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

Cough Variant Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573284
• Other study ID #: 2018-HXNK-002
• Status: Completed
• Phase: N/A
• Start date: August 12, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2021
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Cough
• Cough Variant Asthma

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Huapeng Yu	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the value of fractional exhaled nitric oxide(FeNO) in patients with cough variant asthma	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
Primary	the value of impulse oscillometry(IOS) in patients with cough variant asthma	R5-R20(respiratory resistance)is measure by Jaeger MasterScreen Pulmonary	at least 4 weeks of treatment
Secondary	the value of forced mid-expiratory flow (MMEF) in patients with cough variant asthma	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
Secondary	the value of BHR and fractional exhaled nitric oxide (FeNO) count in predicting response to asthma 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
Secondary	the relationship between BHR and mid-expiratory flow	BHR is measure by Jaeger APS Pro system.MMEF will be performed with a spirometer (Jaeger, Hoechberg, Germany)	at least 4 weeks of treatment