Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy
MUPPITS-1
1 other identifier
observational
208
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2015
CompletedFirst Posted
Study publicly available on registry
July 20, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFebruary 20, 2018
February 1, 2018
1.3 years
July 16, 2015
February 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gene expression of nasal lavage RNA samples.
Gene expression will be measured by whole transcriptome RNA sequencing.
6 month
Secondary Outcomes (1)
Gene expression of whole blood RNA samples
6 month
Eligibility Criteria
The MUPPITS study will enroll inner-city children 6-17 years of age with difficult-to-control, exacerbation-prone asthma. Approximately 150 children will be enrolled and followed prospectively.
You may qualify if:
- 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).
You may not qualify if:
- 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);
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Links
Biospecimen
Blood, Nasal Samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel J Jackson, MD
University of Wisconsin, Madison
- STUDY CHAIR
Matthew C Altman, MD, MPhil
Benaroya Research Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2015
First Posted
July 20, 2015
Study Start
October 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
February 20, 2018
Record last verified: 2018-02