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Research

Research is essential to the Division of Division of Pediatric Pulmonology, Allergy, Immunology, and Sleep Medicine. We have a large faculty and three research coordinators in our division. Our research portfolio and grant support have steadily grown every year, and reflect a wide variety of academic interests. Our focus has primarily been on clinical or translational research, particularly concerning childhood asthma, cystic fibrosis, and the respiratory mechanics of children with respiratory disease. We are particularly proud of our respiratory laboratories, where both bench research and clinical pediatric pulmonary function tests are performed. We perform dozens of extramurally funded projects at any one time, with funding primarily from NIH, the Cystic Fibrosis Foundation, the American Lung Association, and the pharmaceutical industry. Our division has been an American Lung Association supported Asthma Clinical Research Center since the inception of that program in 1999. Our center is one of only 18 such centers in the nation, and one of only 5 such centers whose principal investigator is a pediatric asthma specialist. We also are a member of the Cystic Fibrosis Foundation Therapeutics Development Network, funded by the CF Foundation to perform multicenter clinical trials. In the last five years, our division’s Children’s Environmental Health Center of the Hudson Valley, (www.childrensenvironment.org) has received many grants designed to study the impact of the environment on children’s health here in the Hudson Valley.

As of June 23, 2017

Currently Open:

  1. Childhood Pulmonary Complications in a Birth Cohort after a Randomized Trial of Antenatal Corticosteroids: the ALPS Follow-Up Study (The ALPS Study)
  2. A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients with Cystic Fibrosis Treated with Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol across Sponsors- CFFC-OB-11 (The CFFC study)
  3. A Phase 2, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of CTP-656 with an Open Label Active Comparator in Patients with Cystic Fibrosis with CFTR Gating Mutations (The CONCERT Study)
  4. Longitudinal Assessment of Risk Factors for Impact of Pseudomonas aeruginosa Acquisition & Early Anti-Pseudomonal Treatment in Children with Cystic Fibrosis (The EPIC Observational Study)
  5. Cystic Fibrosis Patient Registry (The PortCF Registry)
  6. Recorded Home Oximetry to Optimize Oxygen Weaning In Premature Infants (The RHO Study)
  7. Resistant Airflow Obstruction in Children with Asthma (The ROCAS Study)
  8. A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Monotherapy and Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis (The VX-440 Study)
  9. Fixed Obstruction in Children with Asthma born Prematurely (The ENO Study)
  10. Inhaled Bronchodilator Effect on Respiratory Impedance by FOT in CF and Asthma (The IOS Study)
  11. The Effects of Temperature Variation of Liquids on Laryngeal Penetration & Aspiration in Children with Swallowing Dysfunction (The Dysphagia Study)
  12. Parental Self-Reported Environmental Exposures in Over 9,000 Children with Respiratory Illness (The Exposure Study)
  13. Massively Parallel Sequencing to Identify Microbiological Organisms in Bronchoalveolar Lavage
  14. Fluid in Children, Adolescents and Young Adults Post Hematopoietic Stem Cell Transplant (The BAL Study)
  15. Assessment of the Usefulness of a reformatted Asthma Tool developed by Sesame Street in Communities (The Sesame Study)
  16. Multicenter Study Assessing Knowledge, Attitudes, and Practices of People with CF Regarding Safety Monitoring in CF Clinical Trials (The SPARK Study)
  17. Standardized Treatment of Pulmonary Exacerbations II (The STOP2 Study)
  18. Single Site Prospective Research study testing a Connected Ecosystem of asthma products for children and parents, Protocol: RDD-16127-SPRTE-BM (The SPRTE Study)
  19. Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation (The VX-114 Study)
  20. Allergy Evaluations of Children with Persistent Asthma (The A-A QI Study)
  21. Ventilation Non-Homogeneity in Children with Scoliosis (The Scoliosis Study)
  22. Assessing the Relationship between Eosinophilic Esophagitis and Atopic Disorders in Children (The EOE Study)
  23. Assessing the Relationship between the Use of Personal Care Products (PCP) and Asthma (The Care Product Study)
  24. Airway microbiome in children with asthma and second hand tobacco smoke exposure (The ETS Microbiome Study)
  25. Assessing New Testing Models for Lyme Disease (The Lyme Study)

