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

Asthma Clinical Trial

Official title:

Concurrent Improvement of Exhaled Nitric Oxide and FEF25-75 After Treatment With Inhaled Corticosteroid in Children With Controlled Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340118
• Other study ID #: WC asthma treatment based FeNO
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2011
• Last updated: April 20, 2011
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: April 2011
• Source: Chungbuk National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide
once daily inhalation with 400 µg budesonide (dry powder)during 6 weeks

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheongju	Chungbuk

Sponsors (1)

Lead Sponsor	Collaborator
Chungbuk National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FeNO	FeNO was measured at week 6 in the treatment and non-treatment groups.	6 weeks after enrollment	No
Secondary	Spirometric values(FEF25-75,FEV1,FEV1/FVC)	Spirometric values were evaluated at week 6 in the treatment and non-treatment groups.	6 weeks	No
Secondary	Asthma control test scores	Asthma control test scores were evaluated at week 6 in the treatment and non-treatment groups.	6 weeks	No