ID

14135

Beschreibung

Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01930461

Link

https://clinicaltrials.gov/show/NCT01930461

Stichworte

Versionen (1)
  1. 31.03.16 31.03.16 -
Hochgeladen am

31. März 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Asthma NCT01930461

Englisch

Eligibility Asthma NCT01930461

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01930461
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
male or female from 18 to 50 years of age.
Beschreibung

Age | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
diagnosed asthma and rhinitis with medical history consistent with hdm-induced allergic asthma and rhinitis.
Beschreibung

Asthma | Rhinitis | house dust mites | Allergic asthma | Allergic rhinitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0035455
UMLS CUI [3,1]
C3539110
UMLS CUI [3,2]
C0155877
UMLS CUI [4,1]
C3539110
UMLS CUI [4,2]
C2607914
positive spt to hdm and and hdm-specific ige serum value ≥ 0.7 ku/l.
Beschreibung

Skin prick test | house dust mites | serum IgE measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430561
UMLS CUI [1,2]
C3539110
UMLS CUI [2]
C2229760
stable asthma therapies.
Beschreibung

Asthma therapy | Stable status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0205360
spirometry (pre-bronchodilator) with best fev1 ≥ 70 percent of the predicted value.
Beschreibung

FEV1 | Spirometry | pre bronchodilator

Datentyp

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2,1]
C0037981
UMLS CUI [2,2]
C2599602
spirometry with reversibility in fev1 of ≥ 12 percent and ≥ 200 ml.
Beschreibung

Spirometry reversibility | FEV1

Datentyp

boolean

Alias
UMLS CUI [1]
C1272658
UMLS CUI [2]
C0748133
asthma control test™ (act) score ≤ 19.
Beschreibung

Asthma control test score

Datentyp

boolean

Alias
UMLS CUI [1]
C2733224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
former smoker with > 10 pack year history or current smoker.
Beschreibung

Former smoker | pack-years history | Current Smoker

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C2230126
UMLS CUI [2]
C3241966
patient with a urine level of cotinine ≥ 500 ng/ml.
Beschreibung

urine continine measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C2188552
co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
Beschreibung

Sensitization | Allergens | Asthma | Symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1325847
UMLS CUI [1,2]
C0002092
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0004096
UMLS CUI [2,3]
C1457887
patient who received allergen immunotherapy for hdm within the past 10 years.
Beschreibung

Allergen Immunotherapy | house dust mites

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162352
UMLS CUI [1,2]
C3539110
ongoing immunotherapy for an aeroallergen other than house dust mite.
Beschreibung

Immunotherapy | Aeroallergen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0001697
UMLS CUI [2]
C3539110
patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
Beschreibung

condition of oral cavity | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2010703
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0549076
UMLS CUI [4]
C0040440
patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (maois).
Beschreibung

Therapeutic procedure | Adrenergic beta-1 Receptor Antagonists | Tricyclic Antidepressive Agents | Monoamine Oxidase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0304516
UMLS CUI [2]
C0003290
UMLS CUI [3]
C0026457
pregnant women or breast-feeding/lactating.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women with childbearing potential who are not using a medically accepted birth control method.
Beschreibung

Woman | Childbearing Potential | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C3831118
UMLS CUI [2]
C0700589
patient with a past or current disease, which as judged by the investigator, may affect the patient's participation in, or the outcome of this study.
Beschreibung

Disease | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
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Ähnliche Modelle

Eligibility Asthma NCT01930461

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01930461
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age | Gender
Item
male or female from 18 to 50 years of age.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Asthma | Rhinitis | house dust mites | Allergic asthma | Allergic rhinitis
Item
diagnosed asthma and rhinitis with medical history consistent with hdm-induced allergic asthma and rhinitis.
boolean
C0004096 (UMLS CUI [1])
C0035455 (UMLS CUI [2])
C3539110 (UMLS CUI [3,1])
C0155877 (UMLS CUI [3,2])
C3539110 (UMLS CUI [4,1])
C2607914 (UMLS CUI [4,2])
Skin prick test | house dust mites | serum IgE measurement
Item
positive spt to hdm and and hdm-specific ige serum value ≥ 0.7 ku/l.
boolean
C0430561 (UMLS CUI [1,1])
C3539110 (UMLS CUI [1,2])
C2229760 (UMLS CUI [2])
Asthma therapy | Stable status
Item
stable asthma therapies.
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
FEV1 | Spirometry | pre bronchodilator
Item
spirometry (pre-bronchodilator) with best fev1 ≥ 70 percent of the predicted value.
boolean
C0748133 (UMLS CUI [1])
C0037981 (UMLS CUI [2,1])
C2599602 (UMLS CUI [2,2])
Spirometry reversibility | FEV1
Item
spirometry with reversibility in fev1 of ≥ 12 percent and ≥ 200 ml.
boolean
C1272658 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
Asthma control test score
Item
asthma control test™ (act) score ≤ 19.
boolean
C2733224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Former smoker | pack-years history | Current Smoker
Item
former smoker with > 10 pack year history or current smoker.
boolean
C0337671 (UMLS CUI [1,1])
C2230126 (UMLS CUI [1,2])
C3241966 (UMLS CUI [2])
urine continine measurement
Item
patient with a urine level of cotinine ≥ 500 ng/ml.
boolean
C2188552 (UMLS CUI [1])
Sensitization | Allergens | Asthma | Symptoms
Item
co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
boolean
C1325847 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Allergen Immunotherapy | house dust mites
Item
patient who received allergen immunotherapy for hdm within the past 10 years.
boolean
C0162352 (UMLS CUI [1,1])
C3539110 (UMLS CUI [1,2])
Immunotherapy | Aeroallergen
Item
ongoing immunotherapy for an aeroallergen other than house dust mite.
boolean
C0021083 (UMLS CUI [1,1])
C0001697 (UMLS CUI [1,2])
C3539110 (UMLS CUI [2])
condition of oral cavity | Study Subject Participation Status
Item
patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
boolean
C2010703 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0549076 (UMLS CUI [3])
C0040440 (UMLS CUI [4])
Therapeutic procedure | Adrenergic beta-1 Receptor Antagonists | Tricyclic Antidepressive Agents | Monoamine Oxidase Inhibitors
Item
patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (maois).
boolean
C0087111 (UMLS CUI [1,1])
C0304516 (UMLS CUI [1,2])
C0003290 (UMLS CUI [2])
C0026457 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant women or breast-feeding/lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Woman | Childbearing Potential | Contraceptive methods
Item
women with childbearing potential who are not using a medically accepted birth control method.
boolean
C0043210 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
Disease | Study Subject Participation Status
Item
patient with a past or current disease, which as judged by the investigator, may affect the patient's participation in, or the outcome of this study.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
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