Evaluation of an Asthma Treatment Strategy Based on Exhaled Nitric Oxide Measurements in Adolescents
Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies (DAIT ICAC-02)
1 other identifier
interventional
547
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Aug 2004
Typical duration for not_applicable asthma
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 14, 2005
CompletedFirst Posted
Study publicly available on registry
June 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFebruary 10, 2017
February 1, 2017
2.3 years
June 14, 2005
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean maximum symptom days per 2 weeks, as assessed by questionnaire
At Visits 3 and 8
Secondary Outcomes (9)
Days with wheeze
Throughout study
Days of slowed down or discontinued physical activities due to asthma
Throughout study
Nights awoken due to asthma
Throughout study
Days on which plans were changed due to asthma
Throughout study
Days missed school/work due to asthma
Throughout study
- +4 more secondary outcomes
Study Arms (2)
Reference Strategy
ACTIVE COMPARATORParticipants in the reference strategy group will undergo the eNO procedure but will follow NAEPP guidelines alone for asthma treatment without eNO measurements for the rest of the study.
Biomarker Strategy
EXPERIMENTALParticipants in the biomarker strategy group will follow NAEPP treatment guidelines, as well as eNO measurements, to determine asthma treatment at each study visit.
Interventions
Used for both regular asthma control and as a rescue inhaler
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of asthma made by a doctor over a year prior to study entry OR symptoms have been present more than a year if the diagnosis was made less than a year prior to study entry
- Have symptoms consistent with persistent asthma OR have evidence of uncontrolled disease. More information on this criterion can be found in the DAIT ICAC-01 protocol.
- Currently reside in a pre-selected area containing at least 20% of households below the U.S. government poverty level
- Do not smoke and have not used smokeless tobacco products in the year prior to study entry
- Able to perform eNO measurement procedures and spirometry at study screening
- Parent or guardian willing to provide informed consent, if applicable
- History of clinical varicella (chicken pox) or have received varicella vaccine
- Planning to stay in the area for the next 12 months
- Primary language is English. Spanish speakers may enroll at centers with Spanish-speaking staff.
- Parent or guardian primarily speaks English (or Spanish at centers with Spanish-speaking staff), for participants with parent or guardian providing informed consent
- Willing to allow the study physician to manage disease for the duration of the study
- Willing to change asthma medications in order to follow the protocol
You may not qualify if:
- Adherence to controller medication between Visits 1 and 2 is less than 25%. More information on this criterion can be found in the DAIT ICAC-01 protocol.
- Determined to have mild intermittent asthma at Visit 1
- Have had a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure in the 5 years prior to study entry
- Have significant medical illnesses other than asthma. More information on this criterion can be found in the DAIT ICAC-01 protocol.
- Unable to use a metered-dose inhaler for administration of a beta-agonist rescue medication or a dry powder inhaler for the administration of asthma controller regimens
- Known hypersensitivity to any medications commonly used for the treatment of asthma
- Have not completed a home evaluation within 4 weeks of study screening
- Currently participating in another asthma-related drug or intervention study, or have participated in another asthma-related drug or intervention study in the month prior to study entry
- Does not sleep at least 4 nights per week in one home
- Lives with a foster parent (not applicable if patient is able to provide informed consent)
- Does not have access to a phone
- Requires certain medications. More information on this criterion can be found in the DAIT ICAC-01 protocol.
- Urine cotinine level above 100 ng/ml at study screening
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of Arizona (DAIT-ICAC-01/02)
Tucson, Arizona, 85724, United States
National Jewish Medical and Research Center (DAIT-ICAC-01/02)
Denver, Colorado, 80206, United States
Howard University
Washington D.C., District of Columbia, 20010, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mount Sinai (DAIT-ICAC-01/02)
New York, New York, 10032, United States
Rho Federal System Division, Inc- data coordinating center
Chapel Hill, North Carolina, 27517, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
University of Texas Southwestern (DAIT-ICAC-01/02)
Dallas, Texas, 75235, United States
University of Wisconsin-an administrative site
Madison, Wisconsin, 53792, United States
Related Publications (6)
Reid DW, Johns DP, Feltis B, Ward C, Walters EH. Exhaled nitric oxide continues to reflect airway hyperresponsiveness and disease activity in inhaled corticosteroid-treated adult asthmatic patients. Respirology. 2003 Dec;8(4):479-86. doi: 10.1046/j.1440-1843.2003.00495.x.
PMID: 14629652BACKGROUNDStrunk RC, Szefler SJ, Phillips BR, Zeiger RS, Chinchilli VM, Larsen G, Hodgdon K, Morgan W, Sorkness CA, Lemanske RF Jr; Childhood Asthma Research and Education Network of the National Heart, Lung, and Blood Institute. Relationship of exhaled nitric oxide to clinical and inflammatory markers of persistent asthma in children. J Allergy Clin Immunol. 2003 Nov;112(5):883-92. doi: 10.1016/j.jaci.2003.08.014.
PMID: 14610474BACKGROUNDLangley SJ, Goldthorpe S, Custovic A, Woodcock A. Relationship among pulmonary function, bronchial reactivity, and exhaled nitric oxide in a large group of asthmatic patients. Ann Allergy Asthma Immunol. 2003 Oct;91(4):398-404. doi: 10.1016/S1081-1206(10)61688-2.
PMID: 14582820BACKGROUNDJones SL, Herbison P, Cowan JO, Flannery EM, Hancox RJ, McLachlan CR, Taylor DR. Exhaled NO and assessment of anti-inflammatory effects of inhaled steroid: dose-response relationship. Eur Respir J. 2002 Sep;20(3):601-8. doi: 10.1183/09031936.02.00285302.
PMID: 12358335BACKGROUNDSzefler SJ, Mitchell H, Sorkness CA, Gergen PJ, O'Connor GT, Morgan WJ, Kattan M, Pongracic JA, Teach SJ, Bloomberg GR, Eggleston PA, Gruchalla RS, Kercsmar CM, Liu AH, Wildfire JJ, Curry MD, Busse WW. Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial. Lancet. 2008 Sep 20;372(9643):1065-72. doi: 10.1016/S0140-6736(08)61448-8.
PMID: 18805335RESULTArroyave WD, Rabito FA, Carlson JC, Sever ML, Lefante J. Asthma severity, not asthma control, is worse in atopic compared with nonatopic adolescents with asthma. Ann Allergy Asthma Immunol. 2016 Jan;116(1):18-25. doi: 10.1016/j.anai.2015.10.015. Epub 2015 Nov 7.
PMID: 26560898RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Busse, MD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2005
First Posted
June 15, 2005
Study Start
August 1, 2004
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
February 10, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.