Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Methacholine diagnosing group

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

Group Type ACTIVE_COMPARATOR

methacholine

Intervention Type DRUG

Methacholine,inhaled cumulative dosage 2.5mg

Adenosine monophosphate diagnosing group

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

Group Type EXPERIMENTAL

adenosine monophosphate

Intervention Type DRUG

Adenosine monophosphate ,inhaled cumulative dosage 40mg

Leukotriene D4 diagnosing group

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

Group Type EXPERIMENTAL

leukotriene D4

Intervention Type DRUG

Leukotriene D4,inhaled cumulative dosage 2.4 μg

Astograh diagnosing group

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

Group Type EXPERIMENTAL

Astograph Jupiter-21 airway reaction testing apparatus

Intervention Type DEVICE

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

budesonide /formoterol treatment group

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

Group Type EXPERIMENTAL

budesonide /formoterol

Intervention Type DRUG

budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three months in all participants (80 Anticipated)

Interventions

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methacholine

Methacholine,inhaled cumulative dosage 2.5mg

Intervention Type DRUG

adenosine monophosphate

Adenosine monophosphate ,inhaled cumulative dosage 40mg

Intervention Type DRUG

leukotriene D4

Leukotriene D4,inhaled cumulative dosage 2.4 μg

Intervention Type DRUG

Astograph Jupiter-21 airway reaction testing apparatus

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

Intervention Type DEVICE

budesonide /formoterol

budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three months in all participants (80 Anticipated)

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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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 ）

Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No