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
|Condition or disease||Intervention/treatment||Phase|
|Cough Variant Asthma||Diagnostic Test: fractional exhaled nitric oxide(FeNO) Diagnostic Test: impulse oscillometry(IOS)||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
- 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
- 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)
- 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)
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
|Contact: Yu Huapeng||+86 email@example.com|
|Guangzhou, Guangdong, China|
|Contact: Yu Huapeng +86 020-61643888 firstname.lastname@example.org|
|Principal Investigator:||Yu Hupeng||Southern Medical University, China|