ID

14087

Beschreibung

Distribution of Neutrophils in Bronchial Mucosal Tissue in Asthma Patients Before and After 4 Weeks Treatment With AZD 5069; ODM derived from: https://clinicaltrials.gov/show/NCT01890148

Link

https://clinicaltrials.gov/show/NCT01890148

Stichworte

Versionen (1)
  1. 29.03.16 29.03.16 -
Hochgeladen am

29. März 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Asthma NCT01890148

Englisch

Eligibility Asthma NCT01890148

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01890148
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients of caucasian origin, aged between 18 to 65 years, inclusive, at the time informed consent is obtained.
Beschreibung

Gender | Caucasoid | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0007457
UMLS CUI [1,3]
C0021430
2. physician based (according to gina 2011) diagnosis of asthma for at least 6 months prior to the date informed consent is obtained and confirmed by 1 of the detailed respiratory criteria stated in the csp
Beschreibung

Asthma | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0021430
3. morning prebronchodilator (ie, after abstinence from short-acting and long-acting
Beschreibung

Prebronchodilator | Morning | Abstinence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2599602
UMLS CUI [1,2]
C0332170
UMLS CUI [1,3]
C3843422
ß-agonist treatment for ≥ 6 and ≥ 12 hours, respectively) fev1 of ≥70 percent of predicted normal (pn) for age, sex and height at enrolment
Beschreibung

Beta-agonist | FEV1 | Age | Gender | Body Height

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001644
UMLS CUI [1,2]
C0748133
UMLS CUI [1,3]
C0001779
UMLS CUI [1,4]
C0079399
UMLS CUI [1,5]
C0005890
4. increased number of neutrophils in induced sputum samples at baseline, with a relative neutrophil count of ≥ 50 percent of total sputum cell count
Beschreibung

Neutrophil count | Sputum, Induced | Sputum Total

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948762
UMLS CUI [1,2]
C3179346
UMLS CUI [1,3]
C0200633
UMLS CUI [1,4]
C0038056
UMLS CUI [1,5]
C0439810
UMLS CUI [1,6]
C0007584
5. physician prescribed daily use of medium or high dose ics (≥ fluticasone 250 μg to ≤
Beschreibung

Inhaled steroids used daily | fluticasone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4040610
UMLS CUI [1,2]
C0082607
1.000 µg or the equivalent daily, as defined in gina 2011; see csp appendix e) plus laba.
Beschreibung

Fluticasone | Adrenergic beta-2 Receptor Agonists

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0082607
UMLS CUI [1,2]
C2936789
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of clinically relevant allergies or idiosyncrasies to azd5069 or other investigational cxcr2 antagonists, or any inactive ingredient(s) of the imp, or tool-substances (eg, salbutamol, local anaesthetics) used for the purpose of this study
Beschreibung

Hypersensitivity | AZD5069 | CXCR2 gene antagonists | Salbutamol allergy | Local Anesthetics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4045791
UMLS CUI [2,1]
C1334126
UMLS CUI [2,2]
C0243076
UMLS CUI [3]
C0570955
UMLS CUI [4]
C0002934
2. history of severe asthma exacerbation requiring hospitalization within the last 12 months before screening.
Beschreibung

Exacerbation of severe persistent asthma | Hospitalization Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3508930
UMLS CUI [1,2]
C1708385
3. asthma exacerbation requiring a treatment course of systemic (ie, oral or parenteral) corticosteroids within the 3 months before screening or ≥ 3 courses within the last 12 months before screening.
Beschreibung

Exacerbation of asthma | Treatment required | systemic steroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0332121
UMLS CUI [1,3]
C2825233
UMLS CUI [1,4]
C0001617
UMLS CUI [2]
C1272936
4. moderate to severe airflow limitation (fev1 <70% pn)
Beschreibung

FEV1 | Abnormal airflow

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0232000
UMLS CUI [1,3]
C1881878
UMLS CUI [2]
C0205082
5. any chronic lower respiratory disease other than asthma (see csp for details) that, as judged by the investigator or medical monitor, would interfere with the evaluation of the imp or interpretation of patient safety or study results.
Beschreibung

