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

Asthma Clinical Trial

Official title:

Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies (DAIT ICAC-02)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114413
• Other study ID #: DAIT ICAC-01/DAIT ICAC-02
• Status: Completed
• Phase: N/A
• First received: June 14, 2005
• Last updated: February 8, 2017
• Start date: August 2004
• Est. completion date: November 2006

Study information

• Verified date: February 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Inhaled corticosteroids
Used for both regular asthma control and as a rescue inhaler

Procedure:
• eNO measurement
measured by Aerocrine® NIOX device

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Rho Federal System Division, Inc- data coordinating center	Chapel Hill	North Carolina
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	University of Texas Southwestern (DAIT-ICAC-01/02)	Dallas	Texas
United States	National Jewish Medical and Research Center (DAIT-ICAC-01/02)	Denver	Colorado
United States	University of Wisconsin-an administrative site	Madison	Wisconsin
United States	Mount Sinai (DAIT-ICAC-01/02)	New York	New York
United States	Washington University School of Medicine	St. Louis	Missouri
United States	University of Arizona (DAIT-ICAC-01/02)	Tucson	Arizona
United States	Howard University	Washington DC	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Arroyave 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. — View Citation

Jones 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. — View Citation

Langley 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. — View Citation

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. — View Citation

Strunk 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. — View Citation

Szefler 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean maximum symptom days per 2 weeks, as assessed by questionnaire		At Visits 3 and 8
Secondary	Days with wheeze		Throughout study
Secondary	Days of slowed down or discontinued physical activities due to asthma		Throughout study
Secondary	Nights awoken due to asthma		Throughout study
Secondary	Days on which plans were changed due to asthma		Throughout study
Secondary	Days missed school/work due to asthma		Throughout study
Secondary	Unscheduled office/clinic visit due to asthma		Throughout study
Secondary	Emergency room/urgent care center due to asthma		Throughout study
Secondary	Hospitalization due to asthma		Throughout study
Secondary	Number of asthma exacerbations requiring prednisone or prednisone equivalent		Throughout study

External Links

•   Division of Allergy, Immunology, and Transplantation (DAIT) website
•   National Institute of Allergy and Infectious Diseases (NIAID) website