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

NCT01340118 | Completed Phase 4

• 1 other identifier: WC asthma treatment based FeNO
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; FEF25-75; exhaled nitric oxide; inhaled corticosteroid; children

Outcome Measures

Primary Outcomes (1)

• FeNO

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

  6 weeks after enrollment

Secondary Outcomes (2)

• Spirometric values(FEF25-75,FEV1,FEV1/FVC)

  6 weeks

• Asthma control test scores

  6 weeks

Study Arms (2)

Budesonide

EXPERIMENTAL

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.

Drug: Budesonide

remain untreated

NO INTERVENTION

Interventions

Budesonide DRUG

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

Budesonide

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chungbuk National University: lead

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 361-711, South Korea

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Youn-Soo Hahn, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 22, 2011
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 22, 2011

Record last verified: 2011-04

Locations

KR (1)