Eligibility Asthma NCT01404013

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StudyEvent: Eligibility
1. Eligibility Asthma NCT01404013

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Asthma NCT01404013