ID
41570
Descripción
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
Palabras clave
Versiones (3)
- 11/11/20 11/11/20 -
- 11/11/20 11/11/20 -
- 11/11/20 11/11/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
11 de noviembre de 2020
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Chest X-ray
Alias
- UMLS CUI-1
- C0039985
Descripción
Chest X-ray
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0039985
Descripción
Reason for not obtaining chest x-ray
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C1882120
- UMLS CUI [1,3]
- C0566251
Descripción
Date of x-ray
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0011008
Descripción
Infiltrate
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
Descripción
Infiltrate right upper lobe
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261074
Descripción
Infiltrate right middle lobe
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C0225757
Descripción
Infiltrate right lower lobe
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261075
Descripción
Infiltrate left upper lobe
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261076
Descripción
Infiltrate lingula
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C0225740
Descripción
Infiltrate left lower lobe
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261077
Descripción
Characterization of infiltrate
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1880022
Descripción
Pleural effusion
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0032227
Descripción
Pleural effusion location
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0032227
- UMLS CUI [1,2]
- C0450429
Descripción
Atelectasis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0004144
Descripción
Lung mass
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0149726
Descripción
Cardiomegaly
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0018800
Descripción
Pulmonary edema
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0034063
Descripción
Air bronchogram
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3669021
Descripción
Clinical findings from radiology report
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1299496
- UMLS CUI [1,2]
- C0243095
Descripción
Cultures and clinical findings
Alias
- UMLS CUI-1
- C0430400
- UMLS CUI-2
- C0037088
Descripción
Culture results
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
Descripción
Culture results date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0011008
Descripción
Culture result pathogen name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0450254
Descripción
Culture result site
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C1515974
Descripción
Temperature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0005903
Descripción
Altered mental status
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0278061
Descripción
Respiratory rate
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0231832
Descripción
Pulse
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0232117
Descripción
Systolic blood pressure
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0871470
Descripción
WBC count
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0023508
Descripción
BUN
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0005845
Descripción
PO2, Saturation
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2317096
Descripción
Inpatient when pneumonia developed
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0032285
- UMLS CUI [1,2]
- C0086388
- UMLS CUI [1,3]
- C0021562
- UMLS CUI [1,4]
- C0205721
Descripción
Treatment and Outcome
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C1547647
Descripción
Antibiotics
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0003232
Descripción
Initial Class of antibiotics
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0456387
- UMLS CUI [1,2]
- C0003232
- UMLS CUI [1,3]
- C0205265
Descripción
Other initial class of antibiotics
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0456387
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [1,4]
- C0205265
Descripción
Supplementary O2
Tipo de datos
text
Alias
- UMLS CUI [1]
- C4534306
Descripción
Additional treatment beyond antibiotics, Treatment changed
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1706712
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [2]
- C1299575
Descripción
Reason additional treatment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1706712
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [1,4]
- C0566251
Descripción
Other reason for additional treatment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1706712
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [1,4]
- C3840932
Similar models
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])