NCT02574975

Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	methacholine	Methacholine,inhaled cumulative dosage 2.5mg
DRUG	adenosine monophosphate	Adenosine monophosphate ,inhaled cumulative dosage 40mg
DRUG	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)

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-10-14
• Last updated: 2015-10-16

Locations

1 site across 1 country: China