AsthmaPhase 4NCT01340118
Improvement of FeNO and FEF25-75 After Inhaled Corticosteroid Treatment of Asthma
A Phase 4 study testing Budesonide in people with Asthma, run by Chungbuk National University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- who had significant pulmonary disease other than asthma or a history of gastroesophageal reflux
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 361-711
About this study
Official title: Concurrent Improvement of Exhaled Nitric Oxide and FEF25-75 After Treatment With Inhaled Corticosteroid in Children With Controlled Asthma
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.
Read the 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
- Being tested
- Budesonide
- Keywords
- Asthma, FEF25-75, exhaled nitric oxide, inhaled corticosteroid, children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
once daily inhalation with 400 µg budesonide (dry powder)during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Budesonide |
| remain untreated | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
FeNO
FeNO was measured at week 6 in the treatment and non-treatment groups.
Measured: 6 weeks after enrollment
Secondary outcomes (2)
Spirometric values(FEF25-75,FEV1,FEV1/FVC)
Spirometric values were evaluated at week 6 in the treatment and non-treatment groups.
Measured: 6 weeks
Asthma control test scores
Asthma control test scores were evaluated at week 6 in the treatment and non-treatment groups.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startMay 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungbuk National University
- Sponsor type
- University, hospital or other
- Investigators
- Youn-Soo Hahn, MD, PhD, Principal investigator, Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340118
- Sponsor's protocol ID
- WC asthma treatment based FeNO
- Status last verified
- Apr 2011
- First submitted
- 15 Apr 2011
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Improvement of Exhaled Nitric Oxide and FEF25-75 After Treatment With Inhaled Corticosteroid in Children With Controlled Asthma
- ClinicalTrials.gov ID
- NCT01340118
- Acronym / sponsor ID
- WC asthma treatment based FeNO
- Conditions
- Asthma
- Keywords
- Asthma, FEF25-75, exhaled nitric oxide, inhaled corticosteroid, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Chungbuk National UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Experimental | Drug: BudesonidePatients 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. |
| remain untreated | No intervention | – |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- who had significant pulmonary disease other than asthma or a history of gastroesophageal reflux
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonideonce daily inhalation with 400 µg budesonide (dry powder)during 6 weeks | Drug | Budesonide |
Primary outcome
FeNO
Time frame: 6 weeks after enrollment
FeNO was measured at week 6 in the treatment and non-treatment groups.
2 secondary outcomes
Spirometric values(FEF25-75,FEV1,FEV1/FVC)
Time frame: 6 weeks
Asthma control test scores
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youn-Soo Hahn, MD, PhD principal investigator
Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide in people with Asthma, run by Chungbuk National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FeNO (time frame: 6 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2011.