ID

41458

Descrizione

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).

collegamento

https://clinicaltrials.gov/ct2/show/NCT00784550

Keywords

versioni (1)
  1. 15/10/20 15/10/20 -
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GlaxoSmithKline

Caricato su

15 ottobre 2020

DOI

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Licenza

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

Inglese

Eligibility

1 moduli  
  1. StudyEvent: ODM
    1. Eligibility
Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit/assessment
Descrizione

Date of visit/assessment

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Subject identification number
Descrizione

Subject identification number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Eligibility question
Descrizione

Eligibility question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Descrizione

if no, please select all boxes corresponding to violations of any inclusion/exclusion criteria

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Signed and written informed consent from the subject and/or subject’s legally acceptable representative prior to study participation
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
≥40 years of age
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
Male or Female (non-child bearing potential or child bearing potential AND negative pregnancy test AND Abstinence from intercourse, or, Male partner was sterile prior to the female subject’s entry into the study, or, Use of implants of levonorgestrel; or, Injective progesterone; or, Oral contraceptive (combined or progesterone only), contraceptive patch, vaginal ring; or, Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (e.g., Paragard), or, Double barrier technique simultaneously using two of the following: spermicide, male condom, diaphragm, or female condom)
Descrizione

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.

Tipo di dati

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
Diagnosis: An established clinical history of COPD in accordance with the following definitions by the American Thoracic Society (ATS) [Celli, 2004].
Descrizione

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.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0037459
UMLS CUI [1,3]
C0220845
A post-albuterol FEV1 ≥40 to ≤80% of predicted normal and a post-albuterol FEV1/FVC ratio of ≤ 0.70 based on NHANES III reference values [Hankinson, 1999].
Descrizione

post-albuterol FEV1 and post-albuterol FEV1/FVC ratio percent predicted (NHANES III)

Tipo di dati

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
Current or previous smokers with a history of smoking of ≥ 10 pack-years where pack-years are defined as the number of packs of cigarettes smoked per day multiplied by the number of years smoked.
Descrizione

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.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C1277691
UMLS CUI [2,1]
C3241966
UMLS CUI [2,2]
C1277691
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
A current diagnosis of asthma
Descrizione

Asthma

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004096
Any significant disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation, or which would affect the efficacy analysis if the disease/condition exacerbated during the study.
Descrizione

clinically significant disease with risk of safety, or disease exacerbation affecting efficacy analysis

Tipo di dati

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
Has a respiratory disorder other than COPD (e.g., lung cancer, sarcoidosis, active or quiescent tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency)
Descrizione

Respiratory disorder other than COPD (lung cancer, sarcoidosis, tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency)

Tipo di dati

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
Has a known or suspected history of alcohol or drug abuse within the past 2 years
Descrizione

known or suspected recent history of alcohol or drug abuse

Tipo di dati

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
At Visit 1, 12-lead ECG is abnormal and clinically significant. The investigator will determine the clinical significance of the abnormality and determine if a subject is precluded from entering the study.
Descrizione

abnormal and clinically significant 12-lead ECG

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
Chest X-ray (posteroanterior) or computed tomography (CT) scan reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken if the subject has not had one within 6 months of Visit 1.
Descrizione

Chest X-ray or CT clinically significant abnormalities

Tipo di dati

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
Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or corticosteroid (intranasal, inhaled, or systemic including any components of the formulations [e.g. lactose or milk protein]), or atropine or its derivatives, including ipratropium.
Descrizione

Adverse reaction including hypersensitivity to beta2-agonist, sympathomimetic drug, corticosteroid, atropine, atropine derivatives or adverse reaction to drug component

Tipo di dati

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
A BMI of ≥40kg/m2
Descrizione

BMI

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
Use of strong P450 3A4 inhibitors (e.g., Ritonavir)
Descrizione

strong P450 3A4 inhibitors (e.g., Ritonavir)

