TABLE 3

Primary end-points: time to first exacerbation and frequency of exacerbations# in patients treated with ciprofloxacin dry powder for inhalation (DPI) versus placebo over 48 weeks

HR or IRR
(97.5% CI)
p-value
(Wald-type test)
Time to first exacerbation
 Ciprofloxacin DPI 14 days on/off versus pooled placebo0.53 (0.36–0.80)0.0005
 Ciprofloxacin DPI 28 days on/off versus pooled placebo0.73 (0.50–1.07)0.0650
Frequency of exacerbations
 Ciprofloxacin DPI 14 days on/off versus matching placebo0.61 (0.40–0.91)0.0061
 Ciprofloxacin DPI 28 days on/off versus matching placebo0.98 (0.64–1.48)0.8946

HR: hazard ratio; IRR: incidence rate ratio. #: for the primary end-points, an exacerbation (stringent definition) was required to meet three criteria: 1) worsening in at least three signs or symptoms (dyspnoea, wheezing, cough, 24-h sputum volume or sputum purulence) beyond normal day-to-day variation for at least 2 consecutive days, 2) fever (body temperature >38.0°C) or malaise/fatigue, and 3) systemic antibiotic treatment; : HRs were calculated for time to first exacerbation; IRRs were calculated for frequency of exacerbations.