ID

37244

Descripción

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

Palabras clave

Versiones (1)
  1. 11/7/19 11/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de julio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Rhinitis NCT02340130

Inglés

Eligibility Rhinitis NCT02340130

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Rhinitis NCT02340130
Inclusion Criteria
Descripción

Inclusion Criteria

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

Informed Consent

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Percent predicted FEV1

Tipo de datos

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.
Descripción

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 datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Childbearing Potential Absent | Postmenopausal state | Female Sterilization

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

Exclusion Criteria

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

Medical contraindication Immunotherapy Allergen Specific

Tipo de datos

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.
Descripción

Anaphylaxis

Tipo de datos

boolean

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

Hospital admission Due to Exacerbation of asthma

Tipo de datos

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).
Descripción

Asthma Uncontrolled

Tipo de datos

boolean

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

Acute infectious conjunctivitis | Infective conjunctivitis chronic

Tipo de datos

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.
Descripción

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

Tipo de datos

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).
Descripción

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

Tipo de datos

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.
Descripción

Immune System Diseases | Autoimmune Diseases | Immunodeficiency

Tipo de datos

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).
Descripción

Disease Excludes Epinephrine | Hyperthyroidism

Tipo de datos

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
Descripción

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 datos

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 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Rhinitis NCT02340130
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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