Asthma in ChildrenNCT01645397
Exhaled Nitric Oxide and Airway Caliber in Children With Asthma
An observational study of Asthma in Children, run by Atlantic Health System at 1 site in United States.
Trial summary
The purpose of this study is to assess if in steroid naïve asthmatic children with elevated baseline exhaled nitric oxide, treatment with inhaled steroid and normalization of exhaled nitric oxide level results in restoration of the bronchodilator response to deep inhalation. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Asthma in Children
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Aug 2013
- Phase
- Observational
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children, six years of age or older, with asthma attending asthma clinic
Who may be able to join
- Age: > 6 years at age of screening.
- Physician diagnosed asthma
- Elevated exhaled NO at initial evaluation (>25ppb)
- Be able to reproducibly perform DI maneuvers and all other pulmonary function testing
- Be clinically stable for at least 2 weeks prior to screening with no evidence of acute upper or lower respiratory infection or current pulmonary exacerbation.
- Has not been on inhaled or oral steroid for at least 4 weeks prior to enrollment in the study.
- Parent/child willingness to enroll in the study and provide written informed consent.
- Be able to present for the required study visits.
Who cannot join
- Chest wall or spinal column deformity; known cardiac, neuromuscular, or other chronic diseases
- Use of beta agonist, theophylline, leukotriene receptor antagonists, or caffeine-containing soft drinks 12 hr prior to the study.
- Use of inhaled steroid in the past 4 weeks.
- Respiratory infection or asthma exacerbation in the previous 2 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Goryeb Children's Hospital, Atlantic Health
Morristown, New Jersey, 07960
About this study
The purpose of this study is to assess if in steroid naïve asthmatic children with elevated baseline exhaled nitric oxide, treatment with inhaled steroid and normalization of exhaled nitric oxide level results in restoration of the bronchodilator response to deep inhalation.
Read the detailed description
Previous studies have shown that a deep inhalation (DI) would increase airway caliber in normal subjects. Whereas in asthmatics with spontaneous bronchoconstriction (obstruction of the airway), DI was shown to worsen airway obstruction. The mechanism for this variability in response to DI is not well-understood, but seems to be a key in understanding the pathophysiology of the disease, and possibly in the development of an effective therapy. Air way inflammation resulting in airway wall thickening and peribronchial edema is thought to play a role how the airway responds to deep inhalation. This study assess if reduction in airway inflammation (as measured by level of exhaled NO)results in optimization of the bronchodilator response to deep inhalation
- Conditions
- Asthma in Children
- Keywords
- Asthma, Deep inhalation, Exhaled nitric oxide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma, elevated exhaled NO | Children with asthma with elevated exhaled NO at initial evaluation (>25ppb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in M/P40 ratio from baseline at 4 weeks of treatment with inhaled steroid
M/P40 ratio is defined as the ratio of flow at 40% of FVC (forced vital capacity) on the flow-volume curve after maximal inspiration to flow at 40% of FVC on the flow-volume curve after partial (60%-70% of FVC) inspiration (M/P40 ratio)
Measured: at baseline and 4 weeks later
Secondary outcomes (1)
Change in Ratio of post DI to pre DI airway resistance from baseline at 4 weeks of treatment with inhaled steroid
Post-DI to pre-DI airway resistance at 5 Hz (R5) ratio (as measured by impulse oscillometry) from baseline (elevated exhaled NO) to 4-6 weeks of treatment.
Measured: at baseline and 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Breitwieser, Atlantic Health System
- Investigators
- Dagnachew Assefa, MD, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645397
- Sponsor's protocol ID
- R10-06-013
- Status last verified
- Jan 2014
- First submitted
- 23 Jun 2011
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Nitric Oxide and Airway Caliber in Children With Asthma
- ClinicalTrials.gov ID
- NCT01645397
- Acronym / sponsor ID
- R10-06-013
- Conditions
- Asthma in Children
- Keywords
- Asthma, Deep inhalation, Exhaled nitric oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Jul 2012 (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.
The purpose of this study is to assess if in steroid naïve asthmatic children with elevated baseline exhaled nitric oxide, treatment with inhaled steroid and normalization of exhaled nitric oxide level results in restoration of the bronchodilator response to deep inhalation.
Detailed description
Previous studies have shown that a deep inhalation (DI) would increase airway caliber in normal subjects. Whereas in asthmatics with spontaneous bronchoconstriction (obstruction of the airway), DI was shown to worsen airway obstruction. The mechanism for this variability in response to DI is not well-understood, but seems to be a key in understanding the pathophysiology of the disease, and possibly in the development of an effective therapy. Air way inflammation resulting in airway wall thickening and peribronchial edema is thought to play a role how the airway responds to deep inhalation. This study assess if reduction in airway inflammation (as measured by level of exhaled NO)results in optimization of the bronchodilator response to deep inhalation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma, elevated exhaled NO | – | –Children with asthma with elevated exhaled NO at initial evaluation (>25ppb) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children, six years of age or older, with asthma attending asthma clinic
Key inclusion criteria (8 listed)
- Age: > 6 years at age of screening.
- Physician diagnosed asthma
- Elevated exhaled NO at initial evaluation (>25ppb)
- Be able to reproducibly perform DI maneuvers and all other pulmonary function testing
- Be clinically stable for at least 2 weeks prior to screening with no evidence of acute upper or lower respiratory infection or current pulmonary exacerbation.
Key exclusion criteria (4 listed)
- Chest wall or spinal column deformity; known cardiac, neuromuscular, or other chronic diseases
- Use of beta agonist, theophylline, leukotriene receptor antagonists, or caffeine-containing soft drinks 12 hr prior to the study.
- Use of inhaled steroid in the past 4 weeks.
- Respiratory infection or asthma exacerbation in the previous 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in M/P40 ratio from baseline at 4 weeks of treatment with inhaled steroid
Time frame: at baseline and 4 weeks later
M/P40 ratio is defined as the ratio of flow at 40% of FVC (forced vital capacity) on the flow-volume curve after maximal inspiration to flow at 40% of FVC on the flow-volume curve after partial (60%-70% of FVC) inspiration (M/P40 ratio)
1 secondary outcome
Change in Ratio of post DI to pre DI airway resistance from baseline at 4 weeks of treatment with inhaled steroid
Time frame: at baseline and 4 weeks later
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 16 Jan 2014.
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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.
Dagnachew Assefa, MD principal investigator
Atlantic Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by Atlantic Health System 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 8 inclusion and 4 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 16 Jan 2014. 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.
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?
Change in M/P40 ratio from baseline at 4 weeks of treatment with inhaled steroid (time frame: at baseline and 4 weeks later). 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 16 Jan 2014.