ID

14309

Description

Study to Compare the Effects of Z7200 And Symbicort® Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02227394

Link

https://clinicaltrials.gov/show/NCT02227394

Keywords

Versions (1)
  1. 4/9/16 4/9/16 -
Uploaded on

April 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT02227394

English

Eligibility Asthma NCT02227394

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02227394
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patient ≥ 18 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. written informed consent obtained.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
3. patient with a documented diagnosis of asthma according to the global initiative for asthma (gina) guidelines
Description

Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
4. patient with a co-operative attitude and ability to correctly use the dpi.
Description

Compliance behavior | Use of Dry Powder Inhaler (device)

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C1967611
5. female patient of childbearing potential who confirm that a reliable method of contraception was used at least 14 days before visit 1 and will continue to use a reliable method of contraception during the study, or post-menopausal women (at least 12 months of amenorrhea)
Description

Childbearing Potential Contraceptive methods | Postmenopausal state | Amenorrhea

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0002453
6. patient must be stable and treated in accordance with the gina guidelines.
Description

Stable status | Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0205360
UMLS CUI [2]
C0087111
7. patient must be a non-smoker or ex-smoker who have stopped smoking at least 1 month prior to visit 1 and has a smoking history of < 10 pack years.
Description

Non-smoker | Former smoker Stopped smoking smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0337671
UMLS CUI [2,2]
C0425310
UMLS CUI [2,3]
C2230126
8. patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating female.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. unstable patient who developed an asthma exacerbation in the 4 weeks before screening.
Description

Exacerbation of asthma | Unstable status

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0443343
3. patient with upper or lower airways infection in the 4 weeks before screening.
Description

Upper Respiratory Infections | Lower respiratory tract infection

Data type

boolean

Alias
UMLS CUI [1]
C0041912
UMLS CUI [2]
C0149725
4. patient unable to perform pulmonary function testing.
Description

Unable Pulmonary function tests

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0024119
5. patients unable to withdraw fixed combination or long acting bronchodilator inhalation products
Description

Inhaled bronchodilator therapy | Unable Withdraw

Data type

boolean

Alias
UMLS CUI [1]
C0578554
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C2349954
6. patient with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
Description

Disease Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
7. patient with active lung cancer or any other chronic disease with poor prognosis and
Description

Malignant neoplasm of lung | Chronic disease Prognosis bad

Data type

boolean

Alias
UMLS CUI [1]
C0242379
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0278252
/or affecting patient status.
Description

Chronic disease Affecting Patient status

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0449437
8. patient with allergy, sensitivity or intolerance to study drugs and/ or study drug formulation ingredients.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Formulation Ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705957
UMLS CUI [2,3]
C1550600
9. patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
Description

Compliance behavior | Patient Non-Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0376405
10. patient who received systemic corticosteroids within the last 4 weeks prior to visit
Description

systemic steroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
11. patient who received any investigational new drug within the last 4 weeks prior to visit 1 and is participating in any clinical trial.
Description

Investigational New Drugs | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
12. patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
13. patient with diagnosis of chronic obstructive pulmonary disease (copd).
Description

Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1]
C0024117
14. patients who has a lactose intolerance or history of allergy to milk proteins.
Description

Lactose Intolerance | Milk protein allergy

Data type

boolean

Alias
UMLS CUI [1]
C0022951
UMLS CUI [2]
C3889086
15. patients treated with medications or herbal medicines that are strong cytochrome p450 3a4 (cyp3a4) inhibitors (e.g., ritonavir, indinavir, nelfinavir, saquinavir, atazanavir, ketoconazole, itraconazole, voriconazole, fluconazole, cyclosporine, mibefradil, nefazodone, clarithromycin, telithromycin, troleandromycin, norfloxacin, ciprofloxacin) or inducers (e.g. phenobarbital, phenytoin, barbiturates, carbamazepine, oxcarbazepine, rifabutin, rifampin, st john's wort) within 2 weeks prior to screening visit and during the study.
Description

