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Division of Pediatric Pulmonology, Allergy, Immunology, and Sleep Medicine

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Research in the Division of Pediatric Pulmonology, Allergy, Immunology, and Sleep Medicine

Research - 2014

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, ( has received many grants designed to study the impact of the environment on children’s health here in the Hudson Valley.


On-Going Studies, as of 05/28/2014


  1. A Long Term Prospective Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients with CF Treated with Pancreatic Enzyme Replacement Therapy.
  1. Longitudinal Assessment of Risk Factors for and Impact of Pseudomonas Aeruginosa Acquisition and Early-Anti-Pseudomonas Treatment in Children with Cystic Fibrosis.


  1. A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Repeat-dose Study of KB001A in Subjects with Cystic Fibrosis Infected with Pseudomonas aeruginosa.


  1. A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects with Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation.


  1. A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation.


  1. A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long -Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation.


  1. A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation.


  1. American Lung Association Asthma Patient Registry.  As an American Lung Association supported Asthma Clinical Research Center, we participate in a national database of patients with asthma.  The mission of this network is to perform large, real-world, practical clinical trials that will help patients with asthma, including both children and adults.


  1. Effect of Positive Airway Pressure on Reducing Airway Reactivity in Patients with Asthma.  This is an NHBLI supported multicenter trial of continuous positive airway pressure (CPAP) as a treatment for asthma. 


  1. The Long Acting Beta Agonist Stepdown Study. This is an ALA sponsored multicenter randomized, double blind trial of three modes of stepping down from combined inhaled corticosteroids and long acting beta agonists in patients with well controlled study.


  1. Smoking Asthmatics Pilot Study: Smoking Asthmatics Cohort Study. This is part of series of studies to be performed by the ALA ACRC network in adults with asthma who smoke.


  1. Differences in Pulmonary Function Between "Coughers" and "Wheezers" with Childhood  Asthma using Impulse Oscillometry.  This is an investigator-initiated respiratory physiology study examining differences pulmonary mechanics in children with asthma but different phenotypes.


  1. Effect of Thickened Liquids on Swallowing Function in Children Undergoing Modified Barium Swallow (Videofluoroscopic Swallowing Evaluation). This is a careful examination of the mechanics of swallowing, the results of which have already been presented at the American Thoracic Society meetings and is being submitted for publication.


  1. Long-term Respiratory Health Outcomes in Children Undergoing Videofluoroscopic Swallowing Evaluation.  Presented at the ATS this spring, this is a careful examination of the respiratory outcomes of children who underwent videofluoroscopic swallowing evaluations (Modified Barium Swallows) for possible dysphagia.


  1. Relationship Between Obstructive Sleep Apnea Syndrome and Urinary B-type Natriuretic Peptide in Children.  This ongoing investigator-initiated study is designed to test the hypothesis that a non-invasive biomarker, urinary BNP or NT-BNP will be a useful screening test in children with suspected obstructive sleep apnea syndrome.


  1. Obesity and Lung Function in Preschool Children with Physician-Diagnosed Asthma. This is an investigator initiated comparison of pulmonary function tests, including impulse oscillometry and lung clearance index, two relatively newer measures, in children with asthma and with or without obesity.
  1. Functional Health Literacy and Numeracy in Parents of Children with Asthma: Differences in Suburban and Rural Populations.


  1. Adequacy of Baseline Diagnosis and Treatment of Asthma as per the Expert Panel-3 Asthma Guidelines in Children Presenting to an ED for Acute Exacerbations of Asthma.
  1. The Effects of Temperature Variation of Liquids on Laryngeal Penetration & Aspiration in Children with Swallowing Dysfunction.


  1. Familial Haploidentical T-cell Depleted with T-cell Add-back Stem Cell Transplantation for Patients with High-Risk Sickle Cell Disease.  Our division is serving as the pulmonary function core for this NIH funded multicenter trial of stem cell transplant in patients with sickle cell disease.



Pending Studies, as of 05/28/2014


  1. A Multi-Center, Randomized, Controlled, Double-Blinded Study of the Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis Patients.
  1. A Phase 3 Efficacy and Safety Study of Ataluren (PTC 124) in Patients with Nonsense Mutation Cystic Fibrosis.


  1. A Randomized, Double-Blind, Placebo-Controlled, Cross-over Multi-Center Study to Assess the Efficacy and Safety of Inhaled  Tobramycin Nebulizer Solution for the Treatment of Early Infection of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to Less than 7 Years.


  1. Optimizing Treatment for Early Pseudomonas aeruginosa Infection in Cystic Fibrosis. This is a multicenter trial comparing different therapies proposed for early infections in patients with CF.


  1. A Multi-Center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of tobramycin Inhalation Powder Using Placebo Capsules.


  1. A Phase 3 Randomized, Double Blind, Placebo Controlled, Crossover Study with an Open Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a CFTR mRNA Splice Site Mutation.


  1. Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects.


  1. A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 80 or 160 mcg/Day of Beclomethasone  Dipropionate Delivered via Breath Actuated Inhaler (BAI) or Metered Dose Inhaler (MDI) in Pediatric Patients 5 Through 11 Years of Age with Persistent Asthma.


  1. The Relationship Between Implementation of the 2014 CF Foundation Infection Control Guidelines on the Prevalence and Incidence of Bacterial Respiratory Infections in Patients with Cystic Fibrosis.


  1. Intermittent Montelukast and Mometasone for Intermittent Childhood Asthma, a double-Blind Randomized Multicenter Trial.


  1. Prevalence and Determinants of Fixed Airflow Obstruction in Children with Asthma born Prematurely.
  1. Determinants of Treatment-Insensitive Airflow Obstruction in Children, a Multicenter Cohort Study.  This is an ALA ACRC multicenter cohort study, led by the faculty at New York Medical College, designed to fully characterize children with seemingly fixed obstructive lung disease (COPD). 


  1. Relationship Between Specific Antibody Deficiency and Atopy in Children with Recurrent Respiratory Infections.  This is an investigator-initiated study of our allergy faculty designed to examine the relationship between allergies and specific antibody deficiency, as manifested by poor response to pneumococcal vaccines.


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