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CLINICAL RESEARCH - Asthma Allergy

Upcoming Studies

Below please find the list of our upcoming Studies:

TBI-001-IGIV– A prospective, open-label, multicenter study of the efficacy, safety, tolerability, and Pharmacokinetics of Therapure PlasmaCap IG in Adults and Children with Primary Immune Deficiency Diseases. A Phase 3 trial, duration 1 year.

Quick Glance on Inclusion/Exclusion Criteria(s) ↓

  • Age, 2-70 years of old
  • Confirmed diagnosis of a PIDD which requires treatment with IGIV.
  • Hyper-IgM Syndrome (HIGM) with documented IgG levels < 500 mg/dL
  • Must have received IGIV therapy at 21 or 28 days intervals for at least three consecutive months at a stable dose between 300-900 mg/kg/infusion (without having a ≥ 25% change in dose) prior to screening
  • No bacterial infection or viral infection within 7 days prior to baseline or is receiving antibiotic treatment
  • No secondary immunodeficiency
  • Subject must have not received IMP under investigation within the past 30 days at the time of baseline
  • NO positive NAT, HIV -1 or HIV-2, Hepatitis B (HBV) and C (HCV), Anemia 3 times the ULN
  • eGFR must be >60
  • Must have not received other immunosuppressive or immunomodulatory drugs or chemotherapy
  • No Prednisone within 10 days prior to screening

(Starts ~ June 2017)

D3250C00045– A multicenter, randomized, double-blind, and parallel group, placebo-controlled, Phase 3 study to evaluate the safety and efficacy of Benralizumab 30 mg SC in patients with Severe Asthma uncontrolled on standard of care treatment. 28 week trial.

Quick Glance on Inclusion/Exclusion Criteria(s) ↓

  • Age, 18-75 years old
  • Physician diagnosed asthma requiring treatment with medium to high dose ICS plus asthma controller for at least 12 months prior to screening
  • Stable dose for at least 3 months prior to screening
  • History of at least 2 asthma exacerbations while on ICS plus another asthma controller that treatment with systemic corticosteroids in the 12 months prior to screening
  • Pre-bronchodilator FEV of <80% predicted at visit 2
  • No clinically important pulmonary disease other than asthma
  • No Acute upper or lower respiratory infections within 30 days prior to screening
  • Asthma treatment not allowed: Xolair or Nucala

(Starts ~ June 2017)

PT001103– A randomized, double-blind, parallel group, multi-center 12 week study comparing the efficacy and safety of three doses of PT001 to placebo in subjects with persistent asthma. Phase III, duration 4.5 months.

Quick Glance on Inclusion/Exclusion Criteria(s) ↓

  • Age, 12-80 years of age
  • Documented physician diagnosed asthma
  • Required inhaled asthma maintenance therapy; has been using an ICS/LABA with the ICS doses allowed for at least 3 months and on a stable regimen for 4 weeks prior to screening
  • Pre-albuterol FEV of <80% predicted normal value
  • Demonstrate acceptable MDI administration technique. •No spacer device is allowed•
  • BMI must be 6 months prior to screening
  • No hospitalization for asthma within 3 months.
  • Cancer remission >5 years
  • No treatment with IMP or device within 30 days

(Starts: ~ July 2017)

ACT-2016-001-0AA– A randomized, blinded, parallel group, placebo controlled, multicenter study to compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg to Flovent HFA 110 mcg , in Adolescent and Adult patients with Asthma.

Quick Glance on Inclusion/Exclusion Criteria(s) ↓

  • ≥ 12 years of age
  • Diagnosed with asthma at least 12 weeks prior to screening
  • Pre-bronchodilator FEV ≥ 40% and 85% ≤ predicated value at screening
  • Patient should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to screening
  • Must be only using short-acting B agonist (SABA) to control asthma symptoms (> 2x wk)
  • No IMP within 3 months prior to screening
  • Non-smokers only
  • Able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits (12 hours before screening visit)
  • Able to replace current SABAs with albuterol/salbutamol inhaler (ie, Ventolin or ProAir) for use as needed for the duration of the study
  • Able to discontinue current asthma medications (inhaled corticosteroids, LABA) during the Run-in period and for remainder of the study
  • No history of life-threatening asthma, or significant respiratory disease other than asthma (eg, chronic obstructive pulmonary disease, interstitial lung disease

(Starts ~July 2017)

Fall SAR- A randomized, multiple-dose, placebo controlled, parallel group dosing, Bioequivalence study evaluating the safety and efficacy of a test product to a reference product in the treatment of Fall Seasonal Allergic Rhinitis.

Quick Glance on Inclusion/Exclusion Criteria(s) ↓

  • Age 12 years of age or older
  • Documented positive allergic skin test, performed within the previous 12 months to the allergen in season at the time the study is being conducted\
  • A minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted
  • No patients with nasal conditions, including infectious rhinitis, rhinitis medicamentosa or atrophic rhinitis
  • No nasal infection within the previous 30 days or history of reoccurring sinus infections
  • No Upper respiratory tract infection within the previous 30 days

(Starts~ August 2017)

GA39688– A Phase III, randomized, multicenter double-blind, placebo-controlled clinical trial of Omalizumab (Xolair) in patients with Chronic Rhinosinusitis with Nasal Polyps.
It is a 1:1 ratio (Xolair: Placebo) for a period of 34 weeks.

Quick Glance on Inclusion/Exclusion Criteria(s) ↓

  • Age 18-75 years of age
  • Must be on treatment with nasal mometasone 200 ug twice a day, or equivalent daily dosing of nasal CS for at least 4 weeks before screening
  • Presence of nasal blockage/congestion with NCS ≥ 1 with at least one of the following symptoms prior to screening: nasal discharge (anterior or posterior
  • nasal drip) and/or reduction or loss of smell
  • IgE level must be ≥30 to ≤ 1500 IU/mL and body weight ≥30 to ≤ 150 kg
  • No history of anaphylaxis/hypersensitivity to Omalizumab
  • No treatment with investigational drugs within 12 weeks prior to screening
  • No usage of systemic CS during the run-in period
  • Treatment with > 1000 ug/day fluticasone or an equivalent inhaled CS for asthma (at any point in the 3 months prior to screening) or a history of ≥ 2 Asthma exacerbations within the last 12 months requiring systemic (oral and/or parenteral) CS treatment, emergency room visit, or hospitalization
  • Must not have receipt of intranasal CS drops or CS-administering devices (eg, OptiNose device or stents) within 1 month prior to screening

(Starts ~ August 2017)