Pharmaceutical Preparations | Herbal medicine | Cytochrome P450 3A4 Inhibitor | Ritonavir | Indinavir | Nelfinavir | Saquinavir | Atazanavir | Ketoconazole | Itraconazole | voriconazole | Fluconazole | Cyclosporine | Mibefradil | nefazodone | Clarithromycin | telithromycin | Troleandomycin | Norfloxacin | Ciprofloxacin | Cytochrome P-450 CYP3A4 Inducers | Phenobarbital | Phenytoin | Barbiturates | Carbamazepine | oxcarbazepine | Rifabutin | Rifampin | Hypericum perforatum

Data type

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C2240391
UMLS CUI [3]
C3830624
UMLS CUI [4]
C0292818
UMLS CUI [5]
C0376637
UMLS CUI [6]
C0525005
UMLS CUI [7]
C0286738
UMLS CUI [8]
C1145759
UMLS CUI [9]
C0022625
UMLS CUI [10]
C0064113
UMLS CUI [11]
C0393080
UMLS CUI [12]
C0016277
UMLS CUI [13]
C0010592
UMLS CUI [14]
C0286185
UMLS CUI [15]
C0068485
UMLS CUI [16]
C0055856
UMLS CUI [17]
C0907410
UMLS CUI [18]
C0041165
UMLS CUI [19]
C0028365
UMLS CUI [20]
C0008809
UMLS CUI [21]
C3850041
UMLS CUI [22]
C0031412
UMLS CUI [23]
C0031507
UMLS CUI [24]
C0004745
UMLS CUI [25]
C0006949
UMLS CUI [26]
C0069751
UMLS CUI [27]
C0140575
UMLS CUI [28]
C0035608
UMLS CUI [29]
C0936242
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Similar models

