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

NCT01340118 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2011-04-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Budesonide

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

Sponsors & Collaborators

  • Chungbuk National University

    lead OTHER

Principal Investigators

  • Youn-Soo Hahn, MD, PhD · Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01340118 on ClinicalTrials.gov