Primary Objectives: (1) Identify novel therapies that work in biomarker-defined subgroups of severe asthmatic participants; (2) Optimize the subgroups targeted for treatment by refining the biomarkers and subgroup definitions. Secondary Objectives: (1) Gain information about potential response/pharmacodynamics biomarkers for selected therapies; (2) Explore the safety and effectiveness of selected therapies in adolescent participants with severe asthma.
PrecISE: A breath of fresh air from the National Institutes of Health (NIH). Severe asthma is different for everyone. That is why we need you for PrecISE. Join a severe asthma study unlike any other. Have the opportunity to try many different therapies not available otherwise. Talk with an asthma specialist and be compensated for your time. If you choose, you can receive study provided baseline asthma therapies and asthma controller medication. Multiple treatments will be tested in a placebo controlled randomized trial. In this (12-18) age group, interventions include MCT supplement and Broncho-Vaxom. Each participant will participate in at least 2 treatment periods (up to 5 treatment periods). Treatment periods will each last 16 weeks and will require monthly visits.More
You/Your patients may qualify for this first of its kind study if they: **Are age 12 and up. **Have severe asthma as defined by commonly accepted guidelines. **Currently have uncontrolled asthma, or worsening asthma & attacks. **Are on a stable regimen of asthma medications. **Are not pregnant and not breastfeeding. **Are not taking part in other clinical trials.
Detailed Eligibility: For Providers: I. Inclusion Criteria: 1). 12 years of age and older 2). no change in asthma medications for the past 2 months and use of medium or high dose inhaled corticosteroids + an additional asthma controller/biologic 3). Baseline poor or uncontrolled asthma defined by: o FEV1 <80% predicted (adults over 18yrs) or FEV1 <90% (pediatric patients <18yrs) AND with 12% reversibility o Greater than or equal to 1 exacerbation, documented burst of systemic corticosteroids in prior year o Evidence of asthma by either bronchodilator reversibility or methacholine responsiveness II. Exclusion Criteria: 1). Receiving one or more immune-modulating therapies for disease other than asthma 2). < 35 weeks of gestation age 3). Requirement for daily systemic corticosteroids above 10 mg or prednisone (or equivalent) per day for the past 2 months 4).other chronic lung conditions or chronic medical conditions
II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Childrens Hospital Colorado
Stanley Szefler, MD
Protocol Number: 19-0619
More information available at ClinicalTrials.gov: NCT04129931
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