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AsthmaMUPPITS-1NCT02502890

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

An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Asthma
How many people
208 participants
Where
9 sitesUnited States
Study dates
Oct 2015to Jan 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: 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.

Who may be able to join

  • 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;
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  • 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).

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

  • Ann and Robert Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Columbia University Medical Center

    New York, New York, 10032

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Asthma
Keywords
asthma, nested case-control study, difficult-to-control asthma, asthma exacerbations, cold symptoms, gene expression
Medical subject headings
Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gene expression of nasal lavage RNA samples.

    Gene expression will be measured by whole transcriptome RNA sequencing.

    Measured: 6 month

Secondary outcomes (1)

  1. Gene expression of whole blood RNA samples

    Gene expression will be measured by whole transcriptome RNA sequencing

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02502890
Sponsor's protocol ID
DAIT ICAC-29
Acronym
MUPPITS-1
Status last verified
Feb 2018
First submitted
16 Jul 2015
Last updated
20 Feb 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gene expression of nasal lavage RNA samples. (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02502890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.

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