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Informações:
Falhas:
ID
14197
Descrição
Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate TwinCaps® DPI in Adults With Chronic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02022761
Link
https://clinicaltrials.gov/show/NCT02022761
Palavras-chave
Versões (2)
- 04/04/2016 04/04/2016 -
- 20/09/2021 20/09/2021 -
Transferido a
4 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Asthma NCT02022761
Eligibility Asthma NCT02022761
- StudyEvent: Eligibility
Similar models
Eligibility Asthma NCT02022761
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age | Gender | Healthy Volunteers
Item
1. healthy male or female subjects 18 to 65 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C1708335 (UMLS CUI [2,2])
C0079399 (UMLS CUI [2,1])
C1708335 (UMLS CUI [2,2])
Body mass index
Item
2. body mass index (bmi) within the range of 19.0 to 33.0 kg/m2, inclusive at screening
boolean
C1305855 (UMLS CUI [1])
Body weight | Pre-dose | day
Item
3. minimum weight of 55.0 kg at screening and pre-dose day 1
boolean
C0005910 (UMLS CUI [1])
C0439565 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
C0439565 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Asthma confirmed
Item
4. clinical diagnosis of asthma by a physician for ≥12 months prior to screening confirmed in writing and/or by medical records
boolean
C0004096 (UMLS CUI [1,1])
C3173473 (UMLS CUI [1,2])
C3173473 (UMLS CUI [1,2])
Mild asthma | Low-Dose Treatment | inhaled steroids | Moderate asthma | inhaled steroids | Adrenergic beta-2 Receptor Agonists
Item
5. mild asthmatics currently requiring treatment with low dose inhaled corticosteroids or other low intensity treatment or moderate asthmatics, requiring treatment with low dose inhaled corticosteroids and long-acting beta agonists, medium- high dose inhaled corticosteroids alone or low dose inhaled corticosteroids and other low intensity treatment8
boolean
C0581124 (UMLS CUI [1])
C1708745 (UMLS CUI [2,1])
C2065041 (UMLS CUI [2,2])
C0581125 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C2936789 (UMLS CUI [3,3])
C1708745 (UMLS CUI [2,1])
C2065041 (UMLS CUI [2,2])
C0581125 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C2936789 (UMLS CUI [3,3])
Persistent asthma, well controlled
Item
6. well controlled asthma for 1 month prior to dosing defined by the following:
boolean
C3661869 (UMLS CUI [1])
Asthma daytime symptoms
Item
1. daytime symptoms occur ≤8 times/ 4 weeks
boolean
C1276804 (UMLS CUI [1])
Asthma | daily activities | Limited
Item
2. daily activity is not limited by asthma
boolean
C0004096 (UMLS CUI [1])
C0871707 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0871707 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Asthma night-time symptoms | Nocturnal awakening
Item
3. no nocturnal symptoms resulting in nighttime awakenings
boolean
C1273489 (UMLS CUI [1])
C0860510 (UMLS CUI [2])
C0860510 (UMLS CUI [2])
Adrenergic beta-2 Receptor Agonists | treat symptoms
Item
4. use of short-acting beta-agonist (saba) ≤8 times/4 weeks for the treatment of symptoms
boolean
C2936789 (UMLS CUI [1,1])
C2146147 (UMLS CUI [1,2])
C2146147 (UMLS CUI [1,2])
Asthma | Change of medication
Item
7. there has been no change in asthma medication (dose or regimen) within 4 weeks prior to dosing
boolean
C0004096 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
C0580105 (UMLS CUI [1,2])
Adrenergic beta-2 Receptor Agonists | FEV1
Item
8. pre-short-acting β2 agonist (saba) forced expiratory volume in 1 second (fev1) of
boolean
C2936789 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C0748133 (UMLS CUI [2])
FEV1
Item
≥80 percent of predicted normal values at screening
boolean
C0748133 (UMLS CUI [1])
Non-smoker
Item
9. non-smokers for at least 6 months prior to screening and agrees not to smoke during the study
boolean
C0337672 (UMLS CUI [1])
Smoking Status | Negative Test Result | Urine cotinine test negative
Item
10. negative test results for smoking status at screening (urine cotinine) and pre-dose day 1 (smokerlyser)
boolean
C1519386 (UMLS CUI [1,1])
C1334932 (UMLS CUI [1,2])
C1696067 (UMLS CUI [2])
C1334932 (UMLS CUI [1,2])
C1696067 (UMLS CUI [2])
Childbearing Potential | periodic abstinence | Rhythm method of contraception | Ovulation Inhibition | Temperature method of contraception | Withdrawal - birth control | Contraceptive methods | Hormonal contraception
Item
11. female subjects of childbearing potential must be practising true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence, e.g. calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception), or be using and willing to continue using a medically acceptable form of birth control for at least 1 month prior to screening (at least 3 months for hormonal contraceptives) and for at least 1 month after the last study drug administration
