Eligibility Asthma NCT00467740

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StudyEvent: Eligibility
1. Eligibility Asthma NCT00467740

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Inclusion Criteria

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])

Exclusion Criteria

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])
C4013561 (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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Eligibility Asthma NCT00467740