AsthmaNCT02661984
Measurement of FeNO in Young Children With the NIOX VERO
An observational study of Asthma, run by Aerocrine AB at 3 sites in United States.
Trial summary
FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. Interpretation of FeNO profiles is based on the nitric oxide plateau. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 102 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2016to 31 May 2017
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy and Asthmatic 4 - 6 year old children.
Who may be able to join
- Male or female 4, 5 and 6 years old,
- Primary Language: English or Spanish, and
- Healthy (e.g., no pulmonary disease) or Asthmatic (if asthmatic, they must have a physician diagnosis of asthma).
Who cannot join
- Pulmonary Disease Status: Any disease other than asthma.
- In the opinion of the investigator, has severe or uncontrolled asthma (defined as having a) 2 or more exacerbations within the last year that required the use of systemic corticosteroids, or b) 1 or more hospitalizations, ICU stays or mechanical ventilations within the last year).
- Has taken their reliever inhaler within 4 - 6 hours from the FeNO measurements.
- Has acute asthma symptoms, respiratory illness (e.g. cold, flu), or sinusitis.
- Has had food or beverage intake (other than water) or has participated in strenuous exercise within 1 hour prior to FeNO measurement.
- Has a family relationship with the Operator or Study Personnel (persons who are family members of the Operator or Study Personnel are not eligible to participate).
- Has a Parent/Guardian who is unable or unwilling to provide informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Allergy and Asthma Specialists
Blue Bell, Pennsylvania
Allergy Partners of North Texas
Dallas, Texas
Arizona Allergy & Immunology Research
Gilbert, Arizona
About this study
Official title: A Randomized, Multi-Center, Single-Visit, Clinical Investigation to Assess the Degree of Agreement and Feasibility of Measuring Exhaled Nitric Oxide in Children, Aged 4-6 Years Old, With the NIOX VERO Using the 6 Second Exhalation Mode as Compared With the 10 Second Exhalation Mode
FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. Interpretation of FeNO profiles is based on the nitric oxide plateau. To achieve plateau, the duration of exhalation must be sufficient (at least 4 seconds for children <12 years and > 6 seconds for children > 12 years (ATS/ERS, 2005).
Measurement of FeNO using the 6-sec mode may provide a viable alternative in children as young as age 4 years who may have difficulty maintaining exhalation for a full 10 seconds.
Read the detailed description
The primary objective is to assess the degree of agreement of FeNO measured with the NIOX VERO using the 6-sec and 10-sec modes.
The secondary objectives of the Clinical Investigation are to:
- Assess the ability of participants to use the NIOX VERO for measuring FeNO in both exhalation modes, and
- Compare the repeatability of FeNO measured with the NIOX VERO in both exhalation modes.
Participants will attempt 2 measurements taken using the 6-sec mode followed by 2 measurements using the 10 second exhalation mode or vice versa.
- Conditions
- Asthma
- Keywords
- FeNO, 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 |
|---|---|---|
| Healthy (no pulmonary disease) | Healthy children 4 - 6 years old with no pulmonary disease and not exhibiting respiratory illness or sinusitis. | |
| Asthmatic (physician diagnosed) | Asthmatic children 4 - 6 years old not exhibiting acute asthma symptoms, respiratory illness or sinusitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the analysis of the agreement of successful FeNO measurements in the 10 second and the 6 second exhalation modes.
This is a single visit study.
Measured: After a single 1-2 hour visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016
- Study completion31 May 2017 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerocrine AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy Rickard, MD, Study director, Aerocrine AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661984
- Sponsor's protocol ID
- AER-052
- Status last verified
- May 2017
- First submitted
- 5 Jan 2016
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Single-Visit, Clinical Investigation to Assess the Degree of Agreement and Feasibility of Measuring Exhaled Nitric Oxide in Children, Aged 4-6 Years Old, With the NIOX VERO Using the 6 Second Exhalation Mode as Compared With the 10 Second Exhalation Mode
- ClinicalTrials.gov ID
- NCT02661984
- Acronym / sponsor ID
- AER-052
- Conditions
- Asthma
- Keywords
- FeNO, exhaled nitric oxide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Aerocrine ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- 31 May 2017 (estimated)
- First posted
- 25 Jan 2016 (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.
FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. Interpretation of FeNO profiles is based on the nitric oxide plateau. To achieve plateau, the duration of exhalation must be sufficient (at least 4 seconds for children <12 years and > 6 seconds for children > 12 years (ATS/ERS, 2005).
Measurement of FeNO using the 6-sec mode may provide a viable alternative in children as young as age 4 years who may have difficulty maintaining exhalation for a full 10 seconds.
Detailed description
The primary objective is to assess the degree of agreement of FeNO measured with the NIOX VERO using the 6-sec and 10-sec modes.
The secondary objectives of the Clinical Investigation are to:
- Assess the ability of participants to use the NIOX VERO for measuring FeNO in both exhalation modes, and
- Compare the repeatability of FeNO measured with the NIOX VERO in both exhalation modes.
Participants will attempt 2 measurements taken using the 6-sec mode followed by 2 measurements using the 10 second exhalation mode or vice versa.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy (no pulmonary disease) | – | –Healthy children 4 - 6 years old with no pulmonary disease and not exhibiting respiratory illness or sinusitis. |
| Asthmatic (physician diagnosed) | – | –Asthmatic children 4 - 6 years old not exhibiting acute asthma symptoms, respiratory illness or sinusitis. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy and Asthmatic 4 - 6 year old children.
Key inclusion criteria (3 listed)
- Male or female 4, 5 and 6 years old,
- Primary Language: English or Spanish, and
- Healthy (e.g., no pulmonary disease) or Asthmatic (if asthmatic, they must have a physician diagnosis of asthma).
Key exclusion criteria (7 listed)
- Pulmonary Disease Status: Any disease other than asthma.
- In the opinion of the investigator, has severe or uncontrolled asthma (defined as having a) 2 or more exacerbations within the last year that required the use of systemic corticosteroids, or b) 1 or more hospitalizations, ICU stays or mechanical ventilations within the last year).
- Has taken their reliever inhaler within 4 - 6 hours from the FeNO measurements.
- Has acute asthma symptoms, respiratory illness (e.g. cold, flu), or sinusitis.
- Has had food or beverage intake (other than water) or has participated in strenuous exercise within 1 hour prior to FeNO measurement.
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
The primary endpoint will be the analysis of the agreement of successful FeNO measurements in the 10 second and the 6 second exhalation modes.
Time frame: After a single 1-2 hour visit
This is a single visit study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Individual participant dataSharing planned: No
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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.
Kathy Rickard, MD study director
Aerocrine AB
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Aerocrine AB at 3 sites 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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?
The primary endpoint will be the analysis of the agreement of successful FeNO measurements in the 10 second and the 6 second exhalation modes. (time frame: After a single 1-2 hour visit). 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 15 May 2017.