ID

41565

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 (Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome) is to be filled out whenever applicable. In case of suspected pneumonia, pneumonia diagnosis must be confirmed by chest X-ray. Confirmed diagnosis of pneumonia must be recorded as an Adverse Event. A chest X-ray should be obtained for subjects who experience a lower respiratory tract infection requiring treatment with antibiotics for determination of the presence of pneumonia. Ancillary data should represent symptoms from initial presentation.

Link

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

Keywords

Versions (3)
  1. 11/11/20 11/11/20 -
  2. 11/11/20 11/11/20 -
  3. 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

Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome

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
Chest X-ray
Description

Chest X-ray

Alias
UMLS CUI-1
C0039985
Was a chest x-rey performed?
Description

Chest X-ray

Data type

text

Alias
UMLS CUI [1]
C0039985
If No, please comment on why chest x-ray was not obtained
Description

Reason for not obtaining chest x-ray

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C1882120
UMLS CUI [1,3]
C0566251
Date of x-ray
Description

Date of x-ray

Data type

date

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0011008
Was an infiltrate present?
Description

Infiltrate

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
Infiltrate in right upper lobe
Description

Infiltrate right upper lobe

Data type

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261074
Infiltrate in right middle lobe
Description

Infiltrate right middle lobe

Data type

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C0225757
Infiltrate in right lower lobe
Description

Infiltrate right lower lobe

Data type

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261075
Infiltrate in left upper lobe
Description

Infiltrate left upper lobe

Data type

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261076
Infiltrate in lingula
Description

Infiltrate lingula

Data type

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C0225740
Infiltrate left lower lobe
Description

Infiltrate left lower lobe

Data type

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261077
Characterization of infiltrate
Description

Characterization of infiltrate

Data type

integer

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1880022
Was a pleural effusion identified?
Description

Pleural effusion

Data type

integer

Alias
UMLS CUI [1]
C0032227
If pleural effusion was present, please specify location
Description

Pleural effusion location

Data type

integer

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0450429
Was atelectasis present?
Description

Atelectasis

Data type

text

Alias
UMLS CUI [1]
C0004144
Was a lung mass identified?
Description

Lung mass

Data type

text

Alias
UMLS CUI [1]
C0149726
Was cardiomegaly identified?
Description

Cardiomegaly

Data type

text

Alias
UMLS CUI [1]
C0018800
Was pulmonary edema identified?
Description

Pulmonary edema

Data type

text

Alias
UMLS CUI [1]
C0034063
Were air bronchograms identified?
Description

Air bronchogram

Data type

text

Alias
UMLS CUI [1]
C3669021
Enter clinical findings from a radiology report below:
Description

Clinical findings from radiology report

Data type

text

Alias
UMLS CUI [1,1]
C1299496
UMLS CUI [1,2]
C0243095
Cultures and clinical findings
Description

Cultures and clinical findings

Alias
UMLS CUI-1
C0430400
UMLS CUI-2
C0037088
Were any culture results obtained?
Description

Culture results

Data type

text

Alias
UMLS CUI [1,1]
C0430400
UMLS CUI [1,2]
C1274040
If culture results were obtained, please provide Date
Description

Culture results date

Data type

date

Alias
UMLS CUI [1,1]
C0430400
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0011008
If culture results were obtained, please provide pathogen name
Description

Culture result pathogen name

Data type

text

Alias
UMLS CUI [1,1]
C0430400
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0450254
If culture result was obtained, please provide Site
Description

Culture result site

Data type

text

Alias
UMLS CUI [1,1]
C0430400
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C1515974
Temperature <95 F or >= 104 F
Description

Temperature

Data type

text

Alias
UMLS CUI [1]
C0005903
Did the subject have altered mental status?
Description

Altered mental status

Data type

text

Alias
UMLS CUI [1]
C0278061
Respiratory rate > 30 breaths/min
Description

Respiratory rate

Data type

text

Alias
UMLS CUI [1]
C0231832
Pulse > 125/min
Description

Pulse

Data type

text

Alias
UMLS CUI [1]
C0232117
Systolic blood pressure < 90 mmHg
Description

Systolic blood pressure

Data type

text

Alias
UMLS CUI [1]
C0871470
WBC count <5K or >10K
Description

WBC count

Data type

text

Alias
UMLS CUI [1]
C0023508
BUN > 20 mg/dl?
Description

BUN

Data type

text

Alias
UMLS CUI [1]
C0005845
PO2 <60 or Sat <90
Description

PO2, Saturation

Data type

text

Alias
UMLS CUI [1]
C2317096
Was this subject in a health care setting (inpatient) when the pneumonia developed?
Description

