Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics

Phase 4

Interventions: Device: Astograph Jupiter-21 airway reaction testing apparatus
Drug: budesonide /formoterol
Drug: methacholine
Drug: leukotriene D4
Drug: adenosine monophosphate

Brief Summary: Bronchial asthma is a common chronic respiratory disease. Patients usually manifest variable symptoms (such as short of breath, chest tightness, cough, etc.) and variable airflow limitation and often associated with airway hyper-responsiveness and airway inflammation. About 1-18% of the global population suffered from the disease, causing huge economic burden for patients and countries. Airway reactivity measurement is an important way of diagnosis of asthma. Methacholine (Mch) bronchial provocation test(BPT) is the "gold standard" for the determination of airway reactivity, and other measuring methods(like adenosine monophosphate(AMP)-BPT, leukotriene D4(LTD4)-BPT, Astograph-BPT, etc.) were also brought into hot research fields. The investigators' purposes were to compare different kinds of methodologies(Mch,AMP,LTD4-BPT, Astograph-BPT) assessing airway responsiveness and to investigate treatment efficacy of budesonide /formoterol in asthmatics.

Detailed Description: This study composed of two parts, that were the diagnosing part and the treatment part.

Recruitment & Eligibility

Inclusion Criteria

Clinically diagnosed Asthmatic patients aged from14 to 65 years；
Had a had a normal chest radiographic result；
Had a baseline spirometry with the forced expiratory volume in one second (FEV1) of not less than 60% predicted；
Without acute upper respiratory tract infection for the past 2 weeks

Exclusion Criteria

Smokers；
Had a poor cooperation to the test or limited understandings;
Had a past confirmed history of respiratory disease other than bronchial asthma (COPD, bronchiectasis, pulmonary thromboembolism, etc.) or other severe systemic disease（myocardial infarction, malignant tumor, etc.）;
Pregnancy or breast-feeding women;
Taken related drugs before measurements（Leukotriene receptor antagonists (LTRA) for 5 days，oral glucocorticosteroid or anti-histamine for 3 days，oral xanthenes or long-acting bronchodilators for 2 days，inhaled corticosteroid or long-acting bronchodilator for a day , short-acting bronchodilator for 4 hours ）

Arm && Interventions

Group	Intervention	Description
Astograh diagnosing group	Astograph Jupiter-21 airway reaction testing apparatus	Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus
budesonide /formoterol treatment group	budesonide /formoterol	budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three month
Methacholine diagnosing group	methacholine	Methacholine bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System
Leukotriene D4 diagnosing group	leukotriene D4	Leukotriene D4 bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System
Adenosine monophosphate diagnosing group	adenosine monophosphate	Adenosine monophosphate bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System

Primary Outcome Measures

Name	Time	Method
positive rate of BPT in each group	3months	comparing positive rates of BPT in experimental groups and control group

Secondary Outcome Measures

Name	Time	Method
Fractional exhaled nitric oxide(FeNO)	3months	change of FeNO at one month interval for 3 consecutive months
Forced expiratory volume at one second（FEV1）	3months	change of FEV1 measured by pulmonary function test（PFT）at one month interval for 3 consecutive months
Provocative dosage causing a 20% fall in FEV1(PD20-FEV1)	3months	change of PD20-FEV1 at one month interval for 3 consecutive months in each group

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