drugset / Trial / NCT02574975

Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics

NCT02574975

Phase 4 Unknown 80 enrolled Zhujiang Hospital
RandomizedParallel-groupOpen-label

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.

Timeline

Start
2015-04
Primary completion
2016-05
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Adenosine Monophosphate Unknown 40 mg Inhaled
Subject Budesonide Small molecule 160 ug Inhaled
Subject Formoterol Other / unclassified 4.5 ug Inhaled
Comparator Methacholine Diagnostic / imaging agent 2.5 mg Inhaled
Subject leukotriene D4 Small molecule 2.4 ug Inhaled

Indications