Inhaled alpha1-proteinase inhibitor therapy in patients with cystic fibrosis.

Academic Article

Abstract

  • BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Alpha-1 HC inhalation was safe and well tolerated.
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    Published In

    Keywords

  • Alpha-1 HC, Alpha-1 antitrypsin, Cystic fibrosis, Prolastin, Administration, Inhalation, Adult, Cystic Fibrosis, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Leukocyte Elastase, Male, Serine Proteinase Inhibitors, Sputum, Time Factors, Treatment Outcome, alpha 1-Antitrypsin
  • Digital Object Identifier (doi)

    Pubmed Id

  • 9740021
  • Author List

  • Gaggar A; Chen J; Chmiel JF; Dorkin HL; Flume PA; Griffin R; Nichols D; Donaldson SH
  • Start Page

  • 227
  • End Page

  • 233
  • Volume

  • 15
  • Issue

  • 2