Asthma Clinical Trial
Official title:
Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies (DAIT ICAC-02)
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.
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- and/or alternaria-specific IgE
levels within certain parameters.
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