Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics
NCT02574975 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2015-10-16
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.
Conditions
Interventions
- DRUG
-
methacholine
Methacholine,inhaled cumulative dosage 2.5mg
- DRUG
-
adenosine monophosphate
Adenosine monophosphate ,inhaled cumulative dosage 40mg
- DRUG
-
leukotriene D4
Leukotriene D4,inhaled cumulative dosage 2.4 μg
- DEVICE
-
Astograph Jupiter-21 airway reaction testing apparatus
Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus
- DRUG
-
budesonide /formoterol
budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three months in all participants (80 Anticipated)
Sponsors & Collaborators
-
Zhujiang Hospital
lead OTHER
Principal Investigators
-
Huizhen Fan, Doctor · Zhujiang Hospital
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-04-30
- Primary Completion
- 2016-05-31
- Completion
- 2016-05-31
Countries
- China
Study Locations
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