0 Avaliações
ID

37244

Descrição

Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02340130

Link

https://clinicaltrials.gov/show/NCT02340130

Palavras-chave

Versões (1)
  1. 11/07/2019 11/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Rhinitis NCT02340130

    Inglês

    Eligibility Rhinitis NCT02340130

    1 Formulários  
    1. StudyEvent: Eligibility
      1. Eligibility Rhinitis NCT02340130
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. subject has provided appropriately signed and dated written informed consent.
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    2. men and women aged 18 years and 70 years of age at visit 1.
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. has an fev1 value 80% of predicted normal value at visit 1.
    Descrição

    Percent predicted FEV1

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0730561
    4. individuals suffering from perennial allergic rhinitis or rhinoconjunctivitis moderate-severe for at least the preceding year, with controlled asthma, caused by double sensitization against dermatophagoides pteronyssinus (dpt) and lepidoglyphus destructor or dermatophagoides pteronyssinus and blomia tropicalis.
    Descrição

    Rhinitis, Allergic, Perennial | Rhinoconjunctivitis Moderate | Rhinoconjunctivitis Severe | Asthma well controlled | Sensitization Double | Sensitization Against Dermatophagoides pteronyssinus | Sensitization Against Lepidoglyphus destructor | Sensitization Against Blomia tropicalis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0035457
    UMLS CUI [2,1]
    C0861155
    UMLS CUI [2,2]
    C0205081
    UMLS CUI [3,1]
    C0861155
    UMLS CUI [3,2]
    C0205082
    UMLS CUI [4]
    C4296063
    UMLS CUI [5,1]
    C0597749
    UMLS CUI [5,2]
    C0205173
    UMLS CUI [6,1]
    C0597749
    UMLS CUI [6,2]
    C0521124
    UMLS CUI [6,3]
    C1122992
    UMLS CUI [7,1]
    C0597749
    UMLS CUI [7,2]
    C0521124
    UMLS CUI [7,3]
    C0446326
    UMLS CUI [8,1]
    C0597749
    UMLS CUI [8,2]
    C0521124
    UMLS CUI [8,3]
    C1009020
    5. patients sensitized to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelials cannot participate in the study if they are symptomatic.
    Descrição

    Sensitization Allergens | Patients Symptomatic Excluded | Tree pollen | Grasses | Weeds | Fungi | Other Coding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0597749
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [2,1]
    C0030705
    UMLS CUI [2,2]
    C0231220
    UMLS CUI [2,3]
    C0332196
    UMLS CUI [3]
    C0440366
    UMLS CUI [4]
    C0018210
    UMLS CUI [5]
    C2936212
    UMLS CUI [6]
    C0016832
    UMLS CUI [7]
    C3846158
    6. if a female is of non-childbearing potential, the subject must be postmenopausal for at least 1 year or surgically sterile.
    Descrição

    Childbearing Potential Absent | Postmenopausal state | Female Sterilization

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2]
    C0232970
    UMLS CUI [3]
    C0015787
    7. if a female is of childbearing potential, the subject must be non-lactating and non-pregnant and must correctly use an effective method of contraception during the study.
    Descrição

    Childbearing Potential Breast Feeding Absent | Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0006147
    UMLS CUI [1,3]
    C0332197
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0032961
    UMLS CUI [2,3]
    C0332197
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. any contraindication for treatment with allergen specific immunotherapy.
    Descrição

    Medical contraindication Immunotherapy Allergen Specific

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0021083
    UMLS CUI [1,3]
    C0002092
    UMLS CUI [1,4]
    C0205369
    2. subjects with a previous history of anaphylaxis.
    Descrição

    Anaphylaxis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0002792
    3. patients with hospital admission due to asthma exacerbations within 1 year prior to v1.
    Descrição

    Hospital admission Due to Exacerbation of asthma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0184666
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C0349790
    4. has uncontrolled asthma, according to global initiative for asthma guidelines (gina 2010).
    Descrição

    Asthma Uncontrolled

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C0205318
    5. acute or chronic infectious conjunctivitis.
    Descrição

    Acute infectious conjunctivitis | Infective conjunctivitis chronic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C4304387
    UMLS CUI [2,1]
    C0497209
    UMLS CUI [2,2]
    C0205191
    6. has acute or chronic inflammatory or infectious airways disease.
    Descrição

    Inflammatory disorder | Chronic inflammatory disorder | Airway disease infectious | Airway disease infectious chronic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1290884
    UMLS CUI [2]
    C1290886
    UMLS CUI [3,1]
    C0699949
    UMLS CUI [3,2]
    C0009450
    UMLS CUI [4,1]
    C0699949
    UMLS CUI [4,2]
    C0009450
    UMLS CUI [4,3]
    C0205191
    7. has chronic structural diseases of the affected organ (e.g. eye, nose, lung).
    Descrição

    Disease structural chronic | Disease Organ Affected | Disease structural chronic Eye | Disease structural chronic Nose | Disease structural chronic Lung

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0678594
    UMLS CUI [1,3]
    C0205191
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0178784
    UMLS CUI [2,3]
    C0392760
    UMLS CUI [3,1]
    C0012634
    UMLS CUI [3,2]
    C0678594
    UMLS CUI [3,3]
    C0205191
    UMLS CUI [3,4]
    C0015392
    UMLS CUI [4,1]
    C0012634
    UMLS CUI [4,2]
    C0678594
    UMLS CUI [4,3]
    C0205191
    UMLS CUI [4,4]
    C0028429
    UMLS CUI [5,1]
    C0012634
    UMLS CUI [5,2]
    C0678594
    UMLS CUI [5,3]
    C0205191
    UMLS CUI [5,4]
    C0024109
    8. history or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance.
    Descrição

    Immune System Diseases | Autoimmune Diseases | Immunodeficiency

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021053
    UMLS CUI [2]
    C0004364
    UMLS CUI [3]
    C0021051
    9. has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).
    Descrição

    Disease Excludes Epinephrine | Hyperthyroidism

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0332196
    UMLS CUI [1,3]
    C0014563
    UMLS CUI [2]
    C0020550
    10. has a severe uncontrolled disease that could increase the risk to the subjects while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disord
    Descrição

    Disease Severe Uncontrolled | Study Subject Participation Status At risk | Cardiovascular insufficiency | Lung disease Severe | Lung disease Unstable | Endocrine System Diseases | Kidney Diseases | Liver diseases | Hematological Disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0205318
    UMLS CUI [2,1]
    C2348568
    UMLS CUI [2,2]
    C1444641
    UMLS CUI [3]
    C1392046
    UMLS CUI [4,1]
    C0024115
    UMLS CUI [4,2]
    C0205082
    UMLS CUI [5,1]
    C0024115
    UMLS CUI [5,2]
    C0443343
    UMLS CUI [6]
    C0014130
    UMLS CUI [7]
    C0022658
    UMLS CUI [8]
    C0023895
    UMLS CUI [9]
    C0018939
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    Similar models