boolean
C3831118 (UMLS CUI [1])
C1256761 (UMLS CUI [2])
C0035513 (UMLS CUI [3])
C0029968 (UMLS CUI [4])
C0419534 (UMLS CUI [5])
C3812880 (UMLS CUI [6])
C0700589 (UMLS CUI [7])
C2985296 (UMLS CUI [8])
C1256761 (UMLS CUI [2])
C0035513 (UMLS CUI [3])
C0029968 (UMLS CUI [4])
C0419534 (UMLS CUI [5])
C3812880 (UMLS CUI [6])
C0700589 (UMLS CUI [7])
C2985296 (UMLS CUI [8])
Male Contraception | Females & males of reproductive potential
Item
12. male subjects of reproductive potential who are not truly abstinent must be using and willing to continue using medically acceptable contraceptive precautions from screening and for at least 1 month after the last study drug administration
boolean
C0086580 (UMLS CUI [1])
C4034483 (UMLS CUI [2])
C4034483 (UMLS CUI [2])
Female | Serum pregnancy test negative | Urine pregnancy test negative
Item
13. female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test pre-dose day 1
boolean
C0015780 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0430057 (UMLS CUI [1,3])
C0430061 (UMLS CUI [1,2])
C0430057 (UMLS CUI [1,3])
Able to speak | Able to read | Comprehension | English Language | Informed Consent | Compliance behavior
Item
14. able to speak, read, and understand english sufficiently to understand the nature of the study, to provide informed consent, and to allow completion of all study assessments
boolean
C0564215 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0376245 (UMLS CUI [1,4])
C0021430 (UMLS CUI [2])
C1321605 (UMLS CUI [3])
C0586740 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0376245 (UMLS CUI [1,4])
C0021430 (UMLS CUI [2])
C1321605 (UMLS CUI [3])
Informed consent
Item
15. must provide written informed consent prior to the initiation of any protocol-specific procedures
boolean
C0021430 (UMLS CUI [1])
Exacerbation of asthma | Life Threatening | Intubation | Mechanical ventilation
Item
1. a history of a life-threatening asthma exacerbation that required intubation and mechanical ventilation
boolean
C0349790 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0021925 (UMLS CUI [2,1])
C0199470 (UMLS CUI [2,2])
C2826244 (UMLS CUI [1,2])
C0021925 (UMLS CUI [2,1])
C0199470 (UMLS CUI [2,2])
Exacerbation of severe persistent asthma | systemic steroids
Item
2. history of severe asthma exacerbation in the last year that required the use of systemic corticosteroids (tablets, suspension or injection)
boolean
C3508930 (UMLS CUI [1])
C2825233 (UMLS CUI [2])
C2825233 (UMLS CUI [2])
Hospitalization | previous emergency room visit | Asthma
Item
3. hospitalization or a visit to er because of asthma in the last year
boolean
C0019993 (UMLS CUI [1])
C2114437 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C2114437 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
Asthma | Admission to intensive care unit
Item
4. intensive care admission for asthma in the previous 5 years
boolean
C0004096 (UMLS CUI [1,1])
C0583239 (UMLS CUI [1,2])
C0583239 (UMLS CUI [1,2])
Abnormality | Chemistry, Clinical | Hematology finding | Urinalysis
Item
5. any clinically significant abnormalities on clinical chemistry, haematology, or urinalysis, as judged by the investigator (at screening and/or day -1)
boolean
C1704258 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2])
C0042014 (UMLS CUI [3])
C0008000 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2])
C0042014 (UMLS CUI [3])
Abnormality | Physical Examination | Medical History | 12 lead ECG | Vital signs
Item
6. clinically significant abnormalities on physical examination, medical history, 12-lead ecg, or vital signs, as judged by the investigator (at screening or pre-dose day 1)
boolean
C1704258 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0430456 (UMLS CUI [3])
C0518766 (UMLS CUI [4])
C0031809 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0430456 (UMLS CUI [3])
C0518766 (UMLS CUI [4])
QTcF | Gender | Electrocardiogram
Item
7. a qtcf >430 msec for male subjects and >450 msec for female subjects on ecg at screening or pre-dose day 1
boolean
C1882513 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
C0079399 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
Illness (finding) | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Immune System Diseases | Dermatologic disorders | nervous system disorder | Malignant Neoplasms | Musculoskeletal Diseases | Mental disorders | Compliance behavior
Item
8. history or presence of any clinically significant illness (e.g., cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results
