Abstract

The purposes of this study is to compare two inhaled corticosteroids (beclomethasone dipropionate and fluticasone propionate), administered at doses of increasing biosystemic effect in patients with persistent asthma, for efficacy and adverse reactions. A total of 24 subjects will be enrolled. The study is 24 hours long and involves 17 visits; four of these visits require an overnight stay at the GCRC, the other visits last between 30 minutes and 2 and 1/2 hours, depending on the visit. The activities vary in each visit, but they are one or a combination of the following: blood and urine samples, lung function testing with beta agonist reversal (spirometry), methacholine challenge, exhaled nitric oxide, ACTH stimulation test, exercise test, sputum induction, allergen skin testing, urine pregnancy test for females and measurement of peak flow. The efficacy parameters that will be evaluated in the pilot study include FEV1, post bronchodilator maximum FEV1, change in PC20 based on methacholine-induced bronchospasm and inhibition of exercise-induced bronchospasm. Additional outcomes include: resolution of inflammation based on changes in sputum cytology, rate of improvement in FEV1 over time, changes in exhaled nitric oxide, symptom free days, and changes in asthma control. Cortisol suppression will be used as an adverse effect of the drugs.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000645-29
Application #
6413249
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1977-12-01
Project End
2004-11-30
Budget Start
Budget End
Support Year
29
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Columbia University (N.Y.)
Department
Type
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032

  Publications

Melhem, Nadine M; Keilp, John G; Porta, Giovanna et al. (2016) Blunted HPA Axis Activity in Suicide Attempters Compared to those at High Risk for Suicidal Behavior. Neuropsychopharmacology 41:1447-56
Dong, Chuanhui; Della-Morte, David; Rundek, Tatjana et al. (2016) Evidence to Maintain the Systolic Blood Pressure Treatment Threshold at 140 mm?Hg for Stroke Prevention: The Northern Manhattan Study. Hypertension 67:520-6
Buckley, Jessie P; Engel, Stephanie M; Braun, Joseph M et al. (2016) Prenatal Phthalate Exposures and Body Mass Index Among 4- to 7-Year-old Children: A Pooled Analysis. Epidemiology 27:449-58
Leung, Vivien; Chiu, Ya-Lin; Kotler, Donald P et al. (2016) Effect of Recombinant Human Growth Hormone and Rosiglitazone for HIV-Associated Abdominal Fat Accumulation on Adiponectin and other Markers of Inflammation. HIV Clin Trials 17:55-62
Rosenbaum, Michael; Leibel, Rudolph L (2016) Models of energy homeostasis in response to maintenance of reduced body weight. Obesity (Silver Spring) 24:1620-9
Garyu, Justin W; Meffre, Eric; Cotsapas, Chris et al. (2016) Progress and challenges for treating Type 1 diabetes. J Autoimmun 71:1-9
Widen, Elizabeth M; Whyatt, Robin M; Hoepner, Lori A et al. (2016) Gestational weight gain and obesity, adiposity and body size in African-American and Dominican children in the Bronx and Northern Manhattan. Matern Child Nutr 12:918-28
Maresca, Michelle M; Hoepner, Lori A; Hassoun, Abeer et al. (2016) Prenatal Exposure to Phthalates and Childhood Body Size in an Urban Cohort. Environ Health Perspect 124:514-20
Tooley, James E; Vudattu, Nalini; Choi, Jinmyung et al. (2016) Changes in T-cell subsets identify responders to FcR-nonbinding anti-CD3 mAb (teplizumab) in patients with type 1 diabetes. Eur J Immunol 46:230-41
Branis, Natalia M; Etesami, Marjan; Walker, Ryan W et al. (2015) Effect of a 1-week, eucaloric, moderately high-fat diet on peripheral insulin sensitivity in healthy premenopausal women. BMJ Open Diabetes Res Care 3:e000100

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