Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics

Sponsor

Zhujiang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02574975

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: methacholine Drug: adenosine monophosphate Drug: leukotriene D4 Device: Astograph Jupiter-21 airway reaction testing apparatus Drug: budesonide /formoterol	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Comparison of Different Methodologies Assessing Airway Responsiveness and Investigation of Treatment Efficacy of Budesonide /Formoterol in Asthmatics

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

May 1, 2016

Anticipated Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Methacholine diagnosing group Methacholine bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System	Drug: methacholine Methacholine,inhaled cumulative dosage 2.5mg
Experimental: Adenosine monophosphate diagnosing group Adenosine monophosphate bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System	Drug: adenosine monophosphate Adenosine monophosphate ,inhaled cumulative dosage 40mg
Experimental: Leukotriene D4 diagnosing group Leukotriene D4 bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System	Drug: leukotriene D4 Leukotriene D4,inhaled cumulative dosage 2.4 μg
Experimental: Astograh diagnosing group Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus	Device: Astograph Jupiter-21 airway reaction testing apparatus Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus
Experimental: budesonide /formoterol treatment group budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three month	Drug: budesonide /formoterol budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three months in all participants (80 Anticipated) Other Names: Symbicort

Outcome Measures

Primary Outcome Measures

positive rate of BPT in each group [3months]
comparing positive rates of BPT in experimental groups and control group

Secondary Outcome Measures

Forced expiratory volume at one second（FEV1） [3months]
change of FEV1 measured by pulmonary function test（PFT）at one month interval for 3 consecutive months
Fractional exhaled nitric oxide(FeNO) [3months]
change of FeNO at one month interval for 3 consecutive months
Provocative dosage causing a 20% fall in FEV1(PD20-FEV1) [3months]
change of PD20-FEV1 at one month interval for 3 consecutive months in each group

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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 ）

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhujiang Hospital	Guangzhou	Guangdong	China	510280

Sponsors and Collaborators

Zhujiang Hospital

Investigators

Study Chair: Huizhen Fan, Doctor, Zhujiang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhujiang Hospital

ClinicalTrials.gov Identifier:

NCT02574975

Other Study ID Numbers:

ZhujiangH

First Posted:

Oct 14, 2015

Last Update Posted:

Oct 16, 2015

Last Verified:

Oct 1, 2015

Additional relevant MeSH terms:

Methacholine Chloride

Study Results

No Results Posted as of Oct 16, 2015