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2962753
UMLS CUI [1,2]
C0442821
UMLS CUI [2]
C0292818
Taking the following medications before the timeframe prior to Visit 1: LABA/ICS combination products (e.g, ADVAIR, Symbicort), Inhaled corticosteroids, Oral or parenteral corticosteroids, Any investigational drug, Theophylline preparations, Tiotropium, Salmeterol, Formoterol, Oral beta-agonists, Ipratropium, Ipratropium/albuterol combination products (e.g., Combivent), Short-acting beta-agonists (e.g., albuterol)
Descrizione

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

Tipo di dati

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
LTOT is prohibited at any time during the study
Descrizione

Long-Term Oxygen Therapy during study

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0418996
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0347984
Lung resection surgery (e.g., lung volume reduction surgery or lobectomy) within 1 year of Visit 1.
Descrizione

Recent lung surgery

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0038903
UMLS CUI [1,2]
C0332185
Women who are pregnant or lactating at Visit 1
Descrizione

Pregnancy, lactating

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Previously diagnosed cancer unless it is in complete remission for 2 years (no evidence of tumor burden) at Visit 1. Localized carcinomas of the skin that have been resected for cure are not exclusionary.
Descrizione

Cancer (unless in complete remission for 2 years or localized skin cancer)

Tipo di dati

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
Subject is a study Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator or immediate family member of the aforementioned
Descrizione

Affiliation with investigator site

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1510825
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0205145
Any intellectual deficiency including illiteracy, psychiatric illness, or any other condition which will limit the validity of informed consent to participate in the study
Descrizione

Questionable Validity of Consent due to intellectual deficiency (i.e. illiteracy, psychiatric illness)

Tipo di dati

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
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Similar models

