Back to resultsValidity of Fractional Exhaled Nitric Oxide and Impulse Oscillometry in Patients With Cough Variant Asthma
Primary Purpose
Cough Variant Asthma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
fractional exhaled nitric oxide(FeNO)
impulse oscillometry(IOS)
Sponsored by
About this trial
This is an interventional diagnostic trial for Cough Variant Asthma focused on measuring cough variant asthma, chronic cough, fractional exhaled nitric oxide, impulse oscillometry, forced mid-expiratory flow
Eligibility 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.
Sites / Locations
- Huapeng Yu
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Asthma group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
the value of impulse oscillometry(IOS) in patients with cough variant asthma
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
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
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
BHR is measure by Jaeger APS Pro system.MMEF will be performed with a spirometer (Jaeger, Hoechberg, Germany)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03573284
Brief Title
Validity of Fractional Exhaled Nitric Oxide and Impulse Oscillometry in Patients With Cough Variant Asthma
Official Title
Evaluating the Efficacy of Fractional Exhaled Nitric Oxide and Impulse Oscillometry in Patients With Cough Variant Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 12, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough Variant Asthma
Keywords
cough variant asthma, chronic cough, fractional exhaled nitric oxide, impulse oscillometry, forced mid-expiratory flow
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asthma group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
fractional exhaled nitric oxide(FeNO)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
impulse oscillometry(IOS)
Intervention Description
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 Measure Information:
Title
the value of fractional exhaled nitric oxide(FeNO) in patients with cough variant asthma
Description
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.
Time Frame
at least 4 weeks of treatment
Title
the value of impulse oscillometry(IOS) in patients with cough variant asthma
Description
R5-R20（respiratory resistance）is measure by Jaeger MasterScreen Pulmonary
Time Frame
at least 4 weeks of treatment
Secondary Outcome Measure Information:
Title
the value of forced mid-expiratory flow (MMEF) in patients with cough variant asthma
Description
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
Time Frame
at least 4 weeks of treatment
Title
the value of BHR and fractional exhaled nitric oxide (FeNO) count in predicting response to asthma treatment
Description
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)
Time Frame
at least 4 weeks of treatment
Title
the relationship between BHR and mid-expiratory flow
Description
BHR is measure by Jaeger APS Pro system.MMEF will be performed with a spirometer (Jaeger, Hoechberg, Germany)
Time Frame
at least 4 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Hupeng
Organizational Affiliation
Southern Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huapeng Yu
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Validity of Fractional Exhaled Nitric Oxide and Impulse Oscillometry in Patients With Cough Variant Asthma
We'll reach out to this number within 24 hrs