ID
41570
Beschrijving
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
Trefwoorden
Versies (3)
- 11-11-20 11-11-20 -
- 11-11-20 11-11-20 -
- 11-11-20 11-11-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
11 november 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
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
Beschrijving
Chest X-ray
Alias
- UMLS CUI-1
- C0039985
Beschrijving
Chest X-ray
Datatype
text
Alias
- UMLS CUI [1]
- C0039985
Beschrijving
Reason for not obtaining chest x-ray
Datatype
text
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C1882120
- UMLS CUI [1,3]
- C0566251
Beschrijving
Date of x-ray
Datatype
date
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0011008
Beschrijving
Infiltrate
Datatype
text
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
Beschrijving
Infiltrate right upper lobe
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261074
Beschrijving
Infiltrate right middle lobe
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C0225757
Beschrijving
Infiltrate right lower lobe
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261075
Beschrijving
Infiltrate left upper lobe
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261076
Beschrijving
Infiltrate lingula
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C0225740
Beschrijving
Infiltrate left lower lobe
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1261077
Beschrijving
Characterization of infiltrate
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0235896
- UMLS CUI [1,3]
- C1880022
Beschrijving
Pleural effusion
Datatype
integer
Alias
- UMLS CUI [1]
- C0032227
Beschrijving
Pleural effusion location
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0032227
- UMLS CUI [1,2]
- C0450429
Beschrijving
Atelectasis
Datatype
text
Alias
- UMLS CUI [1]
- C0004144
Beschrijving
Lung mass
Datatype
text
Alias
- UMLS CUI [1]
- C0149726
Beschrijving
Cardiomegaly
Datatype
text
Alias
- UMLS CUI [1]
- C0018800
Beschrijving
Pulmonary edema
Datatype
text
Alias
- UMLS CUI [1]
- C0034063
Beschrijving
Air bronchogram
Datatype
text
Alias
- UMLS CUI [1]
- C3669021
Beschrijving
Clinical findings from radiology report
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299496
- UMLS CUI [1,2]
- C0243095
Beschrijving
Cultures and clinical findings
Alias
- UMLS CUI-1
- C0430400
- UMLS CUI-2
- C0037088
Beschrijving
Culture results
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
Beschrijving
Culture results date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0011008
Beschrijving
Culture result pathogen name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0450254
Beschrijving
Culture result site
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C1515974
Beschrijving
Temperature
Datatype
text
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Altered mental status
Datatype
text
Alias
- UMLS CUI [1]
- C0278061
Beschrijving
Respiratory rate
Datatype
text
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Pulse
Datatype
text
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Systolic blood pressure
Datatype
text
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
WBC count
Datatype
text
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
BUN
Datatype
text
Alias
- UMLS CUI [1]
- C0005845
Beschrijving
PO2, Saturation
Datatype
text
Alias
- UMLS CUI [1]
- C2317096
Beschrijving
Inpatient when pneumonia developed
Datatype
text
Alias
- UMLS CUI [1,1]
- C0032285
- UMLS CUI [1,2]
- C0086388
- UMLS CUI [1,3]
- C0021562
- UMLS CUI [1,4]
- C0205721
Beschrijving
Treatment and Outcome
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C1547647
Beschrijving
Antibiotics
Datatype
text
Alias
- UMLS CUI [1]
- C0003232
Beschrijving
Initial Class of antibiotics
Datatype
text
Alias
- UMLS CUI [1,1]
- C0456387
- UMLS CUI [1,2]
- C0003232
- UMLS CUI [1,3]
- C0205265
Beschrijving
Other initial class of antibiotics
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0456387
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [1,4]
- C0205265
Beschrijving
Supplementary O2
Datatype
text
Alias
- UMLS CUI [1]
- C4534306
Beschrijving
Additional treatment beyond antibiotics, Treatment changed
Datatype
text
Alias
- UMLS CUI [1,1]
- C1706712
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [2]
- C1299575
Beschrijving
Reason additional treatment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1706712
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0003232
- UMLS CUI [1,4]
- C0566251
Beschrijving
Other reason for additional treatment
Datatype
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])