    Eligibility Rhinitis NCT02340130

    1 Formulários
    1. StudyEvent: Eligibility
      1. Eligibility Rhinitis NCT02340130
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    1. subject has provided appropriately signed and dated written informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Age
    Item
    2. men and women aged 18 years and 70 years of age at visit 1.
    boolean
    C0001779 (UMLS CUI [1])
    Percent predicted FEV1
    Item
    3. has an fev1 value 80% of predicted normal value at visit 1.
    boolean
    C0730561 (UMLS CUI [1])
    Rhinitis, Allergic, Perennial | Rhinoconjunctivitis Moderate | Rhinoconjunctivitis Severe | Asthma well controlled | Sensitization Double | Sensitization Against Dermatophagoides pteronyssinus | Sensitization Against Lepidoglyphus destructor | Sensitization Against Blomia tropicalis
    Item
    4. individuals suffering from perennial allergic rhinitis or rhinoconjunctivitis moderate-severe for at least the preceding year, with controlled asthma, caused by double sensitization against dermatophagoides pteronyssinus (dpt) and lepidoglyphus destructor or dermatophagoides pteronyssinus and blomia tropicalis.
    boolean
    C0035457 (UMLS CUI [1])
    C0861155 (UMLS CUI [2,1])
    C0205081 (UMLS CUI [2,2])
    C0861155 (UMLS CUI [3,1])
    C0205082 (UMLS CUI [3,2])
    C4296063 (UMLS CUI [4])
    C0597749 (UMLS CUI [5,1])
    C0205173 (UMLS CUI [5,2])
    C0597749 (UMLS CUI [6,1])
    C0521124 (UMLS CUI [6,2])
    C1122992 (UMLS CUI [6,3])
    C0597749 (UMLS CUI [7,1])
    C0521124 (UMLS CUI [7,2])
    C0446326 (UMLS CUI [7,3])
    C0597749 (UMLS CUI [8,1])
    C0521124 (UMLS CUI [8,2])
    C1009020 (UMLS CUI [8,3])
    Sensitization Allergens | Patients Symptomatic Excluded | Tree pollen | Grasses | Weeds | Fungi | Other Coding
    Item
    5. patients sensitized to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelials cannot participate in the study if they are symptomatic.
    boolean
    C0597749 (UMLS CUI [1,1])
    C0002092 (UMLS CUI [1,2])
    C0030705 (UMLS CUI [2,1])
    C0231220 (UMLS CUI [2,2])
    C0332196 (UMLS CUI [2,3])
    C0440366 (UMLS CUI [3])
    C0018210 (UMLS CUI [4])
    C2936212 (UMLS CUI [5])
    C0016832 (UMLS CUI [6])
    C3846158 (UMLS CUI [7])
    Childbearing Potential Absent | Postmenopausal state | Female Sterilization
    Item
    6. if a female is of non-childbearing potential, the subject must be postmenopausal for at least 1 year or surgically sterile.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0232970 (UMLS CUI [2])
    C0015787 (UMLS CUI [3])
    Childbearing Potential Breast Feeding Absent | Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods
    Item
    7. if a female is of childbearing potential, the subject must be non-lactating and non-pregnant and must correctly use an effective method of contraception during the study.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    C3831118 (UMLS CUI [2,1])
    C0032961 (UMLS CUI [2,2])
    C0332197 (UMLS CUI [2,3])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Medical contraindication Immunotherapy Allergen Specific
    Item
    1. any contraindication for treatment with allergen specific immunotherapy.
    boolean
    C1301624 (UMLS CUI [1,1])
    C0021083 (UMLS CUI [1,2])
    C0002092 (UMLS CUI [1,3])
    C0205369 (UMLS CUI [1,4])
    Anaphylaxis
    Item
    2. subjects with a previous history of anaphylaxis.
    boolean
    C0002792 (UMLS CUI [1])
    Hospital admission Due to Exacerbation of asthma
    Item
    3. patients with hospital admission due to asthma exacerbations within 1 year prior to v1.
    boolean
    C0184666 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C0349790 (UMLS CUI [1,3])
    Asthma Uncontrolled
    Item
    4. has uncontrolled asthma, according to global initiative for asthma guidelines (gina 2010).
    boolean
    C0004096 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Acute infectious conjunctivitis | Infective conjunctivitis chronic
    Item
    5. acute or chronic infectious conjunctivitis.
    boolean
    C4304387 (UMLS CUI [1])
    C0497209 (UMLS CUI [2,1])
    C0205191 (UMLS CUI [2,2])
    Inflammatory disorder | Chronic inflammatory disorder | Airway disease infectious | Airway disease infectious chronic
    Item
    6. has acute or chronic inflammatory or infectious airways disease.
    boolean
    C1290884 (UMLS CUI [1])
    C1290886 (UMLS CUI [2])
    C0699949 (UMLS CUI [3,1])
    C0009450 (UMLS CUI [3,2])
    C0699949 (UMLS CUI [4,1])
    C0009450 (UMLS CUI [4,2])
    C0205191 (UMLS CUI [4,3])
    Disease structural chronic | Disease Organ Affected | Disease structural chronic Eye | Disease structural chronic Nose | Disease structural chronic Lung
    Item
    7. has chronic structural diseases of the affected organ (e.g. eye, nose, lung).
    boolean
    C0012634 (UMLS CUI [1,1])
    C0678594 (UMLS CUI [1,2])
    C0205191 (UMLS CUI [1,3])
    C0012634 (UMLS CUI [2,1])
    C0178784 (UMLS CUI [2,2])
    C0392760 (UMLS CUI [2,3])
    C0012634 (UMLS CUI [3,1])
    C0678594 (UMLS CUI [3,2])
    C0205191 (UMLS CUI [3,3])
    C0015392 (UMLS CUI [3,4])
    C0012634 (UMLS CUI [4,1])
    C0678594 (UMLS CUI [4,2])
    C0205191 (UMLS CUI [4,3])
    C0028429 (UMLS CUI [4,4])
    C0012634 (UMLS CUI [5,1])
    C0678594 (UMLS CUI [5,2])
    C0205191 (UMLS CUI [5,3])
    C0024109 (UMLS CUI [5,4])
    Immune System Diseases | Autoimmune Diseases | Immunodeficiency
    Item
    8. history or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance.
    boolean
    C0021053 (UMLS CUI [1])
    C0004364 (UMLS CUI [2])
    C0021051 (UMLS CUI [3])
    Disease Excludes Epinephrine | Hyperthyroidism
    Item
    9. has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).
    boolean
    C0012634 (UMLS CUI [1,1])
    C0332196 (UMLS CUI [1,2])
    C0014563 (UMLS CUI [1,3])
    C0020550 (UMLS CUI [2])
    Disease Severe Uncontrolled | Study Subject Participation Status At risk | Cardiovascular insufficiency | Lung disease Severe | Lung disease Unstable | Endocrine System Diseases | Kidney Diseases | Liver diseases | Hematological Disease
    Item
    10. has a severe uncontrolled disease that could increase the risk to the subjects while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disord
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0205318 (UMLS CUI [1,3])
    C2348568 (UMLS CUI [2,1])
    C1444641 (UMLS CUI [2,2])
    C1392046 (UMLS CUI [3])
    C0024115 (UMLS CUI [4,1])
    C0205082 (UMLS CUI [4,2])
    C0024115 (UMLS CUI [5,1])
    C0443343 (UMLS CUI [5,2])
    C0014130 (UMLS CUI [6])
    C0022658 (UMLS CUI [7])
    C0023895 (UMLS CUI [8])
    C0018939 (UMLS CUI [9])
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