boolean
C0221423 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0021053 (UMLS CUI [8])
C0037274 (UMLS CUI [9])
C0027765 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
C0026857 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
C1321605 (UMLS CUI [14])
C0007222 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0021053 (UMLS CUI [8])
C0037274 (UMLS CUI [9])
C0027765 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
C0026857 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
C1321605 (UMLS CUI [14])
Other respiratory system diseases | Chronic Obstructive Airway Disease | Cystic Fibrosis
Item
9. history or clinical evidence of other respiratory disease (e.g., copd, cystic fibrosis)
boolean
C0029582 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
C0010674 (UMLS CUI [3])
C0024117 (UMLS CUI [2])
C0010674 (UMLS CUI [3])
Respiratory Tract Infections
Item
10. recent (within 2 weeks) or current signs or symptoms of a respiratory infection at screening or pre-dose day 1
boolean
C0035243 (UMLS CUI [1])
Theophylline
Item
11. currently taking theophylline or has taken theophylline in the 3 months prior to screening
boolean
C0039771 (UMLS CUI [1])
Drugs, Non-Prescription
Item
12. use of non-prescription drugs within 3 days prior to day 1
boolean
C0013231 (UMLS CUI [1])
Prescription Drugs | Pharmaceutical Preparations | Asthma | Contraceptive methods | Hormone replacement therapy | Recreational Drugs
Item
13. use of prescription medications (except acceptable asthma medications, acceptable forms of birth control, and hormone replacement) and recreational drugs within 14 days prior to day 1
boolean
C0304227 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3])
C0282402 (UMLS CUI [4])
C0242508 (UMLS CUI [5])
C0013227 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3])
C0282402 (UMLS CUI [4])
C0242508 (UMLS CUI [5])
Urine drug screen positive | Ethanol measurement, breath
Item
14. positive urine drug screen or breath alcohol test at screening or pre-dose day 1
boolean
C0743300 (UMLS CUI [1])
C0202306 (UMLS CUI [2])
C0202306 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
15. female subjects who are pregnant or lactating or who are planning to become pregnant within 30 days of study drug administration
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Hypersensitivity | Lactose | Neuraminidase
Item
16. history of allergy, hypersensitivity, or serious adverse reaction to lactose or neuraminidase inhibitors
boolean
C0020517 (UMLS CUI [1,1])
C0022949 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0027803 (UMLS CUI [2,2])
C0022949 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0027803 (UMLS CUI [2,2])
Exposure to | laninamivir octanoate
Item
17. previous exposure to laninamivir octanoate
boolean
C0332157 (UMLS CUI [1,1])
C3530114 (UMLS CUI [1,2])
C3530114 (UMLS CUI [1,2])
Positive | Hepatitis B Surface Antigens | Hepatitis C Antibodies | HIV Core Protein p24
Item
18. positive for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus (hiv) p24 antigen/antibodies at screening
boolean
C1446409 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
C0166049 (UMLS CUI [2])
C0085219 (UMLS CUI [3])
C0019168 (UMLS CUI [1,2])
C0166049 (UMLS CUI [2])
C0085219 (UMLS CUI [3])
whole blood | Blood Donation | Hemorrhage
Item
19. donation or loss of ≥500 ml whole blood within 2 months prior to day 1
boolean
C0370231 (UMLS CUI [1,1])
C0005794 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2])
C0005794 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2])
charge amounts | On probation
Item
20. current or pending legal charges or currently on probation, based on subject report
boolean
C0007961 (UMLS CUI [1])
C0425169 (UMLS CUI [2])
C0425169 (UMLS CUI [2])
Investigational New Drugs
Item
21. receipt of an investigational product in a clinical trial within 30 days or 5 half-lives, whichever is longer, prior to day 1
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status | Compliance behavior
Item
22. concurrent enrolment in any other type of medical research, judged by the investigator not to be scientifically or medically compatible with this study
boolean
C2348568 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
C1321605 (UMLS CUI [2])
Employee | Clinical Study Sponsor
Item
23. an employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted
boolean
C0599987 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,2])
Compliance behavior
Item
24. a subject who, in the opinion of the investigator, is not considered to be suitable and is unlikely to comply with the study protocol for any reason
boolean
C1321605 (UMLS CUI [1])