psychiatric disorder

Datentyp

integer

Alias
UMLS CUI [1]
C0004936
Renal and urinary disorder
Beschreibung

Renal and urinary disorder

Datentyp

integer

Alias
UMLS CUI [1]
C0042075
UMLS CUI [2]
C0022658
Reproductive system and breast disorders
Beschreibung

Reproductive system and breast disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0851366
Respiratory, thoracic and mediastinal disorders
Beschreibung

Respiratory, thoracic and mediastinal disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0851355
Skin and subcutaneous tissue disorders
Beschreibung

Skin and subcutaneous tissue disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0178298
Vascular disorders
Beschreibung

Vascular disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0042373
Infections and infestations
Beschreibung

Infections and infestations

Datentyp

integer

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0851341
Congenital, familial and genetic disorders
Beschreibung

Congenital, familial and genetic disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0851352
Injury, poisoning and procedural complications
Beschreibung

Injury, poisoning and procedural complications

Datentyp

integer

Alias
UMLS CUI [1]
C0947733
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Medical Conditions

1 Formulare
  1. StudyEvent: ODM
    1. Medical Conditions
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])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Medical Conditions
C0262926 (UMLS CUI-1)
Item
Blood and lymphatic system disorders
integer
C0851353 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Blood and lymphatic system disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Cardiac disorders
integer
C0018799 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Cardiac disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Ear and labyrinth disorders
integer
C0851354 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Ear and labyrinth disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Endocrine disorders
integer
C0014130 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Endocrine disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Eye disorders
integer
C0015397 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Eye disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Gastrointestinal disorders
integer
C0017178 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Gastrointestinal disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Hepatobiliary disorders
integer
C0267792 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Hepatobiliary disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Immune system disorders
integer
C1334156 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Immune system disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Metabolism and nutrition disorders
integer
C0851358 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Metabolism and nutrition disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Musculoskeletal and connective tissue disorders
integer
C0263660 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Musculoskeletal and connective tissue disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Neoplasms benign, malignant and unspecified (including cysts and polyps)
integer
C1882062 (UMLS CUI [1,1])
C0205183 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C0027651 (UMLS CUI [3,1])
C0205370 (UMLS CUI [3,2])
C0010709 (UMLS CUI [4])
C0032584 (UMLS CUI [5])
Blood and lymphatic system disorders
Code List
Neoplasms benign, malignant and unspecified (including cysts and polyps)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Nervous system disorders
integer
C0027765 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Nervous system disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Psychiatric disorder
integer
C0004936 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Psychiatric disorder
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Renal and urinary disorder
integer
C0042075 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Blood and lymphatic system disorders
Code List
Renal and urinary disorder
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Reproductive system and breast disorders
integer
C0851366 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Reproductive system and breast disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Respiratory, thoracic and mediastinal disorders
integer
C0851355 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Respiratory, thoracic and mediastinal disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Skin and subcutaneous tissue disorders
integer
C0178298 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Skin and subcutaneous tissue disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Vascular disorders
integer
C0042373 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Vascular disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Infections and infestations
integer
C0009450 (UMLS CUI [1])
C0851341 (UMLS CUI [2])
Blood and lymphatic system disorders
Code List
Infections and infestations
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Congenital, familial and genetic disorders
integer
C0851352 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Congenital, familial and genetic disorders
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
Injury, poisoning and procedural complications
integer
C0947733 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Injury, poisoning and procedural complications
CL Item
Current (1)
CL Item
No Medical Condition (5)
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