ID
41560
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)
- 11/11/20 11/11/20 -
- 11/11/20 11/11/20 -
- 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
Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome
Description
Chest X-ray
Alias
- UMLS CUI-1
- C0039985
Description
Chest X-ray
Data type
text
Alias
- UMLS CUI [1]
- C0039985
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
Description
Date of x-ray
Data type
date
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0011008
Description
Infiltrate
Data type
text
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
Description
Infiltrate right upper lobe
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261074
Description
Infiltrate right middle lobe
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C0225757
Description
Infiltrate right lower lobe
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261075
Description
Infiltrate left upper lobe
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261076
Description
Infiltrate lingula
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C0225740
Description
Infiltrate left lower lobe
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261077
Description
Characterization of infiltrate
Data type
integer
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1880022
Description
Pleural effusion
Data type
integer
Alias
- UMLS CUI [1]
- C0032227
Description
Pleural effusion location
Data type
integer
Alias
- UMLS CUI [1,1]
- C0032227
- UMLS CUI [1,2]
- C0450429
Description
Atelectasis
Data type
text
Alias
- UMLS CUI [1]
- C0004144
Description
Lung mass
Data type
text
Alias
- UMLS CUI [1]
- C0149726
Description
Cardiomegaly
Data type
text
Alias
- UMLS CUI [1]
- C0018800
Description
Pulmonary edema
Data type
text
Alias
- UMLS CUI [1]
- C0034063
Description
Air bronchogram
Data type
text
Alias
- UMLS CUI [1]
- C3669021
Description
Clinical findings from radiology report
Data type
text
Alias
- UMLS CUI [1,1]
- C1299496
- UMLS CUI [1,2]
- C0243095
Description
Cultures and clinical findings
Alias
- UMLS CUI-1
- C0430400
- UMLS CUI-2
- C0037088
Description
Culture results
Data type
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
Description
Culture results date
Data type
date
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0011008
Description
Culture result pathogen name
Data type
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0450254
Description
Culture result site
Data type
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C1515974
Description
Temperature
Data type
text
Alias
- UMLS CUI [1]
- C0005903
Description
Altered mental status
Data type
text
Alias
- UMLS CUI [1]
- C0278061
Description
Respiratory rate
Data type
text
Alias
- UMLS CUI [1]
- C0231832
Description
Pulse
Data type
text
Alias
- UMLS CUI [1]
- C0232117
Description
Systolic blood pressure
Data type
text
Alias
- UMLS CUI [1]
- C0871470
Description
WBC count
Data type
text
Alias
- UMLS CUI [1]
- C0023508
Description
BUN
Data type
text
Alias
- UMLS CUI [1]
- C0005845
Description
PO2, Saturation
Data type
text
Alias
- UMLS CUI [1]
- C2317096
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
Description
Treatment and Outcome
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C1547647
Description
Antibiotics
Data type
text
Alias
- UMLS CUI [1]
- C0003232
Description
Initial Class of antibiotics
Data type
text
Alias
- UMLS CUI [1,1]
- C0456387
- UMLS CUI [1,2]
- C0003232
- UMLS CUI [1,3]
- C0205265
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
Description
Supplementary O2
Data type
text
Alias
- UMLS CUI [1]
- C4534306
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
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
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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Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome
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C1882120 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0235896 (UMLS CUI [1,2])
C1261074 (UMLS CUI [1,3])
C0235896 (UMLS CUI [1,2])
C0225757 (UMLS CUI [1,3])
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C0037088 (UMLS CUI-2)
C1274040 (UMLS CUI [1,2])
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C0011008 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
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C1274040 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
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