Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 40 Years
Item
age at least 40 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
All patients must sign an informed consent
Item
All patients must sign an informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Diagnosis of COPD with specific spirometric criteria (determined at study visits)
Item
Diagnosis of COPD with specific spirometric criteria (determined at study visits)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0024117 (UMLS CUI 2011AA)
13645005 (SNOMED CT 2011_0131)
10009033 (MedDRA 14.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
C1552740 (UMLS CUI 2011AA)
C0037981 (UMLS CUI 2011AA)
127783003 (SNOMED CT 2011_0131)
10041629 (MedDRA 14.1)
CL414621 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Age >= 40 years
Item
Age >= 40 years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Medical Research Council Dyspnoea score >= 2
Item
Medical Research Council Dyspnea Scale >= 2
boolean
C1513061 (UMLS CUI 2011AA)
Current or ex-smoker with a >= 10 pack-year smoking history
Item
Current or ex-smoker with a >= 10 pack-year smoking history
boolean
C0337664 (UMLS CUI 2011AA)
77176002 (SNOMED CT 2011_0131)
10048880 (MedDRA 14.1)
C0337671 (UMLS CUI 2011AA)
8517006 (SNOMED CT 2011_0131)
10015572 (MedDRA 14.1)
C1277691 (UMLS CUI 2011AA)
315609007 (SNOMED CT 2011_0131)
C1519384 (UMLS CUI 2011AA)
Ability to exercise on treadmill
Item
Ability to exercise on treadmill
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0184069 (UMLS CUI 2011AA)
1211003 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
Item
Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0024117 (UMLS CUI 2011AA)
13645005 (SNOMED CT 2011_0131)
10009033 (MedDRA 14.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1610642 (UMLS CUI 2011AA)
440181000 (SNOMED CT 2011_0131)
C0600260 (UMLS CUI 2011AA)
10025081 (MedDRA 14.1)
C0039991 (UMLS CUI 2011AA)
177765008 (SNOMED CT 2011_0131)
10043491 (MedDRA 14.1)
34.01 (ICD-9-CM Version 2011)
C0396565 (UMLS CUI 2011AA)
119746007 (SNOMED CT 2011_0131)
C1869044 (UMLS CUI 2011AA)
20000042 (MedDRA 14.1)
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C0040038 (UMLS CUI 2011AA)
371039008 (SNOMED CT 2011_0131)
10043566 (MedDRA 14.1)
453.9 (ICD-9-CM Version 2011)
E13825 (CTCAE 1105E)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0006267 (UMLS CUI 2011AA)
12295008 (SNOMED CT 2011_0131)
10006445 (MedDRA 14.1)
J47.9 (ICD-10-CM Version 2010)
494 (ICD-9-CM Version 2011)
C0151332 (UMLS CUI 2011AA)
427099000 (SNOMED CT 2011_0131)
10071157 (MedDRA 14.1)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C1881878 (UMLS CUI 2011AA)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0341697 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
Clinical history of asthma
Item
Clinical history of asthma
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
Use of supplemental oxygen therapy
Item
Use of supplemental oxygen therapy
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C2348609 (UMLS CUI 2011AA)
CL426373 (UMLS CUI 2011AA)
Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
Item
Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
boolean
C0035243 (UMLS CUI 2011AA)
275498002 (SNOMED CT 2011_0131)
10062352 (MedDRA 14.1)
MTHU026191 (LOINC Version 232)
C0740304 (UMLS CUI 2011AA)
10010953 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1710661 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
C0034656 (UMLS CUI 2011AA)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C2004454 (UMLS CUI 2011AA)
Recent history (<= 12 months) of myocardial infarction
Item
Recent history (<= 12 months) of myocardial infarction
boolean
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Unstable or life-threatening cardiac arrhythmia
Item
Unstable or life-threatening cardiac arrhythmia
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C1610642 (UMLS CUI 2011AA)
440181000 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
Malignancy treated with radiation therapy or chemotherapy in the last 5 years
Item
Malignancy treated with radiation therapy or chemotherapy in the last 5 years
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0332293 (UMLS CUI 2011AA)
28995006 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Pregnant or nursing women
Item
Pregnant or nursing women
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Known hypersensitivity to anticholinergic drugs or any component of the study medications
Item
Known hypersensitivity to anticholinergic drugs or any component of the study medications
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0570982 (UMLS CUI 2011AA)
294065003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0552536 (UMLS CUI 2011AA)
MTHU002637 (LOINC Version 232)
Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
Item
Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C1522601 (UMLS CUI 2011AA)
C0034991 (UMLS CUI 2011AA)
52052004 (SNOMED CT 2011_0131)
10057374 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Estimated life expectancy < 2 years
Item
Estimated life expectancy < 2 years
boolean
C0023671 (UMLS CUI 2011AA)
414135002 (SNOMED CT 2011_0131)
Symptomatic prostatic hyperplasia or bladder neck obstruction
Item
Symptomatic prostatic hyperplasia or bladder neck obstruction
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C2937421 (UMLS CUI 2011AA)
433234005 (SNOMED CT 2011_0131)
10020728 (MedDRA 14.1)
N40 (ICD-10-CM Version 2010)
600 (ICD-9-CM Version 2011)
C0005694 (UMLS CUI 2011AA)
399072004 (SNOMED CT 2011_0131)
10005060 (MedDRA 14.1)
N32.0 (ICD-10-CM Version 2010)
596.0 (ICD-9-CM Version 2011)
Known narrow-angle glaucoma
Item
Known narrow-angle glaucoma
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0017605 (UMLS CUI 2011AA)
392291006 (SNOMED CT 2011_0131)
10002500 (MedDRA 14.1)
Any condition that is contraindicated for exercise
Item
Any condition that is contraindicated for exercise
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
Item
Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
boolean
C0026857 (UMLS CUI 2011AA)
928000 (SNOMED CT 2011_0131)
10048592 (MedDRA 14.1)
C0026848 (UMLS CUI 2011AA)
129565002 (SNOMED CT 2011_0131)
10028641 (MedDRA 14.1)
G72.9 (ICD-10-CM Version 2010)
359.9 (ICD-9-CM Version 2011)
C0442874 (UMLS CUI 2011AA)
386033004 (SNOMED CT 2011_0131)
10029328 (MedDRA 14.1)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0205272 (UMLS CUI 2011AA)
17854005 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0001701 (UMLS CUI 2011AA)
229072005 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0039593 (UMLS CUI 2011AA)
Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space
Item
Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
C0745732 (UMLS CUI 2011AA)
CL381565 (UMLS CUI 2011AA)
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