RECRUITING

Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

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Conditions

Moderate to Severe AsthmaAsthma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples. By evaluating response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions, and may ultimately lead to a change in the way that asthma patients are evaluated for potential personalized therapies and maximize the probability that the subject will respond to treatment.

Official Title

Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

Quick Facts

Study Start:2024-02-19
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06385236

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Stated willingness to comply with all study procedures and availability for the duration of the study.
  2. * Stable asthma medications: No change in asthma medications for the past 2 months:
  3. 1. Use of medium or high dose inhaled corticosteroids (ICS) AND
  4. 2. Use of an additional asthma controller medication.
  5. * Baseline poor or uncontrolled asthma.
  6. * Evidence of asthma demonstrated by either bronchodilator reversibility (either at screening or by historical evidence) or methacholine responsiveness (by historical evidence).
  7. * Agreement to adhere to Lifestyle Considerations throughout study duration.
  1. * Current participation in an interventional trial (e.g. drugs, diets, etc.).
  2. * Currently on an asthma biologic or having been on biologic within 3 months of screening.
  3. * Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater).
  4. * Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways.
  5. * Receiving one or more immune-modulating therapies for diseases other than asthma. This includes biologics that are also approved for asthma.
  6. * Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®).
  7. * Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy.
  8. * Underwent a bronchial thermoplasty within the last two years.
  9. * Born before 30 weeks of gestation.
  10. * Uncontrolled hypertension, defined as systolic blood pressure \> 160 mm/Hg or diastolic blood pressure \> 100 mm/Hg.
  11. * History of malignancy except non-melanoma skin cancer within the last five years.
  12. * History of smoking:
  13. 1. If \<45 years old: Smoked for ≥5 pack-years\*
  14. 2. If ≥45 years old: Smoked ≥ 10 pack years.
  15. * Active use of any inhalant \>1 time per month in the past year.
  16. * Substance abuse within the last year.
  17. * Unwillingness to practice medically acceptable birth control or complete abstinence during the study, current pregnancy, or lactation.
  18. * Requirement for daily systemic corticosteroids at the time of screening.
  19. * Respiratory infection within 1 month of screening.
  20. * Intubation for asthma in the last 12 months.
  21. * Any clinically significant abnormal findings in the history, physical examination, vital signs, electrocardiogram, hematology or clinical chemistry during run-in period, which in the opinion of the site investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
  22. * BMI \> 38.
  23. * Allergic to any of the drugs, biologics or chemicals used in this study.

Contacts and Locations

Study Contact

Clinical Trial Operations and Data Management Specialist UA-DCC
CONTACT
520-626-9552
bio5-epiphanydcc@arizona.edu

Principal Investigator

Kelan Tantisira, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

Mayo Clinic
Scottsdale, Arizona, 85259
United States
University of California, San Diego
La Jolla, California, 92093
United States
Yale University
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Kelan Tantisira, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-19
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2024-02-19
Study Completion Date2028-01-31

Terms related to this study

Keywords Provided by Researchers

  • Asthma

Additional Relevant MeSH Terms

  • Moderate to Severe Asthma