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Improvement of FeNO and FEF25-75 After Inhaled Corticosteroid Treatment of Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Budesonide
Sponsored by
Chungbuk National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, FEF25-75, exhaled nitric oxide, inhaled corticosteroid, children

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • sensitized to aeroallergens and previously diagnosed to have asthma based on the documentation of airway hyperresponsiveness (methacholine PC20 ≤ 8 mg/mL) and/or reversible airflow obstruction (≥ 12% improvement in FEV1 in response to inhaled beta 2-agonist)
  • maintained asthma control without controller medication for 3 months or more
  • FeNO > 25 ppb

Exclusion Criteria:

  • who had significant pulmonary disease other than asthma or a history of gastroesophageal reflux

Sites / Locations

  • Chungbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Budesonide

remain untreated

Arm Description

Patients with FeNO level greater than 25 ppb were randomly allocated to one of two groups. Randomisation was stratified by baseline FeNO. In one group (treatment group), participants were assigned to once daily treatment with 400 µg budesonide. In the other group (non-treatment group), participants did not receive any medication.

Outcomes

Primary Outcome Measures

FeNO
FeNO was measured at week 6 in the treatment and non-treatment groups.

Secondary Outcome Measures

Spirometric values(FEF25-75,FEV1,FEV1/FVC)
Spirometric values were evaluated at week 6 in the treatment and non-treatment groups.
Asthma control test scores
Asthma control test scores were evaluated at week 6 in the treatment and non-treatment groups.

Full Information

First Posted
April 15, 2011
Last Updated
April 20, 2011
Sponsor
Chungbuk National University
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1. Study Identification

Unique Protocol Identification Number
NCT01340118
Brief Title
Improvement of FeNO and FEF25-75 After Inhaled Corticosteroid Treatment of Asthma
Official Title
Concurrent Improvement of Exhaled Nitric Oxide and FEF25-75 After Treatment With Inhaled Corticosteroid in Children With Controlled Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chungbuk National University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Abnormal lung function and high exhaled nitric oxide (FeNO) have been reported in asymptomatic patients with asthma. The investigators aimed to assess whether FeNO and FEF25-75 improve concurrently after treatment with inhaled corticosteroid (ICS) in patients with controlled asthma. Geometric mean (GM) FeNO and spirometric values in patients 8 to 16 years of age who maintained asthma control without controller medication were compared with healthy controls and patients with uncontrolled asthma who were also not receiving controller medications. Patients with controlled asthma and high FeNO (> 25 ppb) were randomized to ICS treatment or to remain untreated. Changes in spirometric values and GM FeNO from baseline were evaluated after 6 weeks.
Detailed Description
Current guideline-defined asthma control cannot be applied to the level of airway inflammation because neither symptoms nor the results of basic pulmonary function tests can reflect ongoing airway inflammation.Consequently, asymptomatic or minimally symptomatic patients are usually considered to have controlled asthma even if they have subclinical airway inflammation. Measures of airway inflammation are thus required to identify patients with silent airway inflammation which does not manifest itself as symptoms or impaired lung function. In addition, measurement should be easy to perform, reproducible, and associated with a high degree of acceptance by patients. In this regard, the advent of FeNO measurements represents a significant advance in monitoring airway inflammation of asthmatic patients. High FeNO values above certain cut-point may indicate active eosinophilic airway inflammation and the likelihood of deterioration in asthma control. However, it is still unclear that high FeNO in asymptomatic patients implies the need for the anti-inflammatory treatment. Current guidelines for asthma management recommended forced expiratory volume in the first second (FEV1) as a principle spirometric parameter to assess airflow limitation. However, asthmatic subjects have air trapping in the presence of normal FEV1. Air trapping in asthmatic subjects has been demonstrated to be better correlated with forced expiratory flow between 25% and 75% of vital capacity % predicted (FEF25-75 % predicted) than FEV1 % predicted. In fact, impaired FEF25-75 is one of the most common abnormalities in pulmonary function in cross-sectional studies in asymptomatic patients. In addition, high FeNO in asymptomatic or minimally symptomatic patients may be accompanied by impairment of FEF25-75 because both parameters have been suggested to be measures of residual small airway disease. Therefore, there is a possibility that the improvement of FEF25-75 happens concomitantly with the decrease of FeNO during the anti-inflammatory treatment. In this study, we recruited previously well-documented atopic asthmatic children who required no medication to maintain asthma control for more than 3 months and had high FeNO levels (> 25 ppb). We aimed to assess whether the decrease of FeNO occurs simultaneously with improvement of FEF25-75 after treatment with inhaled corticosteroid (ICS) in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, FEF25-75, exhaled nitric oxide, inhaled corticosteroid, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Budesonide
Arm Type
Experimental
Arm Description
Patients with FeNO level greater than 25 ppb were randomly allocated to one of two groups. Randomisation was stratified by baseline FeNO. In one group (treatment group), participants were assigned to once daily treatment with 400 µg budesonide. In the other group (non-treatment group), participants did not receive any medication.
Arm Title
remain untreated
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
once daily inhalation with 400 µg budesonide (dry powder)during 6 weeks
Primary Outcome Measure Information:
Title
FeNO
Description
FeNO was measured at week 6 in the treatment and non-treatment groups.
Time Frame
6 weeks after enrollment
Secondary Outcome Measure Information:
Title
Spirometric values(FEF25-75,FEV1,FEV1/FVC)
Description
Spirometric values were evaluated at week 6 in the treatment and non-treatment groups.
Time Frame
6 weeks
Title
Asthma control test scores
Description
Asthma control test scores were evaluated at week 6 in the treatment and non-treatment groups.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: sensitized to aeroallergens and previously diagnosed to have asthma based on the documentation of airway hyperresponsiveness (methacholine PC20 ≤ 8 mg/mL) and/or reversible airflow obstruction (≥ 12% improvement in FEV1 in response to inhaled beta 2-agonist) maintained asthma control without controller medication for 3 months or more FeNO > 25 ppb Exclusion Criteria: who had significant pulmonary disease other than asthma or a history of gastroesophageal reflux
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youn-Soo Hahn, MD, PhD
Organizational Affiliation
Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju
State/Province
Chungbuk
ZIP/Postal Code
361-711
Country
Korea, Republic of

12. IPD Sharing Statement

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Improvement of FeNO and FEF25-75 After Inhaled Corticosteroid Treatment of Asthma

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