Safety and efficacy of nebulized zanamivir in hospitalized patients with serious influenza

Michael G. Ison, John W. Gnann, Stephanie Nagy-Agren, John Treanor, Carlos Paya, Roy Steigbigel, Michael Elliott, Heidi L. Weiss, Frederick G. Hayden*

*Corresponding author for this work

Research output: Contribution to journalArticle

109 Scopus citations

Abstract

Influenza is an important cause of hospitalization due to lower respiratory tract involvement for which there is no specific antiviral treatment with proven efficacy. We conducted a double-blind, randomized, placebo-controlled trial to assess the tolerability and efficacy of nebulized zanamivir (16 mg four times a day) in combination with rimantadine compared to rimantadine with nebulized saline for treating influenza in adults hospitalized with influenza. Twenty patients tolerated the inhaled zanamivir (ZNV) plus rimantadine without decline in peak expiratory flow rates compared to the 21 who received inhaled saline. The study was terminated early because the approval of ZNV made further enrolment untenable. No significant differences were observed in the proportion of patients shedding Virus by treatment day 3 (57% ZNV plus rimantadine, 67% placebo plus rimantadine), or in the durations of hospitalization and supplemental oxygen use. More ZNV plus rimantadine recipients exhibited no or mild cough on day 3 of treatment (94 vs 55%, P=O.01). Two rimantadine-resistant viruses emerged during rimantadine monotherapy; no ZNV resistance was observed. Nebulized ZNV appears to be well tolerated in this hospitalized population but further studies are needed to assess its efficacy.

Original languageEnglish (US)
Pages (from-to)183-190
Number of pages8
JournalAntiviral Therapy
Volume8
Issue number3
StatePublished - Jun 1 2003

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

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    Ison, M. G., Gnann, J. W., Nagy-Agren, S., Treanor, J., Paya, C., Steigbigel, R., Elliott, M., Weiss, H. L., & Hayden, F. G. (2003). Safety and efficacy of nebulized zanamivir in hospitalized patients with serious influenza. Antiviral Therapy, 8(3), 183-190.