Inhaled alpha 1 -proteinase inhibitor therapy in patients with cystic fibrosis
| Autor: | Henry L. Dorkin, James F. Chmiel, Junliang Chen, David P. Nichols, Scott H. Donaldson, Rhonda Griffin, Patrick A. Flume, Amit Gaggar |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male 0301 basic medicine Pulmonary and Respiratory Medicine Pathology medicine.medical_specialty Serine Proteinase Inhibitors Time Factors Cystic Fibrosis Pharmacology Cystic fibrosis Article 03 medical and health sciences 0302 clinical medicine Double-Blind Method Administration Inhalation medicine Humans In patient Pediatrics Perinatology and Child Health Dose-Response Relationship Drug biology business.industry Sputum medicine.disease 3. Good health Treatment Outcome 030104 developmental biology 030228 respiratory system alpha 1-Antitrypsin Neutrophil elastase Pediatrics Perinatology and Child Health biology.protein Alpha1-proteinase inhibitor Female Leukocyte Elastase business Follow-Up Studies |
| Zdroj: | Journal of Cystic Fibrosis. 15:227-233 |
| ISSN: | 1569-1993 |
| DOI: | 10.1016/j.jcf.2015.07.009 |
| Popis: | Inhaled alpha1-proteinase inhibitor (PI) is known to reduce neutrophil elastase burden in some patients with CF. This phase 2a study was designed to test inhaled Alpha-1 HC, a new aerosolized alpha1-PI formulation, in CF patients.We performed a randomized, double-blind, placebo-controlled study and evaluated the safety of 100 or 200mg of inhaled Alpha-1 HC once daily for 3 weeks in subjects with CF. Thirty adult subjects were randomized in a 2:1 ratio to receive Alpha-1 HC or placebo.Drug delivery was confirmed by a dose-dependent increase in the sputum alpha1-PI. Seven (20.0%) of the 35 adverse events in the 100-mg dose group, 3 (13.0%) of 23 in the 200-mg dose group, and 4 (14.3%) of 28 in the placebo group were drug-related in these subjects. One serious adverse event occurred in 1 subject within each group.Alpha-1 HC inhalation was safe and well tolerated. |
| Databáze: | OpenAIRE |
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