ID

13559

Description

Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01404013

Link

https://clinicaltrials.gov/show/NCT01404013

Keywords

Versions (1)
  1. 2/15/16 2/15/16 -
Uploaded on

February 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT01404013

English

Eligibility Asthma NCT01404013

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01404013
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
Description

medical history Coughing

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0010200
2. patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
Description

Inhalation bronchial challenge testing with methacholine

Data type

boolean

Alias
UMLS CUI [1]
C3526951
3. there is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least).
Description

therapy Bronchodilator Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0006280
4. patients whose chest x-ray outcome was normal or without any active focus.
Description

chest x-ray

Data type

boolean

Alias
UMLS CUI [1]
C0039985
5. patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients demonstrate fev1/fvc ＜70% in lung function test. fev1 stands for forced expiratory volume in 1 second, fvc stands for forced vital capacity.
Description

FEV1/FVC percent

Data type

boolean

Alias
UMLS CUI [1]
C0730560
2. patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history ＞10 pack-years or equivalence.
Description

Smoking Status

Data type

boolean

Alias
UMLS CUI [1]
C1519386
3. patients with concomitance of gerc (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, acei induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
Description

comorbidity; chronic bronchitis

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0008677
4. female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
Description

pregnancy; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
Description

hypersensitivity drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
6. subjects who have received any therapy in the previous seven days, e.g. oral/
Description

Concomitant Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1707479
inhaled/systematic corticosteroid, long-acting β2 agonist, theophylline sustained release.
Description

corticosteroid; Adrenergic beta-2 Receptor Agonists;

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C2936789
UMLS CUI [3]
C0039771
7. subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia.
Description

study outcome limited comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0543472
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
8. subjects who demonstrate significant abnormality on biochemistry, hematology, ecg.
Description

biochemistry; hematology; Electrocardiogram

Data type

boolean

Alias
UMLS CUI [1]
C0005477
UMLS CUI [2]
C0018941
UMLS CUI [3]
C0013798
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Similar models

Eligibility Asthma NCT01404013

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01404013
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
medical history Coughing
Item
1. patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
boolean
C0262926 (UMLS CUI [1,1])
C0010200 (UMLS CUI [1,2])
Inhalation bronchial challenge testing with methacholine
Item
2. patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
boolean
C3526951 (UMLS CUI [1])
therapy Bronchodilator Agents
Item
3. there is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least).
boolean
C0087111 (UMLS CUI [1,1])
C0006280 (UMLS CUI [1,2])
chest x-ray
Item
4. patients whose chest x-ray outcome was normal or without any active focus.
boolean
C0039985 (UMLS CUI [1])
age
Item
5. patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
FEV1/FVC percent
Item
1. patients demonstrate fev1/fvc ＜70% in lung function test. fev1 stands for forced expiratory volume in 1 second, fvc stands for forced vital capacity.
boolean
C0730560 (UMLS CUI [1])
Smoking Status
Item
2. patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history ＞10 pack-years or equivalence.
boolean
C1519386 (UMLS CUI [1])
comorbidity; chronic bronchitis
Item
3. patients with concomitance of gerc (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, acei induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
boolean
C0009488 (UMLS CUI [1])
C0008677 (UMLS CUI [2])
pregnancy; lactating
Item
4. female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hypersensitivity drugs
Item
5. subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant Therapy
Item
6. subjects who have received any therapy in the previous seven days, e.g. oral/
boolean
C1707479 (UMLS CUI [1])
corticosteroid; Adrenergic beta-2 Receptor Agonists;
Item
inhaled/systematic corticosteroid, long-acting β2 agonist, theophylline sustained release.
boolean
C0001617 (UMLS CUI [1])
C2936789 (UMLS CUI [2])
C0039771 (UMLS CUI [3])
study outcome limited comorbidity
Item
7. subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia.
boolean
C0543472 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
biochemistry; hematology; Electrocardiogram
Item
8. subjects who demonstrate significant abnormality on biochemistry, hematology, ecg.
boolean
C0005477 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
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