Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics

Zhujiang Hospital

Status and phase: Unknown; Phase 4

Conditions: Asthma

Treatments: Drug: budesonide /formoterol; Device: Astograph Jupiter-21 airway reaction testing apparatus; Drug: adenosine monophosphate; Drug: leukotriene D4; Drug: methacholine

Study type: Interventional

Funder types: Other

Identifiers

NCT02574975

ZhujiangH

Details and patient eligibility

About

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.

Full description

This study composed of two parts, that were the diagnosing part and the treatment part.

Enrollment: 80 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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 ）

Trial design

80 participants in 5 patient groups

Methacholine diagnosing group

Active Comparator group

Description:

Methacholine bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System

Treatment:

Drug: methacholine

Adenosine monophosphate diagnosing group

Experimental group

Description:

Adenosine monophosphate bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System

Treatment:

Drug: adenosine monophosphate

Leukotriene D4 diagnosing group

Experimental group

Description:

Leukotriene D4 bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System

Treatment:

Drug: leukotriene D4

Astograh diagnosing group

Experimental group

Description:

Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus

Treatment:

Device: Astograph Jupiter-21 airway reaction testing apparatus

budesonide /formoterol treatment group

Experimental group

Description:

budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three month

Treatment:

Drug: budesonide /formoterol