Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics

October 15, 2015 updated by: Zhujiang Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • Zhujiang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive rate of BPT in each group
Time Frame: 3months
comparing positive rates of BPT in experimental groups and control group
3months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Study Chair: Huizhen Fan, Doctor, Zhujiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhujiangH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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