Asthma Phenotypes in the Inner City (APIC)

This study has been completed.
Sponsor:
Collaborator:
Inner-City Asthma Consortium
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01383941
First received: June 27, 2011
Last updated: November 5, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Asthma
Rhinitis
Drug: Guidelines-based asthma and rhinitis/rhinosinusitis therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Asthma Phenotypes in the Inner City (ICAC-19)

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

Primary Outcome Measures:
  • Phenotypic Identification: Discriminating Difficult-to-Treat from Easy-to-Treat Asthmatics In a Study Cohort [ Time Frame: Baseline through 12 months of standardized asthma and rhinitis treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Identification of Asthma Phenotypes [ Time Frame: Baseline through 12 months of standardized asthma and rhinitis treatment ] [ Designated as safety issue: No ]
    Using cluster analysis techniques

  • Identification of Rhinitis Phenotypes [ Time Frame: Baseline through 12 months of standardized asthma and rhinitis treatment ] [ Designated as safety issue: No ]
    Using cluster analysis techniques


Biospecimen Retention:   Samples With DNA
Participants had the option of having blood, RNA, and DNA stored for use in future research studies.

Enrollment: 717
Study Start Date: August 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.
Other Names:
  • asthma controller medications
  • rhinitis/rhinosinusitis controller medications

Detailed Description:

Asthma is a complex, heritable disease that affects more than 11.2% of the U.S. population, which represents approximately 9 million children and 23 million adults. Although the underlying characteristics of asthma exist in virtually all patients, the clinical expression of the disease and response to treatment are highly variable.

The purpose of this study is to identify characteristics that will discriminate Difficult-to-Treat from Easy-to-Treat asthma in a defined inner-city population adherent to study-directed asthma treatment and management.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Inner-city Asthma Consortium (ICAC) children with mild to severe asthma
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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);
  • Are not adherent to the controller medication between Visit 1 and Visit 0 (defined as medication use less than 50%, (Ref: Section 6.6 in study protocol- determining treatment adherence);
  • Participants who meet any of the following criteria are not eligible for enrollment and may not be reassessed. Participants are ineligible if they:

    • Do not primarily speak English (or Spanish at centers with Spanish speaking staff). Exclusion also applies to the child's caretaker;
    • Plan to move from the area during the study period (13 months);
    • Have any medical illnesses that in the opinion of the investigators would a.) increase the risk the subject would incur by participating in the study; b.) interfere with the measured outcomes of the study; or c.) interfere with the performance of the study procedures.

Examples of such diseases are: phenylketonuria, cystic fibrosis, bronchiectasis, type 1 diabetes, hemophilia, Von Willebrand disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E syndrome, parasite infection(s), Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis;

  • Have known hypersensitivity to any of the medications that will be used for the treatment of asthma or rhinitis;
  • Have a current, severe hypersensitivity to milk;
  • Have a current diagnosis of cancer, are currently being investigated for possible cancer, or who have a history of cancer.
  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: NCT01383941

Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, District of Columbia
Children's National Medical Center
Washington, 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, 21287
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, Michigan
Henry Ford Health Center
Detroit, Michigan, United States, 48202
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45202
United States, Texas
University of Texas Southwestern Medical School
Dallas, Texas, United States, 75390
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Inner-City Asthma Consortium
Investigators
Study Chair: William W. Busse, MD University of Wisconsin, Madison
  More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01383941     History of Changes
Other Study ID Numbers: DAIT ICAC-19 
Study First Received: June 27, 2011
Last Updated: November 5, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
asthma
rhinitis
difficult-to-treat asthmatic
phenotypes

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 26, 2016