Eligibility

1 moduli
  1. StudyEvent: ODM
    1. Eligibility
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Item Group
Eligibility question
C1516637 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
all Entry Criteria met
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed Consent
Item
Signed and written informed consent from the subject and/or subject’s legally acceptable representative prior to study participation
boolean
C0021430 (UMLS CUI [1])
Age
Item
≥40 years of age
boolean
C0001779 (UMLS CUI [1])
Gender, non-child bearing potential, childbearing potential and contraception by female subject or male partner
Item
Male or Female (non-child bearing potential or child bearing potential AND negative pregnancy test AND Abstinence from intercourse, or, Male partner was sterile prior to the female subject’s entry into the study, or, Use of implants of levonorgestrel; or, Injective progesterone; or, Oral contraceptive (combined or progesterone only), contraceptive patch, vaginal ring; or, Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (e.g., Paragard), or, Double barrier technique simultaneously using two of the following: spermicide, male condom, diaphragm, or female condom)
boolean
C0079399 (UMLS CUI [1])
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])
C0086582 (UMLS CUI [4,3])
C0682323 (UMLS CUI [4,4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0086287 (UMLS CUI [5,3])
COPD (ATS)
Item
Diagnosis: An established clinical history of COPD in accordance with the following definitions by the American Thoracic Society (ATS) [Celli, 2004].
boolean
C0024117 (UMLS CUI [1,1])
C0037459 (UMLS CUI [1,2])
C0220845 (UMLS CUI [1,3])
post-albuterol FEV1 and post-albuterol FEV1/FVC ratio percent predicted (NHANES III)
Item
A post-albuterol FEV1 ≥40 to ≤80% of predicted normal and a post-albuterol FEV1/FVC ratio of ≤ 0.70 based on NHANES III reference values [Hankinson, 1999].
boolean
C0001927 (UMLS CUI [1,1])
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])
Current or former Smoker (pack-years)
Item
Current or previous smokers with a history of smoking of ≥ 10 pack-years where pack-years are defined as the number of packs of cigarettes smoked per day multiplied by the number of years smoked.
boolean
C0337671 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
C3241966 (UMLS CUI [2,1])
C1277691 (UMLS CUI [2,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Asthma
Item
A current diagnosis of asthma
boolean
C0004096 (UMLS CUI [1])
clinically significant disease with risk of safety, or disease exacerbation affecting efficacy analysis
Item
Any significant disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation, or which would affect the efficacy analysis if the disease/condition exacerbated during the study.
boolean
C2826293 (UMLS CUI [1,1])
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])
Respiratory disorder other than COPD (lung cancer, sarcoidosis, tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency)
Item
Has a respiratory disorder other than COPD (e.g., lung cancer, sarcoidosis, active or quiescent tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency)
boolean
C0035204 (UMLS CUI [1,1])
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])
known or suspected recent history of alcohol or drug abuse
Item
Has a known or suspected history of alcohol or drug abuse within the past 2 years
boolean
C0038586 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
abnormal and clinically significant 12-lead ECG
Item
At Visit 1, 12-lead ECG is abnormal and clinically significant. The investigator will determine the clinical significance of the abnormality and determine if a subject is precluded from entering the study.
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Chest X-ray or CT clinically significant abnormalities
Item
Chest X-ray (posteroanterior) or computed tomography (CT) scan reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken if the subject has not had one within 6 months of Visit 1.
boolean
C2985739 (UMLS CUI [1,1])
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])
Adverse reaction including hypersensitivity to beta2-agonist, sympathomimetic drug, corticosteroid, atropine, atropine derivatives or adverse reaction to drug component
Item
Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or corticosteroid (intranasal, inhaled, or systemic including any components of the formulations [e.g. lactose or milk protein]), or atropine or its derivatives, including ipratropium.
boolean
C0559546 (UMLS CUI [1,1])
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])
BMI
Item
A BMI of ≥40kg/m2
boolean
C1305855 (UMLS CUI [1])
strong P450 3A4 inhibitors (e.g., Ritonavir)
Item
Use of strong P450 3A4 inhibitors (e.g., Ritonavir)
boolean
C2962753 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C0292818 (UMLS CUI [2])
Prior Medication: LABA/ICS combination products (e.g, ADVAIR, Symbicort), Inhaled corticosteroids, Oral or parenteral corticosteroids, Any investigational drug, Theophylline preparations, Tiotropium, Salmeterol, Formoterol, Oral beta-agonists, Ipratropium, Ipratropium/albuterol combination products (e.g., Combivent), Short-acting beta-agonists (e.g., albuterol)
Item
Taking the following medications before the timeframe prior to Visit 1: LABA/ICS combination products (e.g, ADVAIR, Symbicort), Inhaled corticosteroids, Oral or parenteral corticosteroids, Any investigational drug, Theophylline preparations, Tiotropium, Salmeterol, Formoterol, Oral beta-agonists, Ipratropium, Ipratropium/albuterol combination products (e.g., Combivent), Short-acting beta-agonists (e.g., albuterol)
boolean
C2065041 (UMLS CUI [1,1])
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])
Long-Term Oxygen Therapy during study
Item
LTOT is prohibited at any time during the study
boolean
C0418996 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Recent lung surgery
Item
Lung resection surgery (e.g., lung volume reduction surgery or lobectomy) within 1 year of Visit 1.
boolean
C0038903 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Pregnancy, lactating
Item
Women who are pregnant or lactating at Visit 1
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer (unless in complete remission for 2 years or localized skin cancer)
Item
Previously diagnosed cancer unless it is in complete remission for 2 years (no evidence of tumor burden) at Visit 1. Localized carcinomas of the skin that have been resected for cure are not exclusionary.
boolean
C0006826 (UMLS CUI [1])
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])
Affiliation with investigator site
Item
Subject is a study Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator or immediate family member of the aforementioned
boolean
C1510825 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,3])
Questionable Validity of Consent due to intellectual deficiency (i.e. illiteracy, psychiatric illness)
Item
Any intellectual deficiency including illiteracy, psychiatric illness, or any other condition which will limit the validity of informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1,1])
C2349101 (UMLS CUI [1,2])
C0332241 (UMLS CUI [1,3])
C3714756 (UMLS CUI [1,4])
C0020899 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
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