Validity of Fractional Exhaled Nitric Oxide and Impulse Oscillometry in Patients With Cough Variant Asthma

July 26, 2021 updated by: Zhujiang Hospital

Evaluating the Efficacy of Fractional Exhaled Nitric Oxide and Impulse Oscillometry in Patients With Cough Variant Asthma

The aim of the research is to evaluate the clinical value of fractional exhaled nitric oxide(FeNO) ,impulse oscillometry(IOS) and mid-expiratory flow (MEF) in patients with cough variant asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study has the following objectives:

to evaluate the relationship between BHR and mid-expiratory flow, to assess the diagnostic accuracy of fractional exhaled nitric oxide，impulse oscillometry and mid-expiratory flow in CVA with special regard to its discriminating value between CVA and other causes of a chronic cough, to estimate prognostic value of BHR and fractional exhaled nitric oxide (FeNO) count in predicting response to asthma treatment.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

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
        • Huapeng Yu

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

age 18-65 years old. Cough as the sole or predominant symptom lasting for at least 8 weeks, with no radiographic evidence of lung diseases.

Exclusion Criteria:

treatment of any oral corticosteroid in the last 4 weeks, and respiratory tract infection within 8 weeks.

smoking (min. 6 months) had asthma or other lung diseases, including obliterative bronchiolitis, bronchiectasis,and cystic fibrosis.

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Asthma group
Patients with chronic nonproductive cough for more than 8 weeks based on physician's opinion will be subjected to FeNO, impulse oscillometry(IOS) and pulmonary function. Receiver operating characteristic (ROC) curves to evaluate the clinical value of FeNO and small airways indices in CVA diagnosis. The optimal cutoff point for the level of FeNO and IOS is also determined.
Diagnostic test: fractional exhaled nitric oxide(FeNO)
FeNO level was evaluated according to the American Thoracic Society (ATS)/ERS recommendations using a NIOX MINO analyzer (Aerocrine, Solna, Sweden) .Subjects were informed to deeply inhale NO-free air and immediately exhale in full via a mouthpiece at a constant flow rate (50 ml/s) for 10s.
Diagnostic test: impulse oscillometry(IOS)
The patient take seats, body relax, make sure the mouthpiece is fully covered by mouth, then clip nose with both hands to cover both sides of the cheek, and then calm breathing 1 minutes, the computer is automatically collected data calculation and print out the measurement results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the value of fractional exhaled nitric oxide(FeNO) in patients with cough variant asthma
Time Frame: at least 4 weeks of treatment
FENO will be performed by using a hand-held portable machine (NIOX MINO, Aerocrine AB, Solna, Sweden) at a standard flow rate of 50 mL/s, in accordance with ATS/ERS recommendations.
at least 4 weeks of treatment
the value of impulse oscillometry(IOS) in patients with cough variant asthma
Time Frame: at least 4 weeks of treatment
R5-R20（respiratory resistance）is measure by Jaeger MasterScreen Pulmonary
at least 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the value of forced mid-expiratory flow (MMEF) in patients with cough variant asthma
Time Frame: at least 4 weeks of treatment
MMEF will be performed with a spirometer (Jaeger, Hoechberg, Germany) in accordance with the specifications and performance criteria recommended in the American Thoracic Society (ATS)/European Respiratory Society (ERS) Standardization of Spirometry
at least 4 weeks of treatment
the value of BHR and fractional exhaled nitric oxide (FeNO) count in predicting response to asthma treatment
Time Frame: at least 4 weeks of treatment
MCH bronchial provocation tests will be performed with the Jaeger APS Pro system.Provocative dose causing a 20% fall in FEV1(PD20) will be recorded, and BHR is defined as present if PD20≤0.48 mg. FENO is measure by a hand-held portable machine(NIOX MINO, Aerocrine AB, Solna, Sweden)
at least 4 weeks of treatment
the relationship between BHR and mid-expiratory flow
Time Frame: at least 4 weeks of treatment
BHR is measure by Jaeger APS Pro system.MMEF will be performed with a spirometer (Jaeger, Hoechberg, Germany)
at least 4 weeks of treatment

Collaborators and Investigators

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

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Yu Hupeng, Southern Medical University, China

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 (ACTUAL)

August 12, 2018

Primary Completion (ACTUAL)

June 30, 2019

Study Completion (ACTUAL)

June 30, 2019

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (ACTUAL)

June 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-HXNK-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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