Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:6 - 17
Updated:2/22/2018
Start Date:October 2015
End Date:January 2017

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Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy: A Systems Approach Phase 1 (ICAC-29)

Asthma is a growing problem, especially in children. It causes frequent wheezing, shortness
of breath, chest tightness, and cough. A cold that is caused by a virus (viral cold) can
sometimes make asthma symptoms worse. This study will help investigators learn about the way
colds are related to asthma attacks among children who need higher amounts of medications to
control their asthma. Investigators want to learn why viral colds sometimes cause asthma
attacks and other times do not by studying the immune system response in samples taken from
the nose and blood.

This study is a prospective, longitudinal, nested case-control study designed to identify
changes in gene transcription predictive of and associated with asthma exacerbations in
children ages 6 to 17 years with difficult-to-control, exacerbation-prone asthma.

Participants will be followed prospectively for the onset of a cold and a subsequent asthma
exacerbation. An internet-based asthma and cold symptom diary will be accessed by
participants using a hand-held device. When the participant reports development of a cold, a
clinic visit will be scheduled as soon as possible (within 48 hours of cold symptom onset) to
collect blood and nasal samples. A second clinic visit will occur 4-6 days from the onset of
cold symptoms to obtain samples after the initial cold, but prior to the use of systemic
corticosteroids. Participants will be followed for up to two colds or approximately 6 months
after Visit 0, whichever comes first.

Inclusion Criteria:

Participant(s) who meet all of the following criteria are eligible for enrollment.
Participant(s) may be reassessed if not initially eligible. Participants are eligible if
they:

- Have a primary place of residence in one of the pre-selected recruitment census tracts
as outlined in the Inner City Asthma Consortium (ICAC) Manual of Procedures (MOP);

- Have a diagnosis of asthma made by a clinician >1 year prior to recruitment;

- Have had at least 2 asthma exacerbations in the prior year, defined as a requirement
for systemic corticosteroids and/or hospitalization;

- Have the following requirement for asthma controller medication at the Screening and
Enrollment Visit (Visit 0) according to the MEDS program[4, 2]:

- For participants aged 6 to 11 years, treatment with at least fluticasone 250 mcg
1 puff twice daily or its equivalent;

- For participants ages12 years and older, treatment with at least Advair 250/50
mcg 1 puff twice daily or its equivalent.

- Have peripheral blood eosinophils >=150 per mm^3. Results can be obtained from
participation in a previous ICAC study if obtained within 6 months of the Screening
and Enrollment Visit (Visit 0);

- Currently a non-smoker;

- Parent/legal guardian is willing to sign the written informed consent;

- Participant is willing to sign the assent form as per central Institutional Review
Board (IRB) guidelines;

- Has some form of insurance that covers costs of usual care asthma control and rescue
medications at the Screening and Enrollment Visit (Visit 0).

Exclusion Criteria:

Participant(s) who meet any of the following criteria are not eligible for enrollment but
may be reassessed. Participant(s) are ineligible if they:

- Are currently pregnant or lactating;

- Are currently receiving treatment with anti-immunoglobulin E (anti-IgE) therapy or
have had anti-IgE therapy in the previous 3 months prior to screening;

- Are currently receiving immunotherapy;

- Have clinically significant abnormalities on complete blood count (CBC) with
differential as determined by the site study clinician. Results can be obtained from
participation in a previous ICAC study [including Registry for Asthma Characterization
and Recruitment 2 (RACR2), NCT02513264} if obtained within the last 6 months of Visit
0;

- Was treated with systemic corticosteroids for any medical condition including an
asthma exacerbation within the 2 weeks prior to Visit 0;

- Have had a cold in the previous 7 days;

- Are currently participating in an asthma-related pharmaceutical study or intervention
study or has participated in another asthma-related pharmaceutical study or
intervention study in the previous 4 weeks prior to recruitment;

- Are currently requiring greater than fluticasone 500 mcg bid plus long-acting beta
agonist (LABA) 1 puff twice daily or its equivalent and\or individuals using oral
corticosteroids daily or every other day at Visit 0.

Participants who meet any of the following criteria are not eligible for enrollment and may
not be reassessed. Participants are ineligible if they:

- Have any medical illnesses that in the opinion of the investigators would a.) increase
the risk the participant 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 Willebrands disease, sickle cell
disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E
syndrome, parasite infections, Wiskott-Aldrich syndrome, or allergic bronchopulmonary
aspergillosis.

- Have concurrent medical problems that would require systemic corticosteroids (other
than for treatment of an asthma exacerbation) or other immunomodulators during the
study;

- Currently have diagnosed cancer, are currently being investigated for possible cancer,
or have a history of cancer;

- Have plans to move from the area during the study period;

- Do not primarily speak English (or Spanish at clinical sites with Spanish speaking
staff);

- Have a primary caretaker who does not speak English (or Spanish at clinical sites with
Spanish-speaking staff; not applicable if participant is able to provide consent);

- Are a foster child;

- Will not allow the study clinician to manage their disease for the duration of the
study or are not willing to change their asthma medications to follow the protocol;

- Are not able to perform pulmonary function tests;

- Have known hypersensitivity to any of the medications that will be used for the
treatment of asthma;

- Have had a life-threatening asthma exacerbation in the last 2 years requiring
intubation, mechanical ventilation, or resulting in a hypoxic seizure.
We found this trial at
9
sites
72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Principal Investigator: George O'Connor, MD
Phone: 617-414-3263
Boston University School of Medicine A leader in medical education and research, Boston University School...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Andrew Liu, MD
Phone: 720-777-5379
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Chicago, Illinois 60614
Principal Investigator: Jacqueline Pongracic, MD
Phone: 312-227-6454
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Cincinnati, Ohio 45229
Principal Investigator: Carolyn Kercsmar, MD
Phone: 513-636-4894
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Rebecca Gruchalla, MD
Phone: 214-648-2620
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Detroit, Michigan 48202
Principal Investigator: Edward Zoratti, MD
Phone: 313-874-5476
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Detroit, MI
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Meyer Kattan, MD
Phone: 212-305-6255
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Saint Louis, Missouri 63110
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Saint Louis, MO
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Stephen Teach, MD
Phone: 202-476-4698
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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