Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00388570
Status:
COMPLETED
Last Update Posted:
2011-11-04
First Post:
2006-10-16
Brief Title:
Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment
Sponsor:
Aerocrine AB
Organization:
Aerocrine AB
Study Overview
Official Title:
A Multicenter Device Randomized Open-label Prospective Single-cohort Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eNOugh
Brief Summary:
The purpose of this study is to demonstrate substantial equivalence between two medical devices which measure nitric oxide in exhaled breath NIOX MINO and NIOX in Symptomatic Asthmatic Adults and Children
Detailed Description:
Asthma is a chronic inflammatory disorder of the airways Chronically inflamed airways are hyperresponsive they become obstructed and airflow is limited by bronchoconstriction mucus plugs and increased inflammation when airways are exposed to various risk factors Asthma causes recurring episodes of wheezing breathlessness chest tightness and coughing particularly at night or in the early morning
NO is an important endogenous regulatory molecule that is widely distributed throughout the body The detection of NO in exhaled air was first reported in 1991 and soon after it was shown that the levels NO in exhaled air are elevated in patients with asthma There is now much evidence showing that measurement of the concentration of NO in exhaled air offers a useful non-invasive method of assessing inflammatory airway disease
Exhaled NO is not increased during bronchospasm unless there is coexisting inflammation Exhaled NO may have a valuable role in differentiating between the inflammatory and bronchospastic components of clinical asthma and is also useful for guiding the therapeutic use of steroids and other anti-inflammatory agents
A study on asthmatics and non-asthmatics subjects has shown that substantial equivalence exists between the stationary device NIOX and the hand held device NIOX MINO when comparing NO measurements when similar conditions are considered and examinations are made as consistently as possible
In a study with the stationary device NIOX exhaled NO was measured before and after two weeks of inhaled corticosteroid treatment in unstable steroid-naïve adult and paediatric asthmatic subjects The result was a 505 mean reduction of exhaled NO The change in exhaled NO was also compared to change in standard asthma outcome measures asthma symptoms and spirometry
NO is an important endogenous regulatory molecule that is widely distributed throughout the body The detection of NO in exhaled air was first reported in 1991 and soon after it was shown that the levels NO in exhaled air are elevated in patients with asthma There is now much evidence showing that measurement of the concentration of NO in exhaled air offers a useful non-invasive method of assessing inflammatory airway disease
Exhaled NO is not increased during bronchospasm unless there is coexisting inflammation Exhaled NO may have a valuable role in differentiating between the inflammatory and bronchospastic components of clinical asthma and is also useful for guiding the therapeutic use of steroids and other anti-inflammatory agents
A study on asthmatics and non-asthmatics subjects has shown that substantial equivalence exists between the stationary device NIOX and the hand held device NIOX MINO when comparing NO measurements when similar conditions are considered and examinations are made as consistently as possible
In a study with the stationary device NIOX exhaled NO was measured before and after two weeks of inhaled corticosteroid treatment in unstable steroid-naïve adult and paediatric asthmatic subjects The result was a 505 mean reduction of exhaled NO The change in exhaled NO was also compared to change in standard asthma outcome measures asthma symptoms and spirometry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None