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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.

SANOFI- ATLAS (LUNG FUNCTION DECLINE) ADULT

> 18 YEARS OLD. {ASTHMA STUDY}

  •  The investigational medicinal product will be Dupilumab, or matching placebo supplied in a prefilled syringe to deliver 300 mg in a 2mL injection. Loading dose of 600mg at first dose, then 300mg given Q 2 weeks.
  • The purpose of the study is to assess the effect of Dupilumab on preventing or slowing the rate of lung function decline, (Rate of change to week 52 on post-BD FEV1 slope).
  • Duration: Screening and run-in period up to 4 weeks, followed by a 3-year double blind treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

Key Inclusion Criteria:

  • Participant will need to have been diagnosed with asthma (according to GINA 2020) for > 12 months and treated with medium to high dose ICS in combination with a second controller (e.g., LABA, LTRA) for at least 3 months with stable dose > 1month prior to visit 1.
  • History of > 1 exacerbation(s) in the previous year before V1.

Key Exclusion:

  • History or clinical evidence of COPD including Asthma-COPD Overlap. Known or suspected immunodeficiency. Treatment with oral corticosteroids (OCS) for more than 2 weeks before V1.
  • Current smoker (cigarette or e-cigarette) or cessation of smoking within 6 months to visit 1 OR previous smoker with > 10 pack year smoking history.

AstraZeneca (AIRSUPRA)  18 YEARS OF AGE. {ASTHMA STUDY}

  • Equivalence of Budesonide and Albuterol (BDA) Delivered by MDI HFO Compared with BDA Delivered by MDI HFA in Participants with Asthma
  • 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: 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.

Key inclusion:

  • ≥ 18 years of age
  • Bronchodilator responsiveness to albuterol is defined as a > 12% and > 200 mL increase in FEV1 relative to baseline following administration of albuterol.
  • Participants who have physician diagnosed asthma as defined by GINA (GINA, 2023) for at least 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.

Key Exclusion:

  • Diagnosis of COPD
  • Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months prior to Visit 1

REGENERON (AIM4) ADULTS AND ADOLESENTS 12-80 YEARS OF AGE. {ASTHMA STUDY}

  • Randomly chosen to receive one of 2 study treatments:
    • Dupilumab and the same inhaler you received
    • Placebo injection and a higher dose of the asthma inhaler you received during the run-in period
  • 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).
    9- will be clinical visits and 9 will be phone call visits.

Key inclusion:

  • Diagnosis of asthma for ≥12 months, Existing treatment with medium dose ICS/LABA (>250 to 500 μg/day of fluticasonepropionate 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.

Key Exclusion:

  • A participant with a diagnosis of COPD or other lung diseases.
  • Weight is less than 30 kilograms
  • Current smoker or cessation of smoking within 6 months prior to visit 1. Previous smokers with a smoking history ≥10 pack-years.
  • Treatment with any biologic therapy/immunosuppressant/immunomodulator (including
    dupilumab) within 6 months.

ASTRAZENECA (FLASH) 18 – 88 YEARS OF AGE {ASTHMA STUDY}

  • Atuliflapon, is an oral selective FLAP inhibitor being developed for the treatment of asthma. Five-lipoxygenase activating protein (FLAP) is part of the 5-LO pathway that generates biologically active lipid mediators called leukotrienes.
  • 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.

Key Inclusion:

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

Key Exclusion:

  • Current smokers or participants with smoking history ≥ 10 pack-years.
  • Treatment with marketed biologics including benralizumab, mepolizumab, reslizumab, omalizumab, and dupilumab within 6 months of Screening (Visit 1) or 5 half-lives

AMGEN (ROCATINLIMAB) 18 - 75 YEARS OF AGE {ASTHMA STUDY}

  • Rocatinlimab is a monoclonal antibody that targets OX40 and has a dual mechanism of action including blocking OX40-OX40L interaction and reducing the number of OX40 expressing T-cells through ADCC.
  • 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.

Key Inclusion:

  • 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

Key Exclusion:

  • Chronic Obstructive Pulmonary Disease (COPD
  • Current smoker, including active vaping of any products and/or marijuana, or former smoker with cessation within 6 months of screening, or history of > 10 pack-years.

ASTRAZENECA (ANCHOR) ADULTS AGED 18 AND ABOVE {ASTHMA STUDY}

  • The product being studied, AIRSUPRA (albuterol and budesonide) inhalation aerosol for oral inhalation use.
  • The purpose of the study: Assessment of Combination Short-Acting Bronchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care”
  • Study duration: participants are expected to take part in this study for approximately twelve (12) months.

Key inclusion:

  • At least 1 diagnosis of asthma prior to the enrollment date documented in patient record
  • At least 1 severe asthma exacerbation within 12 months before enrollment date.
  • At least 1 prescription filled for SABA-only inhaler (i.e., albuterol-only or levalbuterol-only inhalers) within 12 months before enrollment date.

Key Exclusion:

  • Conditions with major respiratory diagnoses including COPD.
  • Chronic use of oral corticosteroids (for any condition) within 3 months before enrollment date.
  • History of AIRSUPRA use within 12 months before enrollment date.

NOVARTIS (RECLAIM) AGE Greater than 18 YEARS AND OLDER (CSU STUDY)

  • The purpose of the study is to evaluate the efficacy of remibrutinib when compared to dupilumab at early timepoints in adults with chronic spontaneous urticaria inadequately controlled by second generation H1-antihistamines.
  • Remibrutinib is a low molecular weight compound for oral administration that covalently binds and inhibits BTK (Bruton’s tyrosine kinase (BTK).
  • Dupilumab is a fully human monoclonal antibody directed against the shared IL-4 receptor subunit α of IL-4 and IL-13 receptors.
  • Duration: 24 weeks.

Key Inclusion:

  • CSU duration for ≥ 6 months prior to screening
  • Documentation of hives within three months before randomization
  • Male and female adult participants ≥ 18 years of age

Key Exclusion:

  • Previous use of dupilumab (Dupixent).
  • Sole trigger of their chronic urticaria (i.e., chronic inducible urticaria), including symptomatic dermographism.
  • Any other skin disease associated with chronic itching that might influence, in the investigator’s opinion, the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis.

Interested in hearing more about these Research Trials?

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