Bronchitol: inhaled mucolytic for cystic fibrosis

Bronchitol (inhaled mannitol) is indicated as an adjunct to standard therapy in adults with cystic fibrosis.

Mannitol, the active ingredient in Bronchitol, is also available as an intravenous infusion for cerebral oedema
Mannitol, the active ingredient in Bronchitol, is also available as an intravenous infusion for cerebral oedema


Mannitol is a hyperosmotic agent given by dry powder inhalation. Its exact mechanism of action is unknown, but it may change the viscoelastic properties of mucus in the lungs, increase hydration of the periciliary fluid layer and contribute to increased mucus clearance through mucociliary activity.1


Two double-blind 26-week phase III studies were performed, in which patients with cystic fibrosis were randomised to receive inhaled mannitol 400mg or control (a sub-therapeutic 50mg dose of inhaled mannitol) twice daily. Participants could receive concomitant recombinant human deoxyribonuclease (rhDNase) and inhaled antibiotics, but hypertonic saline was not permitted.1

In study CF301, mean FEV1 improved by 6.5% (118.9ml) in patients receiving mannitol 400mg compared with 2.4% (26ml) in control patients (p<0.001). The treatment effect was significant for both rhDNase users and non-users.2

In study CF302, the relative change in mean FEV1 was 8.2% (106.5ml) in the treatment group and 4.5% (52.4ml) in the control group (p=0.029).3

The rate of protocol-defined pulmonary exacerbation (presence of specified symptoms and signs plus the use of iv antibiotics) was reduced by 26% with mannitol 400mg in both studies, but this difference did not reach significance.2,3


  1. Bronchitol Summary of Product Characteristics, April 2012.
  2. Bilton D et al. Eur Respir J 2011; 38: 1071-80.
  3. Aitken ML et al. Am J Respir Crit Care Med 2012; 185: 645–52.

View Bronchitol drug record

Further information: Pharmaxis

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Already registered?
Sign in

MIMS Product Slides

Product overviews prepared by the MIMS team, in a handy slide format.

Click here

Slides are initiated, funded & reviewed by the companies specified.

MIMS app

Access the full drug database and quick-reference tables on the go

Find out more