Eligibility Asthma NCT02227394

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02227394
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female patient ≥ 18 years old.
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
2. written informed consent obtained.
boolean
C0021430 (UMLS CUI [1])
Asthma
Item
3. patient with a documented diagnosis of asthma according to the global initiative for asthma (gina) guidelines
boolean
C0004096 (UMLS CUI [1])
Compliance behavior | Use of Dry Powder Inhaler (device)
Item
4. patient with a co-operative attitude and ability to correctly use the dpi.
boolean
C1321605 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C1967611 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Postmenopausal state | Amenorrhea
Item
5. female patient of childbearing potential who confirm that a reliable method of contraception was used at least 14 days before visit 1 and will continue to use a reliable method of contraception during the study, or post-menopausal women (at least 12 months of amenorrhea)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0002453 (UMLS CUI [3])
Stable status | Therapeutic procedure
Item
6. patient must be stable and treated in accordance with the gina guidelines.
boolean
C0205360 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Non-smoker | Former smoker Stopped smoking smoking cigarettes: ____ pack-years history
Item
7. patient must be a non-smoker or ex-smoker who have stopped smoking at least 1 month prior to visit 1 and has a smoking history of < 10 pack years.
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2,1])
C0425310 (UMLS CUI [2,2])
C2230126 (UMLS CUI [2,3])
Compliance behavior
Item
8. patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Exacerbation of asthma | Unstable status
Item
2. unstable patient who developed an asthma exacerbation in the 4 weeks before screening.
boolean
C0349790 (UMLS CUI [1])
C0443343 (UMLS CUI [2])
Upper Respiratory Infections | Lower respiratory tract infection
Item
3. patient with upper or lower airways infection in the 4 weeks before screening.
boolean
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
Unable Pulmonary function tests
Item
4. patient unable to perform pulmonary function testing.
boolean
C1299582 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Inhaled bronchodilator therapy | Unable Withdraw
Item
5. patients unable to withdraw fixed combination or long acting bronchodilator inhalation products
boolean
C0578554 (UMLS CUI [1])
C1299582 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
Disease Study Subject Participation Status Limited
Item
6. patient with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Malignant neoplasm of lung | Chronic disease Prognosis bad
Item
7. patient with active lung cancer or any other chronic disease with poor prognosis and
boolean
C0242379 (UMLS CUI [1])
C0008679 (UMLS CUI [2,1])
C0278252 (UMLS CUI [2,2])
Chronic disease Affecting Patient status
Item
/or affecting patient status.
boolean
C0008679 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0449437 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Formulation Ingredient
Item
8. patient with allergy, sensitivity or intolerance to study drugs and/ or study drug formulation ingredients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705957 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
Compliance behavior | Patient Non-Compliance
Item
9. patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
boolean
C1321605 (UMLS CUI [1])
C0376405 (UMLS CUI [2])
systemic steroids
Item
10. patient who received systemic corticosteroids within the last 4 weeks prior to visit
boolean
C2825233 (UMLS CUI [1])
Investigational New Drugs | Study Subject Participation Status
Item
11. patient who received any investigational new drug within the last 4 weeks prior to visit 1 and is participating in any clinical trial.
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Substance Use Disorders
Item
12. patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
boolean
C0038586 (UMLS CUI [1])
Chronic Obstructive Airway Disease
Item
13. patient with diagnosis of chronic obstructive pulmonary disease (copd).
boolean
C0024117 (UMLS CUI [1])
Lactose Intolerance | Milk protein allergy
Item
14. patients who has a lactose intolerance or history of allergy to milk proteins.
boolean
C0022951 (UMLS CUI [1])
C3889086 (UMLS CUI [2])
Pharmaceutical Preparations | Herbal medicine | Cytochrome P450 3A4 Inhibitor | Ritonavir | Indinavir | Nelfinavir | Saquinavir | Atazanavir | Ketoconazole | Itraconazole | voriconazole | Fluconazole | Cyclosporine | Mibefradil | nefazodone | Clarithromycin | telithromycin | Troleandomycin | Norfloxacin | Ciprofloxacin | Cytochrome P-450 CYP3A4 Inducers | Phenobarbital | Phenytoin | Barbiturates | Carbamazepine | oxcarbazepine | Rifabutin | Rifampin | Hypericum perforatum
Item
15. patients treated with medications or herbal medicines that are strong cytochrome p450 3a4 (cyp3a4) inhibitors (e.g., ritonavir, indinavir, nelfinavir, saquinavir, atazanavir, ketoconazole, itraconazole, voriconazole, fluconazole, cyclosporine, mibefradil, nefazodone, clarithromycin, telithromycin, troleandromycin, norfloxacin, ciprofloxacin) or inducers (e.g. phenobarbital, phenytoin, barbiturates, carbamazepine, oxcarbazepine, rifabutin, rifampin, st john's wort) within 2 weeks prior to screening visit and during the study.
boolean
C0013227 (UMLS CUI [1])
C2240391 (UMLS CUI [2])
C3830624 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
C0376637 (UMLS CUI [5])
C0525005 (UMLS CUI [6])
C0286738 (UMLS CUI [7])
C1145759 (UMLS CUI [8])
C0022625 (UMLS CUI [9])
C0064113 (UMLS CUI [10])
C0393080 (UMLS CUI [11])
C0016277 (UMLS CUI [12])
C0010592 (UMLS CUI [13])
C0286185 (UMLS CUI [14])
C0068485 (UMLS CUI [15])
C0055856 (UMLS CUI [16])
C0907410 (UMLS CUI [17])
C0041165 (UMLS CUI [18])
C0028365 (UMLS CUI [19])
C0008809 (UMLS CUI [20])
C3850041 (UMLS CUI [21])
C0031412 (UMLS CUI [22])
C0031507 (UMLS CUI [23])
C0004745 (UMLS CUI [24])
C0006949 (UMLS CUI [25])
C0069751 (UMLS CUI [26])
C0140575 (UMLS CUI [27])
C0035608 (UMLS CUI [28])
C0936242 (UMLS CUI [29])
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