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NCT Number: NCT03573284

Validity 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.

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Key information

Conditions

Cough Variant Asthma Asthma Bronchial Diseases Chronic Cough Cough Cough-Variant Asthma Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huapeng Yu

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fractional exhaled nitric oxide(FeNO)

Diagnostic Test

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)

Diagnostic Test

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2018
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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