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Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD

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  • Courtney Crim
  • Mark T Dransfield
  • Jean Bourbeau
  • Paul W Jones
  • Nicola A Hanania
  • Donald A Mahler
  • Jørgen Vestbo
  • Andrew Wachtel
  • Fernando J Martinez
  • Frank Barnhart
  • Sally Lettis
  • Peter M A Calverley
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RATIONALE: Radiographically confirmed pneumonia risk with inhaled corticosteroid use in chronic obstructive pulmonary disease (COPD) has not been assessed to date.

OBJECTIVES: To determine the incidence of pneumonia, risk factors, and clinical attributes with inhaled fluticasone furoate (FF) in patients with COPD with an exacerbation history.

METHODS: Two replicate, 1-year, double-blind clinical trials enrolled subjects with COPD with moderate to very severe airflow limitation and at least one exacerbation within the prior year. Subjects were randomized 1:1:1:1 to receive inhaled once-daily vilanterol (VI) 25 μg or VI 25 μg combined with 50, 100, or 200 μg FF. Subjects were required to have a chest radiograph at screening and within 48 hours of any suspected pneumonia or exacerbation.

MEASUREMENTS AND MAIN RESULTS: Among 3,255 randomized subjects, 205 pneumonia events occurred in 181 subjects. Chest imaging was available for 195 (95%) of these events. Chest radiographs were also obtained for 1,793 (70%) of the 2,545 moderate and severe exacerbations. For VI alone and the combination with 50, 100, or 200 μg FF, reported pneumonia incidence was 3, 6, 6, and 7%, respectively. However, for events with compatible parenchymal infiltrates, the respective incidences were 2, 4, 4, and 5%. Factors associated with at least a twofold increase in the risk of pneumonia with FF/VI treatment were being a current smoker, having prior pneumonia, body mass index <25 kg/m(2), and severe airflow limitation.

CONCLUSIONS: Radiographically confirmed pneumonia risk is increased with inhaled FF/VI, although at less than investigator-defined rates. Modifiable pneumonia risk factors should be considered when attempting to optimize COPD management. Clinical trial registered with www.clinicaltrials.gov (NCT01009463 [HZC102871]; NCT01017952 [HZC102970]).

Original languageEnglish
JournalAnnals of the American Thoracic Society
Volume12
Issue number1
Pages (from-to)27-34
Number of pages8
DOIs
Publication statusPublished - Jan 2015

    Research areas

  • Administration, Inhalation, Androstadienes, Benzyl Alcohols, Chlorobenzenes, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Forced Expiratory Volume, Humans, Incidence, Male, Middle Aged, Pneumonia, Pulmonary Disease, Chronic Obstructive, United States

ID: 46237523