New Studies Soon to Open

  1. Aztreonam Lysine for Pseudomonas Infection Eradication 2 Study (The ALPINE 2 Study)
  2. A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency (The SIMPLICITY Study)
  3. Newborn Screening for Severe Combined Immunodeficiency: Next Generation Sequencing and Long-Term Follow-up (The NBS SCID Study)
  4. A Phase 2b, Open-label, Multicenter, Randomized, Active Controlled Trial to Evaluate Fosfomycin/ Tobramycin for Inhalation Solution in Subjects with Cystic Fibrosis and Pseudomonas aeruginosa (The CX-FTI-204 Study)
  5. Engineering Evaluation of the Helix Ventilator (The Philips HELIX Study)
  6. A Phase Three Study of JBT-101 in Cystic Fibrosis (The CORBUS Phase 3 Study, full title not yet finalized)
  7. Nasal Nitric Oxide in Children with Asthma and Secondhand Tobacco Smoke Exposure (The Nasal NO Study)
  8. Airway closing index and exercise-induced bronchospasm in children with asthma (The Bronchospasm Study)
  9. Defibrotide in Sickle Cell Disease (The Defibrotide Study)
  10. A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-440 in Combination With Tezacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F508del/MF) (The VX-440-102 Study)

Studies Closed to Enrollment and Undergoing Data Analysis

  1. Anxiety and COPD Evaluation (The ACE Study)
  2. A Phase Two, Double-Blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis, JBT101-CF-001 (The CORBUS Study)
  3. Long-Acting Beta Agonist Step Down Study (The LASST Study)
  4. Long-Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Trail in Adult CF Subjects, Protocol DPM-CF-303 (The Mannitol Study)
  5. The Relationship between Implementation of the 2013 CF Foundation Infection Control Guidelines on the Prevalence and Incidence of Bacterial Respiratory Infections in Patients with Cystic Fibrosis (The CF-QI Study)
  6. Evaluation and Management of Cough in Children by Primary Care Pediatricians (The COUGH Study)
  7. Effects of Environmental Tobacco Smoke Exposure on Obesity (The ETS-Obesity Study)
  8. Prevalence of Atopy in Children with Specific Antibody Deficiency (The Pneumococcal Study)
  9. Assessing the Association between EPAs, Competencies, and Milestones in the Pediatric Subspecialties (The EPA Study)
  10. Epidemiology of Enterovirus D68: Lower Hudson Valley during the 2014 US National Outbreak and Comparison of Severity of Lower Respiratory Disease in Children Testing Positive for D68 versus Other Viral Pathogens (The EVD68 Study)
  11. Improving Specialty Care Follow-up of Children Hospitalized for Asthma
  12. Optimizing Treatment for Early Pseudomonas aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo Controlled, Double-Blind, Randomized Trial (The OPTIMIZE-IP-12 Study)
  13. A Two-Part Multicenter Prospective Longitudinal Study of CFTR-Dependent Disease Profiling in Cystic Fibrosis (The PROSPECT Study)
  14. A Phase 2A Randomized, Double-Blind, Placebo-Controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 and Older with Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated with Orkambi (The VX-371 Study)
  15. Learning from Parental Experiences with Cystic Fibrosis to Improve Services in New York State; Convenience Sample, Multi-Center Study of the Experience of Parents after they are notified about an Abnormal Newborn Screening Test for Cystic Fibrosis (The CF Screen Study)
  16. A Phase 3, Randomized, Double-Blind, Placebo Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function (The VX14-661-108 Study)
  17. A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-Term Treatment with VX-661 in Combination with Ivacaftor in Subjects Aged 12 Years and Older with Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation (The VX14-661-110 Study)
  18. Resistant Airway Obstruction in Children (The REACH Study)
  19. Improving Specialty Care Follow-up of Children Hospitalized for Asthma (The Asthma QI Study)