Clinical trial NCT02574975: Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics
Official title: Comparison of Different Methodologies Assessing Airway Responsiveness and Investigation of Treatment Efficacy of Budesonide /Formoterol in Asthmatics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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:

* 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 ）

Primary outcomes:
measure: positive rate of BPT in each group
timeFrame: 3months
Secondary outcomes:
measure: Forced expiratory volume at one second（FEV1）
timeFrame: 3months
measure: Fractional exhaled nitric oxide(FeNO)
timeFrame: 3months
measure: Provocative dosage causing a 20% fall in FEV1(PD20-FEV1)
timeFrame: 3months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Huizhen Fan, Doctor
role: STUDY_CHAIR
References: