ID
41458
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 (Eligibility) is to be filled out at the Screening (Visit 1).
Link
https://clinicaltrials.gov/ct2/show/NCT00784550
Keywords
Versions (1)
- 10/15/20 10/15/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 15, 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
Eligibility
- StudyEvent: ODM
Description
Eligibility question
Alias
- UMLS CUI-1
- C1516637
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Informed Consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Female subjects, with the exception of post-menopausal females and surgically sterile females, will undergo a urine pregnancy test at every study visit and the Premature Discontinuation Visit if applicable. Any female who becomes pregnant during the study will be withdrawn. Female subjects should not be enrolled if they plan to become pregnant during the time of study participation.
Data type
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2,1]
- C3831118
- UMLS CUI [2,2]
- C0332197
- UMLS CUI [3,1]
- C3831118
- UMLS CUI [3,2]
- C0427780
- UMLS CUI [4,1]
- C3831118
- UMLS CUI [4,2]
- C0700589
- UMLS CUI [4,3]
- C0086582
- UMLS CUI [4,4]
- C0682323
- UMLS CUI [5,1]
- C3831118
- UMLS CUI [5,2]
- C0700589
- UMLS CUI [5,3]
- C0086287
Description
COPD is a preventable and treatable disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive defined as a disease state characterized by the presence of airflow obstruction and an abnormal inflammatory response of the lungs to noxious particles or gasses, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C0037459
- UMLS CUI [1,3]
- C0220845
Description
post-albuterol FEV1 and post-albuterol FEV1/FVC ratio percent predicted (NHANES III)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0001927
- UMLS CUI [1,2]
- C0730561
- UMLS CUI [1,3]
- C2825743
- UMLS CUI [2,1]
- C0001927
- UMLS CUI [2,2]
- C3828600
- UMLS CUI [2,3]
- C2825743
Description
pack-years are defined as the number of packs of cigarettes smoked per day multiplied by the number of years smoked. All current smokers considered for the study may be counselled at the investigator’s discretion regarding hazards of continuing to smoke and the benefits of cessation. Ex-smokers are defined as subjects who have discontinued smoking for ≥ 6 months prior to Visit 1.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0337671
- UMLS CUI [1,2]
- C1277691
- UMLS CUI [2,1]
- C3241966
- UMLS CUI [2,2]
- C1277691
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Asthma
Data type
boolean
Alias
- UMLS CUI [1]
- C0004096
Description
clinically significant disease with risk of safety, or disease exacerbation affecting efficacy analysis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2826293
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C1444641
- UMLS CUI [1,4]
- C1113679
- UMLS CUI [1,5]
- C0022423
- UMLS CUI [1,6]
- C0008961
- UMLS CUI [2,1]
- C0235874
- UMLS CUI [2,2]
- C0392760
- UMLS CUI [2,3]
- C1280519
- UMLS CUI [2,4]
- C0936012
- UMLS CUI [2,5]
- C0022423
- UMLS CUI [2,6]
- C0008961
Description
Respiratory disorder other than COPD (lung cancer, sarcoidosis, tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035204
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0024117
- UMLS CUI [2]
- C0242379
- UMLS CUI [3]
- C0036202
- UMLS CUI [4]
- C0041327
- UMLS CUI [5]
- C0006267
- UMLS CUI [6]
- C0034069
- UMLS CUI [7]
- C0010674
- UMLS CUI [8]
- C0221757
Description
known or suspected recent history of alcohol or drug abuse
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0038586
