Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02574975
• Other study ID #: ZhujiangH
• Status: Recruiting
• Phase: Phase 4
• First received: October 8, 2015
• Last updated: October 15, 2015
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: October 2015
• Source: Zhujiang Hospital
• Contact: Shuhan Wu, Master
• Phone: 13268268627
• Email: 664397041[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

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 )

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• methacholine
Methacholine,inhaled cumulative dosage 2.5mg
• adenosine monophosphate
Adenosine monophosphate ,inhaled cumulative dosage 40mg
• leukotriene D4
Leukotriene D4,inhaled cumulative dosage 2.4 µg

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

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

Locations

Country	Name	City	State
China	Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive rate of BPT in each group	comparing positive rates of BPT in experimental groups and control group	3months	Yes
Secondary	Forced expiratory volume at one second(FEV1)	change of FEV1 measured by pulmonary function test(PFT)at one month interval for 3 consecutive months	3months	Yes
Secondary	Fractional exhaled nitric oxide(FeNO)	change of FeNO at one month interval for 3 consecutive months	3months	Yes
Secondary	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	3months	Yes