INTENDED FOR UK & IRELAND HEALTHCARE PROFESSIONALS

INTENDED FOR UK & IRELAND HEALTHCARE PROFESSIONALS

PRESCRIBING INFORMATION

Overview of Bronchitol® (mannitol) registration studies in adults

  • An integrated data analysis of CF301 and CF3021,2

Study aim: to evaluate the safety and efficacy of inhaled mannitol in a large population of patients with CF in order to optimise subgroup analyses in adult patients with CF

Study design: integrated data analysis of two Phase III, randomised 3:2, double-blind with open-label extension studies with nearly identical protocols (CF301 and CF302)

Age range in study: subgroup analysis of adult population ≥18 years

Primary endpoint: change in FEVfrom baseline over 26 weeks of treatment

Key secondary endpoints: other lung function parameters (FVC, FEF25–75%), pulmonary exacerbations, safety

CHANGE IN FEV1 IN ITT POPULATION IN ADULTS ≥ 18 YEARS (CF301 & CF302)

Adapted from Flume PA, et al. Breathe (Sheff) 2015;11:39-48.

CHANGE IN FEV1 FROM BASELINE TO WEEK 52 IN ADULTS ≥ 18 YEARS (CF301 & CF302)

Adapted from Flume PA, et al. Breathe (Sheff) 2015;11:39-48.

MEAN WEIGHT CHANGE IN SPUTUM (GRAMS) 30 MINS AFTER ADMINISTRATION IN ADULTS ≥ 18 YEARS (CF301 & CF302)

Adapted from Aitken M, et al. ECFS Dublin 2012 (Abstract #47).

STUDY OVERVIEW

BID, twice daily; CI, confidence interval; FEF25–75, forced expiratory flow at 25 to 75 percent of FVC; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; rhDNase, dornase alfa; HTS, hypertonic saline


1. Aitken M, et al. ECFS Dublin 2012 (Abstract  #47).
2. Flume PA, et al. Breathe (Sheff) 2015;11:39-48.