title: Pooled analysis of two large randomised phase III inhaled mannitol studies in cystic fibrosis.
abstract: BACKGROUND
  To evaluate safety and efficacy of inhaled mannitol treatment in subgroups of a large global CF population.
  
  
  METHODS
  Data were pooled from two multicentre, double-blind, randomised, controlled, parallel group phase III studies in which 600 patients inhaled either mannitol (400 mg) or control (mannitol 50 mg) twice a day for 26 weeks.
  
  
  RESULTS
  Both the mean absolute change in FEV(1) (mL) and relative change in FEV(1) by % predicted from baseline for mannitol (400 mg) versus control were statistically significant (73.42 mL, 3.56%, both p<0.001). Increases in FEV(1) were observed irrespective of rhDNase use. Significant improvements in FEV1 occurred in adults but not children (6-11) or adolescents (aged 12-17). Pulmonary exacerbation incidence was reduced by 29% (p=0.039) in the mannitol (400 mg) group.
  
  
  CONCLUSIONS
  Sustained six-month improvements in lung function and decreased pulmonary exacerbation incidence indicate that inhaled mannitol is an important additional drug in the treatment of CF.
authors.affiliation: Royal Brompton Hospital, London, United Kingdom. d.bilton@rbht.nhs.uk
authors.forename: Diana
authors.initials: D
authors.lastname: Bilton
authors.forename: Gabriel
authors.initials: G
authors.lastname: Bellon
authors.forename: Brett
authors.initials: B
authors.lastname: Charlton
authors.forename: Peter
authors.initials: P
authors.lastname: Cooper
authors.forename: Kris
authors.initials: K
authors.lastname: De Boeck
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Flume
authors.forename: Howard G
authors.initials: HG
authors.lastname: Fox
authors.forename: Charles G
authors.initials: CG
authors.lastname: Gallagher
authors.forename: David E
authors.initials: DE
authors.lastname: Geller
authors.forename: Eric G
authors.initials: EG
authors.lastname: Haarman
authors.forename: Helge U
authors.initials: HU
authors.lastname: Hebestreit
authors.forename: John
authors.initials: J
authors.lastname: Kolbe
authors.forename: Allen
authors.initials: A
authors.lastname: Lapey
authors.forename: Phil
authors.initials: P
authors.lastname: Robinson
authors.forename: Jian
authors.initials: J
authors.lastname: Wu
authors.forename: Jonathan B
authors.initials: JB
authors.lastname: Zuckerman
authors.forename: Moira L
authors.initials: ML
authors.lastname: Aitken
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D002648:Child; D003550:Cystic Fibrosis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008353:Mannitol / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D055815:Young Adult
chemical_list: D008353:Mannitol