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])
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])