AsthmaPhase 4NCT00522782
Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children
A Phase 4 study testing Nebulized Budesonide and Nitric Oxide Analyzer in people with Asthma, run by AAADRS Clinical Research Center at 1 site in United States.
Trial summary
To study the improvement in airway inflammation in children with asthma non-invasively with exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg daily. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Asthma
- What is being tested?
- Nebulized Budesonide and Nitric Oxide Analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 2009
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Asthma diagnosis previously for 6 months
- Past asthma medication without change for previous 6 months
- Increased NO levels and ability to perform maneuver
- ICF signed by parents
Who cannot join
- Systemic steroids in past 60 days,inhaled/nebulized steroids in past 4 weeks
- Hospitalization within 3 months
- Upper or lower airways active infection or cigarette smoke direct exposure
- Use of other asthma medications other than bronchodilators one month prior and during the trial
- Noncompliance
Trial locations and contacts
1 site in 1 country.
United States1 site
AAADRS Clinical Research Center
Coral Gables, Florida, 33134
About this study
Official title: Phase IV Study of the Effect of Nebulized Budesonide on Exhaled Nitric Oxide in Children, Four to Six Years of Age, With Asthma
To study the improvement in airway inflammation in children with asthma non-invasively with exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg daily.
Read the detailed description
Comparisons will be made before and after 2 week therapy of nebulized budesonide in children not on prior anti-inflammatory medications.
- Conditions
- Asthma
- Being tested
- Nebulized Budesonide, Nitric Oxide Analyzer
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized BudesonideDrug
Also called Pulmicort Respules 0.5mg/2ml nebulized
Pulmicort Respules 0.5mg/2cc
Nitric Oxide AnalyzerDevice
Also called Niox NO analyzer
Niox NO analyzer
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Nebulized budesonide Receives: Drug: Nebulized Budesonide; Device: Nitric Oxide Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled breath nitric oxide pre- to post treatment
Measured: two weeks
Secondary outcomes (1)
Spirometry with peak flow measurements and daily diary scores
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2008
- Study completionJan 2009
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AAADRS Clinical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Miguel J Lanz, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522782
- Sponsor's protocol ID
- IRUSBUPR-0062
- Status last verified
- Jan 2009
- First submitted
- 28 Aug 2007
- Last updated
- 23 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of the Effect of Nebulized Budesonide on Exhaled Nitric Oxide in Children, Four to Six Years of Age, With Asthma
- ClinicalTrials.gov ID
- NCT00522782
- Acronym / sponsor ID
- IRUSBUPR-0062
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AAADRS Clinical Research CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 30 Aug 2007 (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.
To study the improvement in airway inflammation in children with asthma non-invasively with exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg daily.
Detailed description
Comparisons will be made before and after 2 week therapy of nebulized budesonide in children not on prior anti-inflammatory medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Nebulized Budesonide, Device: Nitric Oxide AnalyzerNebulized budesonide |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Asthma diagnosis previously for 6 months
- Past asthma medication without change for previous 6 months
- Increased NO levels and ability to perform maneuver
- ICF signed by parents
Key exclusion criteria (5 listed)
- Systemic steroids in past 60 days,inhaled/nebulized steroids in past 4 weeks
- Hospitalization within 3 months
- Upper or lower airways active infection or cigarette smoke direct exposure
- Use of other asthma medications other than bronchodilators one month prior and during the trial
- Noncompliance
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 |
|---|---|---|
| Nebulized BudesonideAlso: Pulmicort Respules 0.5mg/2ml nebulizedPulmicort Respules 0.5mg/2cc | Drug | A |
| Nitric Oxide AnalyzerAlso: Niox NO analyzerNiox NO analyzer | Device | A |
Primary outcome
Exhaled breath nitric oxide pre- to post treatment
Time frame: two weeks
1 secondary outcome
Spirometry with peak flow measurements and daily diary scores
Time frame: two 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 23 Jan 2009.
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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.
Miguel J Lanz, MD principal investigator
Principal Investigator
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 Nebulized Budesonide and Nitric Oxide Analyzer in people with Asthma, run by AAADRS Clinical Research Center at 1 site in United States.
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 4 inclusion and 5 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 23 Jan 2009. 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 United States. 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?
Exhaled breath nitric oxide pre- to post treatment (time frame: two weeks). 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 23 Jan 2009.