Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics

NCT02574975 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-10-16

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Huizhen Fan, Doctor · Zhujiang Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02574975 on ClinicalTrials.gov