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CLINICAL RESEARCH - Asthma Allergy

Upcoming Studies

Below please find the list of our upcoming Studies:

Disease Major Inc / Criteria Major Exclusions Study Title
Severe Asthma * Age – 18 – 75
* High dose ICS plus asthmas controller for at least 12 months prior to screening
* History of at least 2 asthma exacerbations while on ICS plus another asthma controller that requires treatment with systemic corticosteroids in the 12 months prior to screening
* Pre-bronchodilator FEV of <80% predicted at visit 2 and reversibility ≥ 12%
* Eosinophil count must be ≥ 300 cells/uL
* 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
A multicenter, Randomized, Double-Blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30mg SC in patients with Severe Asthma Uncontrolled on Standard of Care Treatment.
Study Name Disease Major Inc / Criteria Major Exclusions Study Title
GA39855 (Polyp 2) Chronic Rhinosinusitis with Nasal Polyps * Must be age 18 – 75 years of age
* Must have NPS≥5. with a unilateral score of ≥2 for each nostril at screening- central panel readers
* Must be on treatment with nasal mometasone 200ug twice a day, or equivalent daily dosing of nasal CS for at least 4 weeks before screening
* Must have 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
* Must not have receipt of intranasal CS drips or CS-administering devices (eg, OptiNose device or stents) withing 1 month prior to screening
A Phase III, Randomized, multicenter, double-blind, placebo-controlled clinical trial of omalizumab in patients with chronic rhinosinusitis with nasal polyps.
Study Name Disease Major Inc / Criteria Major Exclusions Study Title
PT001102 Persistent Asthma * Age, 12 – 80 years of age
* Physician diagnosed asthma for at least 3 months
* Maintenance therapy using an ICS/LABA with the ISC 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•
* No oral corticosteroid use within 14 days prior to screening
* No current smokers and former smokers must have stopped > 6 months prior to screening
* No hospitalization for asthma within 3 months
* Cancer remission >5 years
A randomized, double-blind, parallel group, multi-center 24-Week Study Comparing the Efficacy and Safety of three doses of PT001 to Placebo and Open-label Spiriva Respimat in Subjects with Persistent Asthma.
Study Name Disease Major Inc / Criteria Major Exclusions Study Title
BioCryst
BCX7353-302
HAE * Male or Female ≥ 12 years of age
* HAE Type 1 or 2, defined as having a CINH functional level below 50% and a C4 below the LLN during screening
* Weight of ≥ 40kg
* Must have 2 HAE attacks within 56 days from screening visit
* Significant abnormal ECG (QTcF >450 msec
* No History of any significant cardiovascular abormalities
* ≤30 mL/min AST or ALT value ≥ 3 times the upper limit
* Suspected C1-INH resistance
* Positive HIV, HBV, or HCV
A phase III, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two dose levels of BCX7353 as an oral treatment for the prevention of attacks in subjects with hereditary angioedema.
Study Name Disease Major Inc / Criteria Major Exclusions Study Title
GSK 205715 Asthma * > 18 years of age or older
* Diagnosis of Asthma for at least 1 year prior to screening
* Required daily ICS/LABA for at least 12 weeks. Must be and remain on a stable dose.
*ICS 250 mcg/day of Fluticasone propionate or equivalent (Flovent)
* Pre FEV≥ 30% and ≤ 85% and Reversibility as ≥ 12%
* No COPD patients
* No tobacco uses
* Any exacerbation requiring changes in therapy within 6 weeks would exclude the patient
* No infection within 6 weeks of screening
A Phase III, randomized, double-blind, active controlled, parallel group safety study, comparing the efficacy, safety and tolerability of the fixed dose combinaton FF/UMEC/V1 with the fixed dose dual combination of FF/V1, administered once-daily via a dry powder inhaler in subjects with inadequatey controlled asthma.
Study Name Disease Major Inc / Criteria Major Exclusions Study Title
REGN688 Grass Pollen /Allergic Rhinitis * Male or Female ≥ 18 to 55
* History of grass pollen-induced seasonal allergic rhinitis
* Confirmed grass pollen by – positive SPT w/Timothy Grass extract (mean wheal diameter at least ≥5 mm greater than a negative control) & positive serum Timothy Grass-specific IgE ( ≥0.35KU/L)
* Positive NAC w/Timothy Grass extract at screening w/peak TNSS score  ≥7 out of 12
* Between the first non-zero dose and approximately 10 minutes after the highest dose of NAC, must experience either a >20% drop in PNIF or >/=3 sneezes must be counted
* Moderate- severe asthma
* FEV₁ >80%
*Significant recurrent sinusitis – 3 episodes per year for the last 2 years that required antibiotic treatment
* Chronic sinusitis (with or w/o nasal polyps)
* Any gross mechanical nasal obstruction, or nasal or sinus surgery
* Tobacco smoking within the last year
*Chronic obstructive pulmonary disease
*Other chronic disease (eg. heart, diabetes, hypertension)
*Previous allergy immunotherapy
* Previous exposure to dupilumab
*Treatment w/investigational drug within 2 months
* Known or suspected immunosuppression
*Positive for HIV, Hepatitis B or Hepatitis C
*Use of anti-IgE therapy within 6 months prior to screening
* Treatment w/ live (attenuated) vaccine within 3 months prior to screening & during the study
*Active chronic or acute infection requiring systemic treatment with antibiotics
* History of malignancy within 5 years before screening visit
* Primary immunodeficiency disorder
A Study to evaluate the Efficacy of Dupilumab as an adjunct for Subcutaneous Grass Immunotherapy to reduce provoked allergic rhinitis symptoms using the nasal allergen challenge model.
Study Name Disease Major Inc / Criteria Major Exclusions Study Title
D3250R00023 Severe Asthma – Observational Study *Severe asthma for 12 months prior to enrollment
*Receiving care from specialist physicians
*> 18 years of age or older
* Uncontrolled on asthma treatment consistent w/GINA Step 4 or 5, ² receiving high-dose ICS w/ additional controllers
*FDA approved monoclonal antibody agent for treatment
*Use of systemic corticosteroids or other systemic immunosuppressants for aaroximately 50% or more of the prior 12 months
* Received an investigational therapy for asthma, allergy, atopic disease, or eosinophilic disease as part of a clinical trial during the 6 months prior to enrollment. The CHRONICLE Study: A Longitudinal Prospective Observational Study of the Characteristics, treatment patterns and Health Outcomes of Individuals with Severe Asthma in the United States.
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