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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

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15 ottobre 2020

DOI

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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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    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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