Inpatient when pneumonia developed

Data type

text

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0086388
UMLS CUI [1,3]
C0021562
UMLS CUI [1,4]
C0205721
Treatment and Outcome
Description

Treatment and Outcome

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C1547647
Did the subject receive Antibiotics?
Description

Antibiotics

Data type

text

Alias
UMLS CUI [1]
C0003232
What class of antibiotics did the patient initially receive?
Description

Initial Class of antibiotics

Data type

text

Alias
UMLS CUI [1,1]
C0456387
UMLS CUI [1,2]
C0003232
UMLS CUI [1,3]
C0205265
If other class of antibiotics, please specify
Description

Other initial class of antibiotics

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0003232
UMLS CUI [1,4]
C0205265
Was supplementary O2 needed?
Description

Supplementary O2

Data type

text

Alias
UMLS CUI [1]
C4534306
Did the subject require additional treatment beyond antibiotics or was treatment changed?
Description

Additional treatment beyond antibiotics, Treatment changed

Data type

text

Alias
UMLS CUI [1,1]
C1706712
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C0003232
UMLS CUI [2]
C1299575
If yes, select reason additional/different treatment was given
Description

Reason additional treatment

Data type

text

Alias
UMLS CUI [1,1]
C1706712
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C0003232
UMLS CUI [1,4]
C0566251
If there is another reason for additional/different treatment given, please specify
Description

Other reason for additional treatment

Data type

text

Alias
UMLS CUI [1,1]
C1706712
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C0003232
UMLS CUI [1,4]
C3840932
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Similar models

Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome

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
Chest X-ray
C0039985 (UMLS CUI-1)
Item
Was a chest x-rey performed?
text
C0039985 (UMLS CUI [1])
Chest X-ray
Code List
Was a chest x-rey performed?
CL Item
Yes (Y)
CL Item
If No, please comment on why chest x-ray was not obtained (N)
Reason for not obtaining chest x-ray
Item
If No, please comment on why chest x-ray was not obtained
text
C0039985 (UMLS CUI [1,1])
C1882120 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Date of x-ray
Item
Date of x-ray
date
C0039985 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Was an infiltrate present?
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
Infiltrate
Code List
Was an infiltrate present?
CL Item
No (N)
CL Item
If yes, check all lobes involved with infiltrate (Y)
Infiltrate right upper lobe
Item
Infiltrate in right upper lobe
boolean
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261074 (UMLS CUI [1,3])
Infiltrate right middle lobe
Item
Infiltrate in right middle lobe
boolean
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0225757 (UMLS CUI [1,3])
Infiltrate right lower lobe
Item
Infiltrate in right lower lobe
boolean
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261075 (UMLS CUI [1,3])
Infiltrate left upper lobe
Item
Infiltrate in left upper lobe
boolean
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261076 (UMLS CUI [1,3])
Infiltrate lingula
Item
Infiltrate in lingula
boolean
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0225740 (UMLS CUI [1,3])
Infiltrate left lower lobe
Item
Infiltrate left lower lobe
boolean
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261077 (UMLS CUI [1,3])
Item
Characterization of infiltrate
integer
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1880022 (UMLS CUI [1,3])
Characterization of infiltrate
Code List
Characterization of infiltrate
CL Item
Reticular (patchy) (1)
CL Item
Acinar (consolidated) (3)
Item
Was a pleural effusion identified?
integer
C0032227 (UMLS CUI [1])
Pleural effusion
Code List
Was a pleural effusion identified?
CL Item
Absent (0)
CL Item
Present, specify location (1)
Item
If pleural effusion was present, please specify location
integer
C0032227 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Pleural effusion location
Code List
If pleural effusion was present, please specify location
CL Item
Right chest (1)
CL Item
Left chest (2)
CL Item
Bilateral (3)
Item
Was atelectasis present?
text
C0004144 (UMLS CUI [1])
Atelectasis
Code List
Was atelectasis present?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Was a lung mass identified?
text
C0149726 (UMLS CUI [1])
Atelectasis
Code List
Was a lung mass identified?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Was cardiomegaly identified?
text
C0018800 (UMLS CUI [1])
Atelectasis
Code List
Was cardiomegaly identified?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Was pulmonary edema identified?
text
C0034063 (UMLS CUI [1])
Atelectasis
Code List
Was pulmonary edema identified?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Were air bronchograms identified?
text
C3669021 (UMLS CUI [1])
Atelectasis
Code List
Were air bronchograms identified?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Clinical findings from radiology report
Item
Enter clinical findings from a radiology report below:
text
C1299496 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Item Group
Cultures and clinical findings
C0430400 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
Item
Were any culture results obtained?
text
C0430400 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Culture results
Code List
Were any culture results obtained?
CL Item
No (N)
CL Item
Unknown (U)
CL Item
If Yes, provide Date, Pathogen name and Site (Y)
Culture results date
Item
If culture results were obtained, please provide Date
date
C0430400 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Culture result pathogen name
Item
If culture results were obtained, please provide pathogen name
text
C0430400 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0450254 (UMLS CUI [1,3])
Culture result site
Item
If culture result was obtained, please provide Site
text
C0430400 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Item
Temperature <95 F or >= 104 F
text
C0005903 (UMLS CUI [1])
Atelectasis
Code List
Temperature <95 F or >= 104 F
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Did the subject have altered mental status?
text
C0278061 (UMLS CUI [1])
Atelectasis
Code List
Did the subject have altered mental status?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Respiratory rate > 30 breaths/min
text
C0231832 (UMLS CUI [1])
Atelectasis
Code List
Respiratory rate > 30 breaths/min
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Pulse > 125/min
text
C0232117 (UMLS CUI [1])
Atelectasis
Code List
Pulse > 125/min
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Systolic blood pressure < 90 mmHg
text
C0871470 (UMLS CUI [1])
Atelectasis
Code List
Systolic blood pressure < 90 mmHg
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
WBC count <5K or >10K
text
C0023508 (UMLS CUI [1])
Atelectasis
Code List
WBC count <5K or >10K
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
BUN > 20 mg/dl?
text
C0005845 (UMLS CUI [1])
Atelectasis
Code List
BUN > 20 mg/dl?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
PO2 <60 or Sat <90
text
C2317096 (UMLS CUI [1])
Atelectasis
Code List
PO2 <60 or Sat <90
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Was this subject in a health care setting (inpatient) when the pneumonia developed?
text
C0032285 (UMLS CUI [1,1])
C0086388 (UMLS CUI [1,2])
C0021562 (UMLS CUI [1,3])
C0205721 (UMLS CUI [1,4])
Atelectasis
Code List
Was this subject in a health care setting (inpatient) when the pneumonia developed?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item Group
Treatment and Outcome
C0087111 (UMLS CUI-1)
C1547647 (UMLS CUI-2)
Item
Did the subject receive Antibiotics?
text
C0003232 (UMLS CUI [1])
Atelectasis
Code List
Did the subject receive Antibiotics?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
What class of antibiotics did the patient initially receive?
text
C0456387 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
Initial Class of antibiotics
Code List
What class of antibiotics did the patient initially receive?
CL Item
Quinolone (1)
CL Item
Beta-Lactam (2)
CL Item
Macrolide (3)
CL Item
Aminoglykoside (4)
CL Item
Other, specify (Z)
Other initial class of antibiotics
Item
If other class of antibiotics, please specify
text
C0205394 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C0205265 (UMLS CUI [1,4])
Item
Was supplementary O2 needed?
text
C4534306 (UMLS CUI [1])
Atelectasis
Code List
Was supplementary O2 needed?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Did the subject require additional treatment beyond antibiotics or was treatment changed?
text
C1706712 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C1299575 (UMLS CUI [2])
Additional treatment beyond antibiotics, Treatment changed
Code List
Did the subject require additional treatment beyond antibiotics or was treatment changed?
CL Item
No (N)
CL Item
Unknown (U)
CL Item
If yes, reason additional/different treatment given (Y)
Item
If yes, select reason additional/different treatment was given
text
C1706712 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Reason additional treatment
Code List
If yes, select reason additional/different treatment was given
CL Item
Patient failed to improve/Treatment failure (1)
CL Item
Pathogen identified in culture led to change (2)
CL Item
Patient was intolerant of treatment (3)
CL Item
Unknown  (4)
CL Item
Other, specify (Z)
Other reason for additional treatment
Item
If there is another reason for additional/different treatment given, please specify
text
C1706712 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
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