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Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study

Robert Wilson, Tobias Welte, Eva Polverino, Anthony De Soyza, Hugh Greville, Anne O'Donnell, Jeff Alder, Peter Reimnitz, Barbara Hampel
European Respiratory Journal 2013 41: 1107-1115; DOI: 10.1183/09031936.00071312
Robert Wilson
*Host Defence Unit, Royal Brompton Hospital, London
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  • For correspondence: r.wilson@rbht.nhs.uk
Tobias Welte
#Hannover Medical School, Hannover
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Eva Polverino
¶Hospital Clinic de Barcelona IDIBAPS, CIBERES, Barcelona, Spain
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Anthony De Soyza
+Newcastle University and Freeman Hospital, Newcastle upon Tyne, UK
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Hugh Greville
§Royal Adelaide Hospital, Adelaide, Australia
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Anne O'Donnell
fGeorgetown University Hospital, Washington, DC,
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Jeff Alder
**Bayer HealthCare Pharmaceuticals Inc., Montville, NJ, USA
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Peter Reimnitz
##Bayer Pharma AG, Wuppertal
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Barbara Hampel
¶¶Bayer Pharma AG, Berlin, Germany
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  • Article
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  • Figure 1–
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    Figure 1–

    Study design and subject disposition. Protocol violations in screening failures included no positive culture (n=23), inadequate sputum (n=50), forced expiratory volume in 1 s outside range (n=6), exacerbations during screening (n=2), on antibacterials (n=6), no further information (n=25) and other (n=10). DPI: dry powder for inhalation.

  • Figure 2–
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    Figure 2–

    Mean bacterial load for the a) modified intent-to-treat population and b) per-protocol populations. Only results from valid cultures were considered. Cultures were excluded if subjects were administered concomitant antibacterials, if there were >25 squamous epithelial cells in the absence of Pseudomonas aeruginosa or if there were ≤25 leukocytes for P. aeruginosa-negative cultures pre-therapy. DPI: dry powder for inhalation. Shaded area indicates treatment period (days). #: number of patients with valid sputum cultures. ***: p<0.001.

  • Figure 3–
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    Figure 3–

    Mean colony count of selected pathogens at baseline and at end of treatment. Only results from valid cultures were considered. Cultures were excluded if subjects were administered concomitant antibacterials, if there were >25 squamous epithelial cells in absence of Pseudomonas aeruginosa or if there were ≤25 leukocytes for P. aeruginosa-negative cultures pre-therapy. DPI: dry powder for inhalation; EOT: end of treatment.

  • Figure 4–
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    Figure 4–

    Occurrence of exacerbations requiring antibacterial intervention throughout the study (modified intent-to-treat population). 22 subjects in the ciprofloxacin DPI group and 25 subjects in the placebo group experienced an exacerbation. Of these, 14 subjects in the ciprofloxacin DPI group and 18 subjects in the placebo group required antibacterial treatment. DPI: dry powder for inhalation. Shaded area indicates treatment period (days).

Tables

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  • Table 1– Demographic and baseline data (modified intent-to-treat/safety population)
    CharacteristicCiprofloxacin DPIPlacebo
    Subjects n6064
    Age years64.7±11.861.4±11.9
    Sex
     Male21 (35.0)21 (32.8)
     Female39 (65.0)43 (67.2)
    Ethnicity
     Caucasian60 (100.0)63 (98.4)
     Asian01 (1.6)
    Weight kg70.2±16.469.1±17.2
    BMI kg·m−225.6±5.525.1±5.6
    FEV1 % pred57.2±13.754.6±14.8
    Subjects with exacerbations in previous 12 months
     1–2 exacerbations30 (50.0)35 (54.7)
     3–4 exacerbations25 (41.7)26 (40.6)
     ≥5 exacerbations5 (8.3)3 (4.7)
    Baseline total bacterial load log10 CFU·g−17.19±1.946.92±1.90
    Baseline bacterial isolates in ≥5% subjects#
     Pseudomonas aeruginosa32 (53.3)35 (54.7)
     Haemophilus influenzae14 (23.3)16 (25.0)
     Staphylococcus aureus8 (13.3)17 (26.6)
     Streptococcus pneumoniae7 (11.7)2 (3.1)
     Moraxella catarrhalis5 (8.3)3 (4.7)
     Klebsiella pneumoniae5 (8.3)0
     Proteus mirabilis3 (5.0)4 (6.3)
     Klebsiella oxytoca3 (5.0)2 (3.1)
    • Data are presented as mean±sd or n (%), unless otherwise stated. DPI: dry powder for inhalation; BMI: body mass index; FEV1: forced expiratory volume in 1 s; % pred: % predicted. #: no significant differences between ciprofloxacin DPI and placebo for isolates were reported apart from for K. pneumoniae (p=0.024).

