Evaluation of an Asthma Treatment Strategy Based on Exhaled Nitric Oxide Measurements in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00114413
First received: June 14, 2005
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Asthma
Drug: Inhaled corticosteroids
Procedure: eNO measurement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies (DAIT ICAC-02)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Mean maximum symptom days per 2 weeks, as assessed by questionnaire [ Time Frame: At Visits 3 and 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Days with wheeze [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Days of slowed down or discontinued physical activities due to asthma [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Nights awoken due to asthma [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Days on which plans were changed due to asthma [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Days missed school/work due to asthma [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Unscheduled office/clinic visit due to asthma [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Emergency room/urgent care center due to asthma [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Hospitalization due to asthma [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Number of asthma exacerbations requiring prednisone or prednisone equivalent [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 547
Study Start Date: August 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reference Strategy
Participants 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.
Drug: Inhaled corticosteroids
Used for both regular asthma control and as a rescue inhaler
Experimental: Biomarker Strategy
Participants in the biomarker strategy group will follow NAEPP treatment guidelines, as well as eNO measurements, to determine asthma treatment at each study visit.
Drug: Inhaled corticosteroids
Used for both regular asthma control and as a rescue inhaler
Procedure: eNO measurement
measured by Aerocrine® NIOX device

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- and/or alternaria-specific IgE levels within certain parameters.

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114413

Locations
United States, Arizona
University of Arizona (DAIT-ICAC-01/02)
Tucson, Arizona, United States, 85724
United States, Colorado
National Jewish Medical and Research Center (DAIT-ICAC-01/02)
Denver, Colorado, United States, 80206
United States, District of Columbia
Howard University
Washington DC, District of Columbia, United States, 20010
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Mount Sinai (DAIT-ICAC-01/02)
New York, New York, United States, 10032
United States, North Carolina
Rho Federal System Division, Inc- data coordinating center
Chapel Hill, North Carolina, United States, 27517
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Texas
University of Texas Southwestern (DAIT-ICAC-01/02)
Dallas, Texas, United States, 75235
United States, Wisconsin
University of Wisconsin-an administrative site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Investigators
Principal Investigator: William Busse, MD University of Wisconsin, Madison
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00114413     History of Changes
Other Study ID Numbers: DAIT ICAC-01/DAIT ICAC-02
Study First Received: June 14, 2005
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Exhaled Nitric Oxide
Lung
Urban Health
Child
Adolescent

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on July 24, 2014