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

NCT ID: NCT01340118

Last Updated: 2011-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-07-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Budesonide

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.

Group Type: EXPERIMENTAL

Budesonide

Intervention Type: DRUG

once daily inhalation with 400 µg budesonide (dry powder)during 6 weeks

remain untreated

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Budesonide

once daily inhalation with 400 µg budesonide (dry powder)during 6 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chungbuk National University

OTHER

Sponsor Role: lead

Responsible Party

Department of pediatics,Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju, Korea,

Principal Investigators

Youn-Soo Hahn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju

Locations

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Countries

South Korea

Other Identifiers

WC asthma treatment based FeNO

Identifier Type: -

Identifier Source: org_study_id