Asthma Phenotypes in the Inner City

NCT01383941 | Completed DMC

• 1 other identifier: DAIT ICAC-19
• Study Type: observational
• Target: 717
• Locations: 1 country
• Sites: 9

Brief Summary

This is an epidemiologic, multi-center, cross-sectional study to define the phenotypic characteristics of Difficult-to-Treat asthma, among children between the ages of 6 to 17 years, receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis.

Conditions

Asthma; Rhinitis

Keywords

asthma; rhinitis; difficult-to-treat asthmatic; phenotypes

Outcome Measures

Primary Outcomes (1)

• Phenotypic Identification: Discriminating Difficult-to-Treat from Easy-to-Treat Asthmatics In a Study Cohort

  This study is not a clinical trial with a single disease outcome or endpoint. The objective is to determine distinct characteristics that will discriminate Difficult-to-Treat from Easy-to-Treat asthmatic children in a employing multiple domains. Statistical procedures will be used to assess the relative strength of multiple relationships among many variables simultaneously.

  Baseline through 12 months of standardized asthma and rhinitis treatment

Secondary Outcomes (2)

• Identification of Asthma Phenotypes

  Baseline through 12 months of standardized asthma and rhinitis treatment

• Identification of Rhinitis Phenotypes

  Baseline through 12 months of standardized asthma and rhinitis treatment

Study Arms (1)

Subjects with Mild to Severe Asthma

This is an epidemiologic, multi-center, cross-sectional study to define the phenotypic characteristics of Difficult-to-Treat asthma, among children receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis.

Drug: Guidelines-based asthma and rhinitis/rhinosinusitis therapy

Interventions

Guidelines-based asthma and rhinitis/rhinosinusitis therapy DRUG

All participants receive standardized asthma and rhinitis treatment. Asthma and rhinitis medication regimens were based on 1.) the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report -3 (EPR-3) and 2.) the Rhinitis and its Impact on Asthma (ARIA) 2008 guidelines-derived treatment algorithms. References: 1.) J Allergy Clin Immunol 2007; Volume 120, Issue 5, Supplement s93-140. 2.) Allergy 2008; Volume 63, Issue Supplement s86, pages 7-160.

Also known as: asthma controller medications, rhinitis/rhinosinusitis controller medications

Subjects with Mild to Severe Asthma

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Inner-city Asthma Consortium (ICAC) children with mild to severe asthma

You may qualify if:

• Participants who meet all of the following criteria are eligible for enrollment. Participants may be reassessed if not initially eligible. Participants are eligible if they:
• Are male or female ages 6-17 years, inclusive, at recruitment;
• Have a physician diagnosis of asthma;
• Have had ≥ 2 episodes of short-acting beta-agonist administration within the past 12 months, exclusive of use associated with exercise-induced symptoms;
• Have a primary place of residence located in one of the pre-selected recruitment census tracts as defined in the APIC Manual of Operations;
• Meet pretreatment eligibility requirements for study enrollment (acceptable medical history and physical examination results);
• Have a parent or legal guardian who is willing to sign the written Informed Consent prior to initiation of any study procedure;
• Are willing to sign the assent form, if age appropriate;
• Have medical insurance at the Screening Visit. Coverage must be in effect from Screening through Enrollment in order to be enrolled.

You may not qualify if:

• Participants who meet any of the following criteria are not eligible for enrollment but may be reassessed. Participants are ineligible if they:
• Have had ≥ 2 life-threatening asthma exacerbations in the last 2 years requiring intubation or mechanical ventilation, or resulting in a hypoxic seizure;
• Are pregnant or lactating. (Females of child-bearing potential must remain abstinent or use a medically acceptable birth control method (e.g. oral, subcutaneous, mechanical, or surgical contraception) throughout the study. This is not for safety, but because it may be difficult to assess asthma control since lung function may change, making it difficult to interpret outcome measures);
• Will not allow the study clinician to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow the protocol;
• Are unable to use a metered-dose inhaler (MDI) for administration of a beta-agonist rescue medication or use a dry powder inhaler (Diskus®) for the administration of asthma controller regimens;
• Are currently receiving hyposensitization therapy or have received hyposensitization therapy to any allergen in the past year prior to recruitment;
• Are currently participating in an asthma-related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to recruitment;
• Do not sleep at least 4 nights per week in the same home;
• Have a sibling or other person living in the same home enrolled in the study;
• Live with a foster parent; not applicable if participant is able to provide consent;
• Do not have access to a phone (needed for scheduling appointments);
• Who are currently taking, or who have taken any of the following medications within 4 weeks of the Screening Visit (Visit -1): Monoamine oxidase inhibitors (phenelzine, tranylcypromine); Tricyclic and tetracyclic antidepressants; beta adrenergic blocker drugs (both oral and topical); Anticonvulsants (carbamazepine, phenobarbital, phenytoin, mephobarbital, primidone, ethosuximide, methsuximide, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproic acid, divalproex sodium, zonisamide); Protease inhibitors (ritonavir, indinavir, nelfinavir); Calcium channel blockers (verapamil, diltiazem); Modafinil; Tamoxifen; non-nucleoside reverse transcriptase inhibitors; Macrolide antibiotics\* (erythromycin, clarithromycin, dirithromycin, troleandomycin); chloramphenicol; nefazodone; aprepitant; St John's Wort; Rifampin\*; Azole Antifungals\* (ketoconazole, fluconazole, itraconazole); Sibutramine\* ; bergamottin (constituent of grapefruit juice) (\*may be rescreened if this therapy is short-lived);
• Should not be included in the study for any other reason, according to the investigator's discretion. This would include when, in the judgment of the investigator, the clinical care of the participant would be compromised by the treatment algorithm;
• Are receiving treatment with omalizumab, or have had omalizumab treatment within three months prior to screening;
• Are not able to perform spirometric pulmonary function tests (PFTs);

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Inner-City Asthma Consortium: collaborator

Study Sites (9)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Henry Ford Health Center

Detroit, Michigan, 48202, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45202, United States

Location

University of Texas Southwestern Medical School

Dallas, Texas, 75390, United States

Location

Related Publications (3)

• Pongracic JA, Krouse RZ, Babineau DC, Zoratti EM, Cohen RT, Wood RA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Kattan M, Teach SJ, Johnson CC, Bacharier LB, Gern JE, Sigelman SM, Gergen PJ, Togias A, Visness CM, Busse WW, Liu AH. Distinguishing characteristics of difficult-to-control asthma in inner-city children and adolescents. J Allergy Clin Immunol. 2016 Oct;138(4):1030-1041. doi: 10.1016/j.jaci.2016.06.059.

  PMID: 27720017 RESULT

• Zoratti EM, Krouse RZ, Babineau DC, Pongracic JA, O'Connor GT, Wood RA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Kattan M, Teach SJ, Sigelman SM, Gergen PJ, Togias A, Visness CM, Busse WW, Liu AH. Asthma phenotypes in inner-city children. J Allergy Clin Immunol. 2016 Oct;138(4):1016-1029. doi: 10.1016/j.jaci.2016.06.061.

  PMID: 27720016 RESULT

• Liu AH, Babineau DC, Krouse RZ, Zoratti EM, Pongracic JA, O'Connor GT, Wood RA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Kattan M, Teach SJ, Makhija M, Pillai D, Lamm CI, Gern JE, Sigelman SM, Gergen PJ, Togias A, Visness CM, Busse WW. Pathways through which asthma risk factors contribute to asthma severity in inner-city children. J Allergy Clin Immunol. 2016 Oct;138(4):1042-1050. doi: 10.1016/j.jaci.2016.06.060.

  PMID: 27720018 RESULT

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)
• Description of Inner-city Asthma Consortium (ICAC)

Biospecimen

Retention: SAMPLES WITH DNA

Participants had the option of having blood, RNA, and DNA stored for use in future research studies.

MeSH Terms

Conditions

Asthma; Rhinitis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Nose Diseases; Otorhinolaryngologic Diseases

Study Officials

• William W. Busse, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 16, 2017

Record last verified: 2017-03

Locations

US (9)