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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
547
Used for both regular asthma control and as a rescue inhaler
measured by Aerocrine® NIOX device
University of Arizona (DAIT-ICAC-01/02)
Tucson, Arizona, United States
National Jewish Medical and Research Center (DAIT-ICAC-01/02)
Denver, Colorado, United States
Howard University
Washington D.C., District of Columbia, United States
Mean maximum symptom days per 2 weeks, as assessed by questionnaire
Time frame: At Visits 3 and 8
Days with wheeze
Time frame: Throughout study
Days of slowed down or discontinued physical activities due to asthma
Time frame: Throughout study
Nights awoken due to asthma
Time frame: Throughout study
Days on which plans were changed due to asthma
Time frame: Throughout study
Days missed school/work due to asthma
Time frame: Throughout study
Unscheduled office/clinic visit due to asthma
Time frame: Throughout study
Emergency room/urgent care center due to asthma
Time frame: Throughout study
Hospitalization due to asthma
Time frame: Throughout study
Number of asthma exacerbations requiring prednisone or prednisone equivalent
Time frame: Throughout study
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Children's Memorial Hospital
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mount Sinai (DAIT-ICAC-01/02)
New York, New York, United States
Rho Federal System Division, Inc- data coordinating center
Chapel Hill, North Carolina, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
...and 2 more locations