- UMLS CUI [2,2]
- C0332185
- UMLS CUI [2,3]
- C0750491
Description
abnormal and clinically significant 12-lead ECG
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
Description
Chest X-ray or CT clinically significant abnormalities
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2985739
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0039985
- UMLS CUI [1,4]
- C1705847
- UMLS CUI [1,5]
- C0024117
- UMLS CUI [2,1]
- C2985739
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [2,3]
- C0040405
- UMLS CUI [2,4]
- C1705847
- UMLS CUI [2,5]
- C0024117
Description
Adverse reaction including hypersensitivity to beta2-agonist, sympathomimetic drug, corticosteroid, atropine, atropine derivatives or adverse reaction to drug component
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1373132
- UMLS CUI [2,1]
- C0559546
- UMLS CUI [2,2]
- C0039052
- UMLS CUI [3,1]
- C0559546
- UMLS CUI [3,2]
- C0001617
- UMLS CUI [4,1]
- C0559546
- UMLS CUI [4,2]
- C0004259
- UMLS CUI [5,1]
- C0559546
- UMLS CUI [5,2]
- C0004260
- UMLS CUI [6,1]
- C0020517
- UMLS CUI [6,2]
- C1373132
- UMLS CUI [7,1]
- C0020517
- UMLS CUI [7,2]
- C0039052
- UMLS CUI [8,1]
- C0020517
- UMLS CUI [8,2]
- C0001617
- UMLS CUI [9,1]
- C0559546
- UMLS CUI [9,2]
- C0013227
- UMLS CUI [9,3]
- C1705248
- UMLS CUI [10,1]
- C0020517
- UMLS CUI [10,2]
- C0004259
- UMLS CUI [11,1]
- C0020517
- UMLS CUI [11,2]
- C0004260
Description
BMI
Data type
boolean
Alias
- UMLS CUI [1]
- C1305855
Description
strong P450 3A4 inhibitors (e.g., Ritonavir)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2962753
- UMLS CUI [1,2]
- C0442821
- UMLS CUI [2]
- C0292818
Description
Washout period prior to Visit 1 LABA/ICS combination products (e.g, ADVAIR, Symbicort): 30 days Inhaled corticosteroids: 30 days Oral or parenteral corticosteroids: 30 days Any investigational drug: 30 days Theophylline preparations: 48 hours Tiotropium: 48 hours Salmeterol: 24 hours Formoterol: 24 hours Oral beta-agonists: 12 hours Ipratropium: 6 hours Ipratropium/albuterol combination products (e.g., Combivent): 6 hours Short-acting beta-agonists (e.g., albuterol): 6 hours
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2065041
- UMLS CUI [1,2]
- C0001644
- UMLS CUI [1,3]
- C0205195
- UMLS CUI [2]
- C2065041
- UMLS CUI [3]
- C4053960
- UMLS CUI [4]
- C0013230
- UMLS CUI [5,1]
- C0039771
- UMLS CUI [5,2]
- C0332185
- UMLS CUI [6,1]
- C0213771
- UMLS CUI [6,2]
- C0332185
- UMLS CUI [7,1]
- C0073992
- UMLS CUI [7,2]
- C0332185
- UMLS CUI [8,1]
- C0060657
- UMLS CUI [8,2]
- C0332185
- UMLS CUI [9,1]
- C0001644
- UMLS CUI [9,2]
- C0442027
- UMLS CUI [9,3]
- C0332185
- UMLS CUI [10,1]
- C0700580
- UMLS CUI [10,2]
- C0332185
- UMLS CUI [11,1]
- C0700580
- UMLS CUI [11,2]
- C0001927
- UMLS CUI [11,3]
- C0205195
- UMLS CUI [11,4]
- C0332185
- UMLS CUI [12,1]
- C0001644
- UMLS CUI [12,2]
- C0332185
Description
Long-Term Oxygen Therapy during study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0418996
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Description
Recent lung surgery
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038903
- UMLS CUI [1,2]
- C0332185
Description
Pregnancy, lactating
Data type
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Description
Cancer (unless in complete remission for 2 years or localized skin cancer)
Data type
boolean
Alias
- UMLS CUI [1]
- C0006826
- UMLS CUI [2,1]
- C0006826
- UMLS CUI [2,2]
- C0332300
- UMLS CUI [2,3]
- C0677874
- UMLS CUI [2,4]
- C3843647
- UMLS CUI [3,1]
- C0006826
- UMLS CUI [3,2]
- C1705847
- UMLS CUI [3,3]
- C0699893
