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

Sponsor

Zhujiang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03573284

Collaborator

(none)

146

Enrollment

Location

Arm

10.6

Actual Duration (Months)

13.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cough Variant Asthma	Diagnostic Test: fractional exhaled nitric oxide(FeNO) Diagnostic Test: impulse oscillometry(IOS)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

146 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 12, 2018

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

the value of fractional exhaled nitric oxide(FeNO) in patients with cough variant asthma [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.
the value of impulse oscillometry(IOS) in patients with cough variant asthma [at least 4 weeks of treatment]
R5-R20（respiratory resistance）is measure by Jaeger MasterScreen Pulmonary

Secondary Outcome Measures

the value of forced mid-expiratory flow (MMEF) in patients with cough variant asthma [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
the value of BHR and fractional exhaled nitric oxide (FeNO) count in predicting response to asthma treatment [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)
the relationship between BHR and mid-expiratory flow [at least 4 weeks of treatment]
BHR is measure by Jaeger APS Pro system.MMEF will be performed with a spirometer (Jaeger, Hoechberg, Germany)