Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114413
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2005-06-14
Brief Title:
Evaluation of an Asthma Treatment Strategy Based on Exhaled Nitric Oxide Measurements in Adolescents
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Asthma Control Evaluation ACE A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies DAIT ICAC-02
Status:
COMPLETED
Status Verified Date:
2017-02
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:
None
Brief Summary:
The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures exhaled nitric oxide eNO to indicate disease progression is more effective in treating asthma symptoms when combined with existing asthma treatment guidelines than treatment using the guidelines alone
Detailed Description:
Over the past two decades the prevalence of asthma has dramatically increased in many parts of the world The current National Asthma Education and Prevention Program NAEPP identifies inhaled corticosteroids ICS as the preferred long-term control therapy for all forms of persistent asthma However there is still a significant proportion of patients with persistent asthma who are not receiving ICS therapy or do not follow their treatment plan Individualized asthma treatment plans are needed The use of biomarkers in addition to NAEPP guidelines may help enhance the level of asthma assessment guide medication regimens and improve overall asthma control This study will determine whether NAEPP-recommended treatment combined with eNO measurement is more effective in reducing asthma symptoms than NAEPP-recommended treatment alone ICAC-01 will last 46 weeks and will comprise 8 study visits
ICAC-01 also includes a mechanistic sub-study ICAC-02 Its primary objective is to determine whether highly sensitized compared to weakly sensitized asthmatic subjects have more severe asthma as defined by the levels at randomization to the completion of ICAC-01 To address the primary objective of ICAC-02 the study will include all the participants enrolled in ICAC-01 with dust mite- cockroach- andor alternaria-specific IgE levels within certain parameters
ICAC-01 also includes a mechanistic sub-study ICAC-02 Its primary objective is to determine whether highly sensitized compared to weakly sensitized asthmatic subjects have more severe asthma as defined by the levels at randomization to the completion of ICAC-01 To address the primary objective of ICAC-02 the study will include all the participants enrolled in ICAC-01 with dust mite- cockroach- andor alternaria-specific IgE levels within certain parameters
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