ID

41559

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 (COPD Exacerbations) is to be filled out during the study to document every COPD exacerbation during the trial.

Link

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

Stichworte

Versionen (1)
  1. 11.11.20 11.11.20 -
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GlaxoSmithKline

Hochgeladen am

11. November 2020

DOI

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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

COPD Exacerbations

1 Formulare  
  1. StudyEvent: ODM
    1. COPD Exacerbations
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
COPD exacerbation symptoms
Beschreibung

COPD exacerbation symptoms

Alias
UMLS CUI-1
C0740304
UMLS CUI-2
C1457887
Date of onset
Beschreibung

COPD exacerbation symptom Date of onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0574845
Dyspnea
Beschreibung

COPD exacerbation symptom: Dyspnea

Datentyp

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0013404
Increased Sputum
Beschreibung

COPD exacerbation symptom: Increased Sputum

Datentyp

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0858642
Increased cough
Beschreibung

COPD exacerbation symptom: Increased Cough

Datentyp

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0574067
COPD exacerbations
Beschreibung

COPD exacerbations

Alias
UMLS CUI-1
C0740304
Date of onset
Beschreibung

COPD exacerbation Date of onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0574845
Outcome
Beschreibung

COPD exacerbation outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C1624730
If resolved, provide End Date
Beschreibung

COPD exacerbation outcome: resolved, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C3714811
UMLS CUI [1,3]
C0806020
If fatal, record Date of Death
Beschreibung

COPD exacerbation outcome: fatal, Date of Death

Datentyp

date

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C1302234
UMLS CUI [2]
C1148348
Severity
Beschreibung

COPD exacerbation severity

Datentyp

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0439793
Was the subject withdrawn due to this exacerbation?
Beschreibung

Withdrawal due to COPD exacerbation

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0740304
Primary cause of exacerbation?
Beschreibung

Cause of COPD exacerbation

Datentyp

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0085978
Were systemic/oral corticosteroids taken for the exacerbation?
Beschreibung

The words 'systemic' and 'oral' are both optional. Either can be used or both removed depending upon specification of corticosteroid data collection in the protocol.

Datentyp

text

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0740304
UMLS CUI [2,1]
C0574135
UMLS CUI [2,2]
C0740304
Were antibiotics taken for the exacerbation?
Beschreibung

Antibiotics for COPD exacerbation

Datentyp

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0003232
Was the subject hospitalised due to this exacerbation?
Beschreibung

Hospitalisation COPD exacerbation

Datentyp

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0019993
Contact method/treatment site for exacerbations: Number of physician office/practice visits
Beschreibung

If none, enter 0 (zero)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0031834
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0449788
Contact method/treatment site for exacerbations: Number of urgent care/outpatient clinic visits
Beschreibung

If none, enter 0 (zero)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0008952
UMLS CUI [1,3]
C0545084
UMLS CUI [1,4]
C0449788
UMLS CUI [2,1]
C0740304
UMLS CUI [2,2]
C1551285
UMLS CUI [2,3]
C0008952
UMLS CUI [2,4]
C0449788
Contact method/treatment site for exacerbations: Number of emergency room visits
Beschreibung

If none, enter 0 (zero)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0583237
UMLS CUI [1,3]
C0449788
Contact method/treatment site for exacerbations: Number of inpatient hospitalisation days: ICU
Beschreibung

If none, enter 0 (zero)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C3694481
UMLS CUI [1,3]
C0021708
Contact method/treatment site for exacerbations: Number of inpatient hospitalisation days: General ward
Beschreibung

If none, enter 0 (zero)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C3694481
UMLS CUI [1,3]
C0043030
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Ähnliche Modelle

COPD Exacerbations

1 Formulare
  1. StudyEvent: ODM
    1. COPD Exacerbations
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
COPD exacerbation symptoms
C0740304 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
COPD exacerbation symptom Date of onset
Item
Date of onset
date
C0740304 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Item
Dyspnea
text
C0740304 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0013404 (UMLS CUI [2])
COPD exacerbation symptom: Dyspnea
Code List
Dyspnea
CL Item
Yes (Y)
CL Item
No (N)
Item
Increased Sputum
text
C0740304 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0858642 (UMLS CUI [2])
COPD exacerbation symptom: Dyspnea
Code List
Increased Sputum
CL Item
Yes (Y)
CL Item
No (N)
Item
Increased cough
text
C0740304 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0574067 (UMLS CUI [2])
COPD exacerbation symptom: Dyspnea
Code List
Increased cough
CL Item
Yes (Y)
CL Item
No (N)
Item Group
COPD exacerbations
C0740304 (UMLS CUI-1)
COPD exacerbation Date of onset
Item
Date of onset
date
C0740304 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Outcome
integer
C0740304 (UMLS CUI [1,1])
C1624730 (UMLS CUI [1,2])
COPD exacerbation outcome
Code List
Outcome
CL Item
Resolved, provide End Date (1)
CL Item
Fatal, record Date of Death (2)
CL Item
Not resolved (3)
COPD exacerbation outcome: resolved, End Date
Item
If resolved, provide End Date
date
C0740304 (UMLS CUI [1,1])
C3714811 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
COPD exacerbation outcome: fatal, Date of Death
Item
If fatal, record Date of Death
date
C0740304 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
Item
Severity
text
C0740304 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
COPD exacerbation severity
Code List
Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Was the subject withdrawn due to this exacerbation?
text
C0422727 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
COPD exacerbation symptom: Dyspnea
Code List
Was the subject withdrawn due to this exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item
Primary cause of exacerbation?
text
C0740304 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Cause of COPD exacerbation
Code List
Primary cause of exacerbation?
CL Item
Cold air/cold weather (1)
CL Item
Tobacco smoke (2)
CL Item
Upper respiratory infection (3)
CL Item
Air pollution (4)
CL Item
Allergy (5)
CL Item
Exercise (6)
CL Item
Stress/Emotions (7)
CL Item
Beta-blockers (8)
CL Item
Aspirin (9)
CL Item
Other NSAIDS (10)
CL Item
Withholding or reducing COPD meds (12)
CL Item
Unknown etiology (13)
CL Item
Lack of efficacy (14)
CL Item
Lower respiratory infection (15)
CL Item
Common cold (16)
CL Item
Upper respiratory infection other than common cold (17)
CL Item
Other (OT)
Item
Were systemic/oral corticosteroids taken for the exacerbation?
text
C2825233 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
C0574135 (UMLS CUI [2,1])
C0740304 (UMLS CUI [2,2])
COPD exacerbation symptom: Dyspnea
Code List
Were systemic/oral corticosteroids taken for the exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were antibiotics taken for the exacerbation?
text
C0740304 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
COPD exacerbation symptom: Dyspnea
Code List
Were antibiotics taken for the exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the subject hospitalised due to this exacerbation?
text
C0740304 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
COPD exacerbation symptom: Dyspnea
Code List
Was the subject hospitalised due to this exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Number of physician office visits due to COPD exacerbation
Item
Contact method/treatment site for exacerbations: Number of physician office/practice visits
integer
C0740304 (UMLS CUI [1,1])
C0031834 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,4])
Number of urgent care/outpatient clinic visits due to COPD exacerbation
Item
Contact method/treatment site for exacerbations: Number of urgent care/outpatient clinic visits
integer
C0740304 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0545084 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,4])
C0740304 (UMLS CUI [2,1])
C1551285 (UMLS CUI [2,2])
C0008952 (UMLS CUI [2,3])
C0449788 (UMLS CUI [2,4])
Number of emergency room visits due to COPD exacerbation
Item
Contact method/treatment site for exacerbations: Number of emergency room visits
integer
C0740304 (UMLS CUI [1,1])
C0583237 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of inpatient hospitalisation days at ICU due to COPD exacerbation
Item
Contact method/treatment site for exacerbations: Number of inpatient hospitalisation days: ICU
integer
C0740304 (UMLS CUI [1,1])
C3694481 (UMLS CUI [1,2])
C0021708 (UMLS CUI [1,3])
Number of inpatient hospitalisation days at general ward due to COPD exacerbation
Item
Contact method/treatment site for exacerbations: Number of inpatient hospitalisation days: General ward
integer
C0740304 (UMLS CUI [1,1])
C3694481 (UMLS CUI [1,2])
C0043030 (UMLS CUI [1,3])
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