Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics

Zhujiang Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

Eligibility

Sex: ALLMin age: 14 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 ）

Outcomes

Primary Outcomes

positive rate of BPT in each group

comparing positive rates of BPT in experimental groups and control group

Time frame: 3months

Secondary Outcomes

Forced expiratory volume at one second（FEV1）

change of FEV1 measured by pulmonary function test（PFT）at one month interval for 3 consecutive months

Time frame: 3months

Fractional exhaled nitric oxide(FeNO)

change of FeNO at one month interval for 3 consecutive months

Time frame: 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

Time frame: 3months

Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts