Comparison of Different Methodologies Assessing Airway Responsiveness and Investigation of Treatment Efficacy of Budesonide /Formoterol in Asthmatics
Overview
- Phase
- Phase 4
- Intervention
- methacholine
- Conditions
- Asthma
- Sponsor
- Zhujiang Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- positive rate of BPT in each group
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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 ）
Arms & Interventions
Methacholine diagnosing group
Methacholine bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System
Intervention: methacholine
Adenosine monophosphate diagnosing group
Adenosine monophosphate bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System
Intervention: adenosine monophosphate
Leukotriene D4 diagnosing group
Leukotriene D4 bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System
Intervention: leukotriene D4
Astograh diagnosing group
Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus
Intervention: Astograph Jupiter-21 airway reaction testing apparatus
budesonide /formoterol treatment group
budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three month
Intervention: budesonide /formoterol
Outcomes
Primary Outcomes
positive rate of BPT in each group
Time Frame: 3months
comparing positive rates of BPT in experimental groups and control group
Secondary Outcomes
- Fractional exhaled nitric oxide(FeNO)(3months)
- Forced expiratory volume at one second（FEV1）(3months)
- Provocative dosage causing a 20% fall in FEV1(PD20-FEV1)(3months)