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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.
This study composed of two parts, that were the diagnosing part and the treatment part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methacholine diagnosing group | Active Comparator | Methacholine bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System |
|
| Adenosine monophosphate diagnosing group | Experimental | Adenosine monophosphate bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System |
|
| Leukotriene D4 diagnosing group | Experimental | Leukotriene D4 bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System |
|
| Astograh diagnosing group | Experimental | Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus |
|
| budesonide /formoterol treatment group | Experimental | budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methacholine | Drug | Methacholine,inhaled cumulative dosage 2.5mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| positive rate of BPT in each group | comparing positive rates of BPT in experimental groups and control group | 3months |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume at one second(FEV1) | change of FEV1 measured by pulmonary function test(PFT)at one month interval for 3 consecutive months | 3months |
| Fractional exhaled nitric oxide(FeNO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuhan Wu, Master | Contact | 13268268627 | 664397041@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Huizhen Fan, Doctor | Zhujiang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital | Recruiting | Guangzhou | Guangdong | 510280 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D016210 | Methacholine Chloride |
| D000249 | Adenosine Monophosphate |
| D017998 | Leukotriene D4 |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D008688 | Methacholine Compounds |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| adenosine monophosphate |
| Drug |
Adenosine monophosphate ,inhaled cumulative dosage 40mg |
|
| leukotriene D4 | Drug | Leukotriene D4,inhaled cumulative dosage 2.4 μg |
|
| Astograph Jupiter-21 airway reaction testing apparatus | Device | Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus |
|
| budesonide /formoterol | Drug | budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three months in all participants (80 Anticipated) |
|
|
change of FeNO at one month interval for 3 consecutive months
| 3months |
| Provocative dosage causing a 20% fall in FEV1(PD20-FEV1) | change of PD20-FEV1 at one month interval for 3 consecutive months in each group | 3months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D013189 | SRS-A |
| D015289 | Leukotrienes |
| D001095 | Arachidonic Acids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005228 | Fatty Acids, Essential |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |