Asthma
Conditions
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.
Interventions
DRUGmethacholine
Methacholine,inhaled cumulative dosage 2.5mg
Adenosine monophosphate ,inhaled cumulative dosage 40mg
DRUGleukotriene D4
Leukotriene D4,inhaled cumulative dosage 2.4 μg
DEVICEAstograph Jupiter-21 airway reaction testing apparatus
Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus
DRUGbudesonide /formoterol
budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three months in all participants (80 Anticipated)
Sponsors
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
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 ）
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| positive rate of BPT in each group | 3months | comparing positive rates of BPT in experimental groups and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Fractional exhaled nitric oxide(FeNO) | 3months | change of FeNO 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 |
Countries
China
Contacts
Primary ContactShuhan Wu, Master
Outcome results
None listed