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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.
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:
Participants will attempt 2 measurements taken using the 6-sec mode followed by 2 measurements using the 10 second exhalation mode or vice versa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | After a single 1-2 hour visit |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy and Asthmatic 4 - 6 year old children.
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Rickard, MD | Aerocrine AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Allergy & Immunology Research | Gilbert | Arizona | United States | |||
| Allergy and Asthma Specialists |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 13, 2017 | |
| Reset | Aug 15, 2018 | |
| Release | Apr 9, 2019 | |
| Reset | Jun 28, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 13, 2017 | Aug 15, 2018 | |||
| Apr 9, 2019 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Blue Bell |
| Pennsylvania |
| United States |
| Allergy Partners of North Texas | Dallas | Texas | United States |
| Jun 28, 2019 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |