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To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in a specific sensitive to leukotriene population of asthma.
Hypothesis ：Monteluakst can better improve pre-challenge FEV1 from baseline in leukotriene-sensitive group than leukotriene-insensitive group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| montelukast，vitamin C pill | leukotriene receptor antagonist:(montelukast)，montelukast (10 mg, once per night)，56 days vitamin C pill:100mg，once per night，56 days | ||
| montelukast, vitamin C pill | montelukast:10 mg, once per night，56 days vitamin C pill:100mg，once per night，56 days |
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| Measure | Description | Time Frame |
|---|---|---|
| whether there was improvement in pre-challenge FEV1% | The primary outcome was a qualitative measure, with the results being expressed as either yes or no ('1' or '0' in Logistic model).A higher FEV1% is more suggestive of instability of asthma control. | from commencement of LTRA therapy to (7±2) days and (56±5) days |
| Measure | Description | Time Frame |
|---|---|---|
| whether there was improvement in post- treatment FENO | In Logistic regression model, whether there was improvement shown in post-treatment FENO as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure was qualitative one. FENO represented fractional exhaled nitric oxide above. | from commencement of LTRA therapy to (7±2) days and (56±5) days |
| Measure | Description | Time Frame |
|---|---|---|
| whether there was improvement in post- treatment PD20FEV1-MCH | In Logistic regression model, whether there was improvement shown in post-treatment PD20FEV1-MCH as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure above was qualitative. PD20FEV1-MCh referred to as the provocative dosage causing a 20% fall in FEV1 while using methacholine as a bronchoprovocant. |
Inclusion Criteria:
Exclusion Criteria:
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Bronchial Asthma patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shi Xu, doctor | Contact | +8618026250151 | shixu1003@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Institute of Respiratory Disease, State Key Laboratory of Respiratory Disease | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| from commencement of LTRA therapy to (7±2) days and (56±5) days |
| whether there was improvement in post- treatment AQLQ symptom score | In Logistic regression model, whether there was improvement shown in post-treatment AQLQ symptom score as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure above was qualitative. Items with regard to asthma symptoms were extracted from the whole AQLQ score, with the total score of 84. Higher score represented better asthma control. | from commencement of LTRA therapy to (7±2) days and (56±5) days |
| whether there was improvement in post- treatment ACT score | In Logistic regression model, whether there was improvement shown in post-treatment ACT score as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure above was qualitative. The total score of ACT was 25, with 5 questions in all. Higher score was indicative of better asthma control. | from commencement of LTRA therapy to (56±5) days |
| whether there was a gradual decrease in weekly use of salbutamol | In Logistic regression model, whether there was a gradual decrease in weekly use of salbutamol as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure was qualitative one. | from commencement of LTRA therapy to (56±5) days |
| improvement in weekly and monthly PEFR | The primary outcome was a qualitative measure, with the results being expressed as either yes or no ('1' or '0' in Logistic model).PEFR was defined as the changed rate of peak expiratory flow, which was calculated using the formula according to maximal PEF (PEFmax) and minimal PEF (PEFmin) measured by portable PEF monitor: 100%*(PEFmax-PEFmin)/[(PEFmax+PEFmin)*1/2]. A higher PEFR is more suggestive of instability of asthma control. | from commencement of LTRA therapy to (56±5) days |
| whether there was improvement in post- treatment PD20FEV1-LTD4 | In Logistic regression model, whether there was improvement shown in post-treatment PD20FEV1-LTD4 as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure above was qualitative. PD20FEV1-LTD4 referred to as the provocative dosage causing a 20% fall in FEV1 while using Leukotriene D4 as a bronchoprovocant. | from commencement of LTRA therapy to (7±2) days and (56±5) days |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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