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

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ClinicalTrials.gov Identifier: NCT03573284
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Zhujiang Hospital

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) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
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 : August 12, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Cough

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573284


Contacts
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Contact: Yu Huapeng +86 020-61643888 359606545@qq.com

Locations
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China, Guangdong
Huapeng Yu Recruiting
Guangzhou, Guangdong, China
Contact: Yu Huapeng    +86 020-61643888    359606545@qq.com   
Sponsors and Collaborators
Zhujiang Hospital
Investigators
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Principal Investigator: Yu Hupeng Southern Medical University, China

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Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT03573284     History of Changes
Other Study ID Numbers: 2018-HXNK-002
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhujiang Hospital:
cough variant asthma
chronic cough
fractional exhaled nitric oxide
impulse oscillometry
forced mid-expiratory flow

Additional relevant MeSH terms:
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Asthma
Anti-Asthmatic Agents
Cough
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents