Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics
Comparison of Different Methodologies Assessing Airway Responsiveness and Investigation of Treatment Efficacy of Budesonide /Formoterol in Asthmatics
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 asthma
Started Apr 2015
Shorter than P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 8, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedOctober 16, 2015
October 1, 2015
1.1 years
October 8, 2015
October 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
positive rate of BPT in each group
comparing positive rates of BPT in experimental groups and control group
3months
Secondary Outcomes (3)
Forced expiratory volume at one second（FEV1）
3months
Fractional exhaled nitric oxide(FeNO)
3months
Provocative dosage causing a 20% fall in FEV1(PD20-FEV1)
3months
Study Arms (5)
Methacholine diagnosing group
ACTIVE COMPARATORMethacholine bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System
Adenosine monophosphate diagnosing group
EXPERIMENTALAdenosine monophosphate bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System
Leukotriene D4 diagnosing group
EXPERIMENTALLeukotriene D4 bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System
Astograh diagnosing group
EXPERIMENTALMethacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus
budesonide /formoterol treatment group
EXPERIMENTALbudesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three month
Interventions
Adenosine monophosphate ,inhaled cumulative dosage 40mg
Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus
budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three months in all participants (80 Anticipated)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 ）
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhujiang Hospital
Guangzhou, Guangdong, 510280, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huizhen Fan, Doctor
Zhujiang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2015
First Posted
October 14, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
October 16, 2015
Record last verified: 2015-10