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Current Research Studies

The Family Allergy & Asthma Research Institute is currently recruiting individuals who have allergic and asthmatic conditions for our active studies listed below. You do not need to be a current patient of Family Allergy & Asthma to participate in a research study.

If you are interested in participating and believe you meet the requirements, please contact our research staff to learn more at 502.368.0732.

ALK PT-03 (PEANUT ALLERGY)

  •  A phase I/II trial in 3 parts assessing the safety, tolerability, and efficacy of a once-daily peanut sublingual immunotherapy (SLIT) tablet in adults, adolescents, and children with peanut allergy. Part 1 and Part 2 have been completed.
  •  The doses for part 3 were selected by the sponsor from the doses tested in part 2 based on the clinical safety and tolerability assessment
  • The purpose of the study is to evaluate the effect of two maintenance doses of the peanut SLIT-tablet compared with placebo on tolerated dose (TD)-600 response after 24 weeks of maintenance treatment.
  • All subjects must undergo a screening DBPCFC prior to enrollment to confirm and assess clinical allergy to peanut allergen. Subjects participating in part 3 will also undergo an exit DBPCFC for the assessment of efficacy after 24 weeks maintenance treatment.
Eligibility:
  • Part 3: Male or female aged 4 through 65 years (inclusive) on the day of randomization
  • Subject must have a documented clinical history of an IgE-mediated allergic reaction towards peanut-containing food.
  • Subjects must not have had a history of severe or life-threatening episodes of anaphylaxis or anaphylactic shock within 60 days of the screening DBPCFC.

OCTOPHARMA NORM-01 (PID)

  • The study will assess the efficacy of Newnorm in preventing serious bacterial infections in patients with Primary Immunodeficiency.

Eligibility:

  • Age > 12 years and < 75 years. Documented confirmed diagnosis of PID. At least 12-weeks of regular treatment before the screening visit.
  • Bass mass index must be > 40 kg.
  • Duration of study is 52 weeks. Subject will be provided with study product and supplies for infusions at home, when not completed at the study site.
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  •  The primary objective of the study is to assess the effect of Dupilumab on preventing or slowing the rate of lung function decline .
  • The investigational medicinal product will be Dupilumab, or matching placebo supplied in a prefilled syringe to deliver 300 mg in a 2mL injection.
  • Dose regimen: every 2 weeks (Q2W) after initial loading dose of 600 mg (2 injections of 300 mg) on Day 1, given subcutaneous (SC).
  • Duration of study: Screening and run-in period up to 4 weeks, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

Eligibility

  • Participant will need to have been diagnosed with asthma (according to GINA 2020) for > 12 months and treated with medium to high dose ICS (inhaled corticosteroid) in combination with a second controller (e.g., LABA (long-acting beta agonist), LTRA (leukotriene receptor antagonists) for at least 3 months with stable dose > 1month prior to visit 1.  Additionally, need a History of > 1 exacerbation(s) in the previous year before Visit 1.

GSK (SALBUTAMOL) ≥ 18 YEARS OF AGE

  •  The purpose of the study is to assess and compare safety and tolerability of 3 months treatment with salbutamol administered via MDI containing propellant HFA-152a or HFA‑134a in participants ≥ 18 years of age with asthma.
  • In the course of 3 months, subjects will attend 5 on-treatment visits at Visits 3,4,6,7, and 8 (Weeks 0, 1, 4, 8, and 12 respectively). Visit 5 and Week 2 will be a virtual/telephonic visit. Subjects will receive enough treatment for 3 months of dosing over the course of the study.

Eligibility:

  • Participant must be ≥ 18 years of age
  • Asthma for ≥ 6 months
  • Stable dose of asthma maintenance treatment, for at least 12 weeks prior to the screening visit.

ASTRAZENECA (PROPELLANT) ≥ 18 YEARS OF AGE

  • This study will assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant, HFO, compared with BDA delivered using the currently approved propellant, HFA, in participants with asthma.
  • Duration of study: Approximately 14 to 15 weeks. A screening and placebo run-in period of 2 weeks prior to the first dose of study intervention. 3 treatment periods of 4 weeks each. A final safety follow-up visit via telephone contact approximately 5 days after the final dose of study intervention.

Eligibility

  • Participant must be ≥ 18 years of age
  • Participant will need to have been diagnosed with asthma (according to GINA 2023) for ≥ 12 months prior to Visit 1.
  • Eligible participants are on either a) no daily inhaled maintenance therapy or b) daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA
  • Participants who are on low-dose ICS maintenance therapy are required to be stable on therapy for a minimum of 3 months prior to Visit 1; participants using low-dose ICS-LABA maintenance regimens are required to be stable on therapy for a minimum of 6 months prior to Visit 1.

REGENERON (AIM4) ADULTS AND ADOLESCENTS 12-80 YEARS OF AGE

  •  The purpose of the study is to evaluate the efficacy of dupilumab added to medium dose ICS/LABA in reducing severe asthma exacerbations in comparison to ICS dose escalation to high dose ICS-LABA in participants with uncontrolled asthma.
  • The duration of the study for a participant is approximately 58 weeks. The study is comprised of 3 periods: a screening period (2±1 weeks), a run in period (4+1 weeks), and a treatment period (52 weeks ± days).

Eligibility:

  • Diagnosis of asthma for ≥ 12 months
  • Existing treatment with medium dose ICS/LABA (>250 to 500 μg/day of fluticasone propionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 months.
  • History of ≥1 severe exacerbation(s) in the previous year before visit 1.

ASTRAZENECA (FLASH) ≥ 18 YEARS OF AGE

  •  The purpose of this study is to assess the efficacy and safety of Multiple dose levels of Atuliflapon Given Orally Once Daily for twelve Weeks in Adults with Moderate to Severe Uncontrolled Asthma.
    • Part 1 and Part 2: The overall study period is approximately 19 weeks; a 2-week Screening period, a 4-week run-in period, a 12-week treatment period, and a 1-week follow-up.

Eligibility

  • Participant must be 18 to 80 years of age
  • Body weight ≥ 40 kg and BMI < 35 kg/m2
  • Documented physician-diagnosed asthma ≥ 12 months prior to Screening (Visit 1).

AMGEN (ROCATINLIMAB) 18 - 75 YEARS OF AGE

  • The purpose of the study is to describe the efficacy Rocatinlimab in reducing exacerbations.
  • Duration: The maximum study duration for a single subject will be up to 62 weeks, including a screening period of up to 2 weeks, a run-in baseline period of 4 weeks (during which adherence to stable background therapy and daily diary use will be monitored), a 48-week blinded treatment period, and a SFU visit approximately 16 weeks after the last dose of investigational product. All subjects will be dosed every 4 to 8 weeks with either rocatinlimab or placebo to maintain blind.

Eligibility:

    • Subjects must be between the ages of 18 and 75 inclusive
    • Asthma was diagnosed by a physician for ≥ 12 months prior to the screening visit
    • Documented history of ≥ 1 asthma exacerbation in the past year

Interested in hearing more about these Research Trials?

Please contact one of our staff at 502.368.0732 or fill out the form below:

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