ID
41565
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 (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
Stichworte
Versionen (3)
- 11.11.20 11.11.20 -
- 11.11.20 11.11.20 -
- 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
Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome
Beschreibung
Chest X-ray
Alias
- UMLS CUI-1
- C0039985
Beschreibung
Chest X-ray
Datentyp
text
Alias
- UMLS CUI [1]
- C0039985
Beschreibung
Reason for not obtaining chest x-ray
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C1882120
- UMLS CUI [1,3]
- C0566251
Beschreibung
Date of x-ray
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0011008
Beschreibung
Infiltrate
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
Beschreibung
Infiltrate right upper lobe
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261074
Beschreibung
Infiltrate right middle lobe
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C0225757
Beschreibung
Infiltrate right lower lobe
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261075
Beschreibung
Infiltrate left upper lobe
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261076
Beschreibung
Infiltrate lingula
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C0225740
Beschreibung
Infiltrate left lower lobe
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261077
Beschreibung
Characterization of infiltrate
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1880022
Beschreibung
Pleural effusion
Datentyp
integer
Alias
- UMLS CUI [1]
- C0032227
Beschreibung
Pleural effusion location
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0032227
- UMLS CUI [1,2]
- C0450429
Beschreibung
Atelectasis
Datentyp
text
Alias
- UMLS CUI [1]
- C0004144
Beschreibung
Lung mass
Datentyp
text
Alias
- UMLS CUI [1]
- C0149726
Beschreibung
Cardiomegaly
Datentyp
text
Alias
- UMLS CUI [1]
- C0018800
Beschreibung
Pulmonary edema
Datentyp
text
Alias
- UMLS CUI [1]
- C0034063
Beschreibung
Air bronchogram
Datentyp
text
Alias
- UMLS CUI [1]
- C3669021
Beschreibung
Clinical findings from radiology report
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299496
- UMLS CUI [1,2]
- C0243095
Beschreibung
Cultures and clinical findings
Alias
- UMLS CUI-1
- C0430400
- UMLS CUI-2
- C0037088
Beschreibung
Culture results
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
Beschreibung
Culture results date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0011008
Beschreibung
Culture result pathogen name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0450254
Beschreibung
Culture result site
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C1515974
Beschreibung
Temperature
Datentyp
text
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Altered mental status
Datentyp
text
Alias
- UMLS CUI [1]
- C0278061
Beschreibung
Respiratory rate
Datentyp
text
Alias
- UMLS CUI [1]
- C0231832
Beschreibung
Pulse
Datentyp
text
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
Systolic blood pressure
Datentyp
text
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
WBC count
Datentyp
text
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
BUN
Datentyp
text
Alias
- UMLS CUI [1]
- C0005845
Beschreibung
PO2, Saturation
Datentyp
text
Alias
- UMLS CUI [1]
- C2317096
Beschreibung
Inpatient when pneumonia developed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0032285
- UMLS CUI [1,2]
- C0086388
- UMLS CUI [1,3]
- C0021562
- UMLS CUI [1,4]
- C0205721
Beschreibung
Treatment and Outcome
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C1547647
Beschreibung
Antibiotics
Datentyp
text
Alias
- UMLS CUI [1]
- C0003232
Beschreibung
Initial Class of antibiotics
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0456387
- UMLS CUI [1,2]
- C0003232
- UMLS CUI [1,3]
- C0205265
Beschreibung
Other initial class of antibiotics
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0456387
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [1,4]
- C0205265
Beschreibung
Supplementary O2
Datentyp
text
Alias
- UMLS CUI [1]
- C4534306
Beschreibung
Additional treatment beyond antibiotics, Treatment changed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1706712
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [2]
- C1299575
Beschreibung
Reason additional treatment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1706712
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [1,4]
- C0566251
Beschreibung
Other reason for additional treatment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1706712
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [1,4]
- C3840932
Ähnliche Modelle
Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome
C2985720 (UMLS CUI [2])
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])
C0235896 (UMLS CUI [1,2])
C1261075 (UMLS CUI [1,3])
C0235896 (UMLS CUI [1,2])
C1261076 (UMLS CUI [1,3])
C0235896 (UMLS CUI [1,2])
C0225740 (UMLS CUI [1,3])
C0235896 (UMLS CUI [1,2])
C1261077 (UMLS CUI [1,3])
C0235896 (UMLS CUI [1,2])
C1880022 (UMLS CUI [1,3])
C0450429 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0037088 (UMLS CUI-2)
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0450254 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0086388 (UMLS CUI [1,2])
C0021562 (UMLS CUI [1,3])
C0205721 (UMLS CUI [1,4])
C0003232 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C0456387 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C0205265 (UMLS CUI [1,4])
C1705847 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C1299575 (UMLS CUI [2])
C1705847 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C1705847 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])