ID

43530

Beschrijving

Efficacy and Safety of 4 Weeks of Treatment With Inhaled BI 1744 CL in Patients With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00467740

Link

https://clinicaltrials.gov/show/NCT00467740

Trefwoorden

Versies (2)
  1. 12-04-16 12-04-16 -
  2. 20-09-21 20-09-21 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

20 september 2021

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00467740

Engels

Eligibility Asthma NCT00467740

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00467740
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all patients must sign an informed consent consistent with ich-gcp guidelines prior to participation in the trial, which includes medication washout and restrictions
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
2. male or female patients, 18 years of age or older
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. diagnosis of asthma (gina)
Beschrijving

asthma

Datatype

boolean

Alias
UMLS CUI [1]
C0004096
4. pre-bronchodilator fev1 greater than or equal to 60% predicted and <90% predicted (ecsc);
Beschrijving

pre-bronchodilator fev1

Datatype

boolean

Alias
UMLS CUI [1]
C3172227
5. increase in fev1 greater than or equal to 12% and 200 ml 15 minutes after 400µg salbutamol (albuterol) at visit 1
Beschrijving

fev1 salbutamol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0001927
6. patient must have been taking inhaled corticosteroids for at least 12 weeks prior to screening, and must have been receiving a stable low/moderate dose for at least 6 weeks prior to screening.
Beschrijving

inhaled corticosteroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0040223
7. patients must be able to perform technically acceptable pulmonary function tests and pef measurements, and must be able to maintain records (patient daily e-diary) during the study period as required in the protocol
Beschrijving

pulmonary function tests and pef measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2]
C0521299
8. patients must be able to inhale medication in a competent manner from the respimat®
Beschrijving

respimat

Datatype

boolean

inhaler and from a metered dose inhaler (mdi).
Beschrijving

metered dose inhaler

Datatype

boolean

Alias
UMLS CUI [1,1]
C0993596
UMLS CUI [1,2]
C1524063
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with a smoking history of more than 10 pack years
Beschrijving

smoking history

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
2. patients with any of the following conditions: a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 ms), a history of additional risk factors for torsade de pointes (tdp) (e.g., heart failure, hypokalemia, family history of long qt syndrome)
Beschrijving

a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 ms), a history of additional risk factors for torsade de pointes (tdp) (e.g., heart failure, hypokalemia, family history of long qt syndrome)

Datatype

boolean

Alias
UMLS CUI [1]
C0040156
UMLS CUI [2]
C0039236
UMLS CUI [3]
C4478837
UMLS CUI [4,1]
C0040479
UMLS CUI [4,2]
C0035648
3. patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit (visit 1), a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed), a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
Beschrijving

a history of myocardial infarction within 1 year of screening visit (visit 1), a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed), a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0034072
UMLS CUI [4]
C0041296
UMLS CUI [5]
C0006826
UMLS CUI [6,1]
C0001883
UMLS CUI [6,2]
C2826244
UMLS CUI [7]
C0010674
UMLS CUI [8]
C0006267
UMLS CUI [9]
C0038586
4. patients who have undergone thoracotomy with pulmonary resection
Beschrijving

thoracotomy with pulmonary resection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039991
UMLS CUI [1,2]
C0396565
5. patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (visit 1)
Beschrijving

investigational drug

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
6. pregnant or nursing women
Beschrijving

pregnancy or lactation

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. women of childbearing potential not using a highly effective method of birth control. female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least 2 years
Beschrijving

childbearing potential and contraception

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
8. patients who have previously been randomized in this study or are currently participating in another study
Beschrijving

participation status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
9. patients who are unable to comply with pulmonary medication restrictions prior to randomization
Beschrijving

compliance

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Asthma NCT00467740

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00467740
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
1. all patients must sign an informed consent consistent with ich-gcp guidelines prior to participation in the trial, which includes medication washout and restrictions
boolean
C0021430 (UMLS CUI [1])
age
Item
2. male or female patients, 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
asthma
Item
3. diagnosis of asthma (gina)
boolean
C0004096 (UMLS CUI [1])
pre-bronchodilator fev1
Item
4. pre-bronchodilator fev1 greater than or equal to 60% predicted and <90% predicted (ecsc);
boolean
C3172227 (UMLS CUI [1])
fev1 salbutamol
Item
5. increase in fev1 greater than or equal to 12% and 200 ml 15 minutes after 400µg salbutamol (albuterol) at visit 1
boolean
C0748133 (UMLS CUI [1,1])
C0001927 (UMLS CUI [1,2])
inhaled corticosteroids
Item
6. patient must have been taking inhaled corticosteroids for at least 12 weeks prior to screening, and must have been receiving a stable low/moderate dose for at least 6 weeks prior to screening.
boolean
C2065041 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
pulmonary function tests and pef measurement
Item
7. patients must be able to perform technically acceptable pulmonary function tests and pef measurements, and must be able to maintain records (patient daily e-diary) during the study period as required in the protocol
boolean
C0024119 (UMLS CUI [1])
C0521299 (UMLS CUI [2])
respimat
Item
8. patients must be able to inhale medication in a competent manner from the respimat®
boolean
metered dose inhaler
Item
inhaler and from a metered dose inhaler (mdi).
boolean
C0993596 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
smoking history
Item
1. patients with a smoking history of more than 10 pack years
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 ms), a history of additional risk factors for torsade de pointes (tdp) (e.g., heart failure, hypokalemia, family history of long qt syndrome)
Item
2. patients with any of the following conditions: a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 ms), a history of additional risk factors for torsade de pointes (tdp) (e.g., heart failure, hypokalemia, family history of long qt syndrome)
boolean
C0040156 (UMLS CUI [1])
C0039236 (UMLS CUI [2])
C4478837 (UMLS CUI [3])
C0040479 (UMLS CUI [4,1])
C0035648 (UMLS CUI [4,2])
a history of myocardial infarction within 1 year of screening visit (visit 1), a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed), a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
Item
3. patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit (visit 1), a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed), a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
boolean
C0027051 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0034072 (UMLS CUI [3])
C0041296 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C0001883 (UMLS CUI [6,1])
C2826244 (UMLS CUI [6,2])
C0010674 (UMLS CUI [7])
C0006267 (UMLS CUI [8])
C0038586 (UMLS CUI [9])
thoracotomy with pulmonary resection
Item
4. patients who have undergone thoracotomy with pulmonary resection
boolean
C0039991 (UMLS CUI [1,1])
C0396565 (UMLS CUI [1,2])
investigational drug
Item
5. patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (visit 1)
boolean
C0013230 (UMLS CUI [1])
pregnancy or lactation
Item
6. pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
childbearing potential and contraception
Item
7. women of childbearing potential not using a highly effective method of birth control. female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least 2 years
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
participation status
Item
8. patients who have previously been randomized in this study or are currently participating in another study
boolean
C2348568 (UMLS CUI [1])
compliance
Item
9. patients who are unable to comply with pulmonary medication restrictions prior to randomization
boolean
C1321605 (UMLS CUI [1])
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