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

NCT03573284 | Completed

• 1 other identifier: 2018-HXNK-002
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough Variant Asthma

Keywords

cough variant asthma; chronic cough; fractional exhaled nitric oxide; impulse oscillometry; forced mid-expiratory flow

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• the value of forced mid-expiratory flow (MMEF) in patients with cough variant asthma

  at least 4 weeks of treatment

• the value of BHR and fractional exhaled nitric oxide (FeNO) count in predicting response to asthma treatment

  at least 4 weeks of treatment

• the relationship between BHR and mid-expiratory flow

  at least 4 weeks of treatment

Study Arms (1)

Asthma group

EXPERIMENTAL

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); Diagnostic Test: impulse oscillometry(IOS)

Interventions

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.

Asthma group

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.

Asthma group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Huapeng Yu

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Cough-Variant Asthma; Chronic Cough

Interventions

Fractional Exhaled Nitric Oxide Testing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Breath Tests; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yu Hupeng

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 29, 2018
• Study Start: August 12, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

CN (1)