Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
Recruiting
Phase 4Interventional Study
Moderate to Severe Asthma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
University of California, San Diego · Other
Who this trial is looking for
This trial is looking for adults with uncontrolled asthma who have been on stable asthma medications for at least two months. To participate, you shouldn't be on any biologic treatments for asthma or have certain other lung conditions. Also, if you've had any serious health issues recently or a history of significant smoking, you won't be eligible.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 a…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Stable asthma medications: No change in asthma medications for the past 2 months:
1. Use of medium or high dose inhaled corticosteroids (ICS) AND
2. Use of an addition…
Inclusion Criteria:
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Stable asthma medications: No change in asthma medications for the past 2 months:
1. Use of medium or high dose inhaled corticosteroids (ICS) AND
2. Use of an additional asthma controller medication.
* Baseline poor or uncontrolled asthma.
* Evidence of asthma demonstrated by either bronchodilator reversibility (either at screening or by historical evidence) or methacholine responsiveness (by historical evidence).
* Agreement to adhere to Lifestyle Considerations throughout study duration.
Exclusion Criteria:
* Current participation in an interventional trial (e.g. drugs, diets, etc.).
* Currently on an asthma biologic or having been on biologic within 3 months of screening.
* Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater).
* 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.
* Receiving one or more immune-modulating therapies for diseases other than asthma. This includes biologics that are also approved for asthma.
* Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®).
* Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy.
* Underwent a bronchial thermoplasty within the last two years.
* Born before 30 weeks of gestation.
* Uncontrolled hypertension, defined as systolic blood pressure \> 160 mm/Hg or diastolic blood pressure \> 100 mm/Hg.
* History of malignancy except non-melanoma skin cancer within the last five years.
* History of smoking:
1. If \<45 years old: Smoked for ≥5 pack-years\*
2. If ≥45 years old: Smoked ≥ 10 pack years.
* Active use of any inhalant \>1 time per month in the past year.
* Substance abuse within the last year.
* Unwillingness to practice medically acceptable birth control or complete abstinence during the study, current pregnancy, or lactation.
* Requirement for daily systemic corticosteroids at the time of screening.
* Respiratory infection within 1 month of screening.
* Intubation for asthma in the last 12 months.
* 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.
* BMI \> 38.
* Allergic to any of the drugs, biologics or chemicals used in this study.
Contacts
Clinical Trial Operations and Data Management Specialist UA-DCC
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