- UMLS CUI [3,4]
- C0392752
Description
Affiliation with investigator site
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1510825
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0205145
Description
Questionable Validity of Consent due to intellectual deficiency (i.e. illiteracy, psychiatric illness)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2349101
- UMLS CUI [1,3]
- C0332241
- UMLS CUI [1,4]
- C3714756
- UMLS CUI [2]
- C0020899
- UMLS CUI [3]
- C0004936
Similar models
Eligibility
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C1550543 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
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C0682323 (UMLS CUI [4,4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0086287 (UMLS CUI [5,3])
C0037459 (UMLS CUI [1,2])
C0220845 (UMLS CUI [1,3])
C0730561 (UMLS CUI [1,2])
C2825743 (UMLS CUI [1,3])
C0001927 (UMLS CUI [2,1])
C3828600 (UMLS CUI [2,2])
C2825743 (UMLS CUI [2,3])
C1277691 (UMLS CUI [1,2])
C3241966 (UMLS CUI [2,1])
C1277691 (UMLS CUI [2,2])
C0012634 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0022423 (UMLS CUI [1,5])
C0008961 (UMLS CUI [1,6])
C0235874 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1280519 (UMLS CUI [2,3])
C0936012 (UMLS CUI [2,4])
C0022423 (UMLS CUI [2,5])
C0008961 (UMLS CUI [2,6])
C1705847 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C0242379 (UMLS CUI [2])
C0036202 (UMLS CUI [3])
C0041327 (UMLS CUI [4])
C0006267 (UMLS CUI [5])
C0034069 (UMLS CUI [6])
C0010674 (UMLS CUI [7])
C0221757 (UMLS CUI [8])
C0332185 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0039985 (UMLS CUI [1,3])
C1705847 (UMLS CUI [1,4])
C0024117 (UMLS CUI [1,5])
C2985739 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C1705847 (UMLS CUI [2,4])
C0024117 (UMLS CUI [2,5])
C1373132 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0039052 (UMLS CUI [2,2])
C0559546 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C0559546 (UMLS CUI [4,1])
C0004259 (UMLS CUI [4,2])
C0559546 (UMLS CUI [5,1])
C0004260 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C1373132 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0039052 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0001617 (UMLS CUI [8,2])
C0559546 (UMLS CUI [9,1])
C0013227 (UMLS CUI [9,2])
C1705248 (UMLS CUI [9,3])
C0020517 (UMLS CUI [10,1])
C0004259 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0004260 (UMLS CUI [11,2])
C0442821 (UMLS CUI [1,2])
C0292818 (UMLS CUI [2])
C0001644 (UMLS CUI [1,2])
C0205195 (UMLS CUI [1,3])
C2065041 (UMLS CUI [2])
C4053960 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
C0039771 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
C0213771 (UMLS CUI [6,1])
C0332185 (UMLS CUI [6,2])
C0073992 (UMLS CUI [7,1])
C0332185 (UMLS CUI [7,2])
C0060657 (UMLS CUI [8,1])
C0332185 (UMLS CUI [8,2])
C0001644 (UMLS CUI [9,1])
C0442027 (UMLS CUI [9,2])
C0332185 (UMLS CUI [9,3])
C0700580 (UMLS CUI [10,1])
C0332185 (UMLS CUI [10,2])
C0700580 (UMLS CUI [11,1])
C0001927 (UMLS CUI [11,2])
C0205195 (UMLS CUI [11,3])
C0332185 (UMLS CUI [11,4])
C0001644 (UMLS CUI [12,1])
C0332185 (UMLS CUI [12,2])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0006826 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0677874 (UMLS CUI [2,3])
C3843647 (UMLS CUI [2,4])
C0006826 (UMLS CUI [3,1])
C1705847 (UMLS CUI [3,2])
C0699893 (UMLS CUI [3,3])
C0392752 (UMLS CUI [3,4])
C0008961 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,3])
C2349101 (UMLS CUI [1,2])
C0332241 (UMLS CUI [1,3])
C3714756 (UMLS CUI [1,4])
C0020899 (UMLS CUI [2])
C0004936 (UMLS CUI [3])