Division of Allergy & Immunology

Clinical Trials

The Division of Allergy/Immunology is currently recruiting patients for the following trials:

  1. Phase IIB, randomized, double-blind, placebo-controlled, multi-center, dose-ranging study to assess the efficacy and safety of MSTT1041A in patients with uncontrolled severe asthma
  2. Multicenter, open-label, safety extension study with Benralizumab (MEDI- 563) for asthmatic adults on inhaled corticosteroid plus Long-acting ß2 agonist (MELTEMI)
  3. Prospective single arm longitudinal study to assess biomarkers in real world patients with severe asthma
  4. 52-week, multicenter, randomized, double-blind, parallel group, placebo controlled, Phase 3 study to evaluate the efficacy and safety of Tralokinumab in adults and adolescents with asthma inadequately controlled on inhaled corticosteroid plus long-acting ß2-agonist (STRATOS 2)
  5. Randomized, 24-week treatment, double-blind, placebo-controlled efficacy and safety study of dupilumab 300 mg every other week, in patients with bilateral nasal polyposis on a background therapy with intranasal corticosteroids.

Eligibility  

Currently we are recruiting adult patients with the following conditions:

  • Patients with nasal polyps
  • Severe asthmatics, who are not controlled despite taking daily asthma medications and had asthma exacerbations in the last 12 months.
  • Asthma, who use frequent albuterol despite being on inhaled steroids
  • Asthma, who do not take any controller medications
  • Asthma, who take medications, but do not need albuterol often
  • Asthma and aspirin allergy

We are also recruiting children 18 months to 3 years of age with at least 2 episodes of wheezing prior to the study enrollment.

Past Clinical Trials 

  1. Efficacy of early introduction of allergy immunotherapy in young children to reduce long-term asthma morbidity (AIR study) NCT01028560
  2. Diagnosis of aspirin hypersensitivity by measuring arachidonic acid metabolites after low dose aspirin challenge
  3. EXACT: A Prospective, Randomized, Double-Blind Study of the Efficacy of Xolair® in Atopic Asthmatics with Good Lung Capacity who Remain Difficult to Treat
  4. MOLLY: A Phase II, Randomized, Double-Blind, Placebo-Lebrikizumab (MILR1444A) in Adult Patients with Asthma who are not Taking Inhaled Corticosteroids
  5. HZA106837: A Long-Term, Randomized, souble-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once Daily in Subjects with Asthma  
  6. TENOR Genetech, INC
  7. SMART GSK
  8. STEAM AstraZeneca--A twelve-week, randomized, double-blind, double-dummy, placebo and active controlled study of SYMBICORT pMDI administered once daily in adults adolesents with asthma--2003-2005
  9. PEGASUS-002 Pfizer
  10. ATLANTIS AstraZeneca---A two-stage randomized, parallel group, multicenter, 7-month study to assess the efficacy and safety of SYMBICORT pMDI administered either as fixed or as an adjustable regimen versus a fixed regimen of Advair in subjects 12 years of age and older with asthma---2004-2005
  11. EXELS Genetech, INC---An Epidemiologic Study of Xolair (Omalizumab): Evaluating Clinical Effectiveness and Long-term in Patients with Moderate to Severe Asthma---2005-cont
  12. SFA100062 GSK---A Randomized.Parallel-Group, Double-Blind, ComparativeTrial Assessing Lung Function and Other Measures of Asthma Control in Adults and Adolescents, at least 12 Years of Age, with Persistent Asthma, Who Have Either a B16-Arg/Arg, a B16-Gly/Gly, or a B16-Arg/Gly Genotype and are Treated with Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50 mcg or Salmeterol DISKUS Product 100/50 mcg or Salmeterol DISKUS 50 mcg BID---2005-2006
  13. Xolair immunotherapy (PI) Novartis---A 26-week, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the effect of Xolair (omalizumab) on improving the tolerability of specific immunotherapy in patients with persistent allergic asthma--- 2006-2007
  14. EXTRA (PI) Genetech, INC---A Phase IIIB Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Xolair in Subjects with Moderate to Severe Persistent Asthma Who Are Inadequately Controlled With High-Dose Inhaled Corticosteroids and Long-Acting Beta-Agonists--2006-2007
  15. A-a study AstraZeneca---A 52-week, randomized, double-blind, parallel-group, multi-centre, Phase IIIB study comparing the long term safety of SYMBICORT pMDI 160/4.5 ug X 2 actuations twice daily to budesonide HFA pMDI 160 ug x 2 actuations twice daily in adult and adolescent (greater than or equal to 12 years) African American subjects with asthma--2007
  16. Back to scholl study Merck A Multicenter, Randomized,Double-blind, Placebo-Controlled Parallel Group 8-Week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients with Chronic Asthma—2006
  17. Asthma anti IL-13 Wyeth--A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of 3 Dose Levels of IMA-638 in Subjects with Persistent Asthma--2007
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