Chronic lower respiratory disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348692
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C1321605
UMLS CUI [1,4]
C0439801
UMLS CUI [1,5]
C0009488
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Ähnliche Modelle

Eligibility Asthma NCT01890148

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01890148
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Caucasoid | Informed Consent
Item
1. male or female patients of caucasian origin, aged between 18 to 65 years, inclusive, at the time informed consent is obtained.
boolean
C0079399 (UMLS CUI [1,1])
C0007457 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Asthma | Informed Consent
Item
2. physician based (according to gina 2011) diagnosis of asthma for at least 6 months prior to the date informed consent is obtained and confirmed by 1 of the detailed respiratory criteria stated in the csp
boolean
C0004096 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Prebronchodilator | Morning | Abstinence
Item
3. morning prebronchodilator (ie, after abstinence from short-acting and long-acting
boolean
C2599602 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
C3843422 (UMLS CUI [1,3])
Beta-agonist | FEV1 | Age | Gender | Body Height
Item
ß-agonist treatment for ≥ 6 and ≥ 12 hours, respectively) fev1 of ≥70 percent of predicted normal (pn) for age, sex and height at enrolment
boolean
C0001644 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
C0079399 (UMLS CUI [1,4])
C0005890 (UMLS CUI [1,5])
Neutrophil count | Sputum, Induced | Sputum Total
Item
4. increased number of neutrophils in induced sputum samples at baseline, with a relative neutrophil count of ≥ 50 percent of total sputum cell count
boolean
C0948762 (UMLS CUI [1,1])
C3179346 (UMLS CUI [1,2])
C0200633 (UMLS CUI [1,3])
C0038056 (UMLS CUI [1,4])
C0439810 (UMLS CUI [1,5])
C0007584 (UMLS CUI [1,6])
Inhaled steroids used daily | fluticasone
Item
5. physician prescribed daily use of medium or high dose ics (≥ fluticasone 250 μg to ≤
boolean
C4040610 (UMLS CUI [1,1])
C0082607 (UMLS CUI [1,2])
Fluticasone | Adrenergic beta-2 Receptor Agonists
Item
1.000 µg or the equivalent daily, as defined in gina 2011; see csp appendix e) plus laba.
boolean
C0082607 (UMLS CUI [1,1])
C2936789 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity | AZD5069 | CXCR2 gene antagonists | Salbutamol allergy | Local Anesthetics
Item
1. history of clinically relevant allergies or idiosyncrasies to azd5069 or other investigational cxcr2 antagonists, or any inactive ingredient(s) of the imp, or tool-substances (eg, salbutamol, local anaesthetics) used for the purpose of this study
boolean
C0020517 (UMLS CUI [1,1])
C4045791 (UMLS CUI [1,2])
C1334126 (UMLS CUI [2,1])
C0243076 (UMLS CUI [2,2])
C0570955 (UMLS CUI [3])
C0002934 (UMLS CUI [4])
Exacerbation of severe persistent asthma | Hospitalization Required
Item
2. history of severe asthma exacerbation requiring hospitalization within the last 12 months before screening.
boolean
C3508930 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Exacerbation of asthma | Treatment required | systemic steroids
Item
3. asthma exacerbation requiring a treatment course of systemic (ie, oral or parenteral) corticosteroids within the 3 months before screening or ≥ 3 courses within the last 12 months before screening.
boolean
C0349790 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,3])
C0001617 (UMLS CUI [1,4])
C1272936 (UMLS CUI [2])
FEV1 | Abnormal airflow
Item
4. moderate to severe airflow limitation (fev1 <70% pn)
boolean
C0748133 (UMLS CUI [1,1])
C0232000 (UMLS CUI [1,2])
C1881878 (UMLS CUI [1,3])
C0205082 (UMLS CUI [2])
Chronic lower respiratory disease
Item
5. any chronic lower respiratory disease other than asthma (see csp for details) that, as judged by the investigator or medical monitor, would interfere with the evaluation of the imp or interpretation of patient safety or study results.
boolean
C0348692 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0009488 (UMLS CUI [1,5])
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