  • Table 2– Number of subjects with eradication (negative bacterial culture, modified intent-to-treat population)
    Time periodCiprofloxacin DPIPlacebop-value#
    During treatment visit (day 8)20/42 (47.6)6/51 (11.8)<0.001
    End of treatment (day 29)14/40 (35.0)4/49 (8.2)0.001
    2-week follow-up (day 42)6/36 (16.7)4/37 (10.8)0.359
    4-week follow-up (day 56)4/31 (12.9)1/28 (3.6)0.617
    8-week follow-up (day 84)4/27 (14.8)2/25 (8.0)0.763
    • Data are presented as n/N (%), unless otherwise stated. DPI: dry powder for inhalation. #: based on Cochran–Mantel–Haenszel test stratified by centre/cluster of centre.

  • Table 3– Sputum colour in the modified intent-to-treat/safety population with available sputum samples
    Ciprofloxacin DPIPlacebop-value
    Baseline total subjects6063#0.220¶
     No sputum/clear5 (8.3)7 (11.1)
     Yellow29 (48.3)23 (36.5)
     Green25 (41.7)28 (44.4)
     Rust1 (1.7)5 (7.9)
    End of treatment49520.026¶, 0.029+
     No sputum/clear12 (24.5)9 (17.3)
     Yellow31 (63.3)26 (50.0)
     Green5 (10.2)17 (32.7)
     Rust1 (2.0)0
    4-week follow-up40370.494¶, 0.609+
     No sputum/clear10 (25.0)5 (13.5)
     Yellow16 (40.0)22 (59.5)
     Green11 (27.5)9 (24.3)
     Rust3 (7.5)1 (2.7)
    • Data are presented as n or n (%), unless otherwise stated. DPI: dry powder for inhalation. #: no sputum information was available for one patient; ¶: based on Cochran–Mantel–Haenszel test with ridit scores test stratified by centre/cluster of centre; +: based on Cochran–Mantel–Haenszel test with ridit scores test stratified by centre/cluster of centre and baseline sputum colour.

  • Table 4– Summary of adverse events (AEs) (modified intent-to-treat/safety population)
    AECiprofloxacin DPIPlacebop-value
    Subjects n6064
    Subjects with any AEs50 (83.3)54 (84.4)1.000
    Patients with any treatment-emergent AEs41 (68.3)42 (65.6)0.849
    Patients with treatment-related AEs21 (35.0)17 (26.6)0.335
    Treatment-emergent AEs reported in >5% subjects
     Product taste abnormal8 (13.3)7 (10.9)0.786
     Dysgeusia4 (6.7)1 (1.6)0.197
     Cough05 (7.8)0.058
     Exacerbation of bronchiectasis7 (11.7)14 (21.9)0.155
     Headache4 (6.7)5 (7.8)1.000
    Subjects with treatment-emergent serious AEs#2 (3.3)3 (4.7)1.000
     Complex pain syndrome1 (1.7)00.484
     Hallucination1 (1.7)00.484
     Exacerbation of bronchiectasis03 (4.7)0.245
     Sepsis01 (1.6)1.000
    Deaths00
    • Data are presented as n (%), unless otherwise stated. DPI: dry powder for inhalation. #: none considered to be drug related.

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      Materials and methods
      Results � modified intent-to-treat analysis set
      Results � per-protocol analysis set
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Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study
Robert Wilson, Tobias Welte, Eva Polverino, Anthony De Soyza, Hugh Greville, Anne O'Donnell, Jeff Alder, Peter Reimnitz, Barbara Hampel
European Respiratory Journal May 2013, 41 (5) 1107-1115; DOI: 10.1183/09031936.00071312

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Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study
Robert Wilson, Tobias Welte, Eva Polverino, Anthony De Soyza, Hugh Greville, Anne O'Donnell, Jeff Alder, Peter Reimnitz, Barbara Hampel
European Respiratory Journal May 2013, 41 (5) 1107-1115; DOI: 10.1183/09031936.00071312
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