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Bronchitol publications

Bronchitol is licensed for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.

StudyDesignPopulationPrimary EndpointTreatmentPublication

CF-201

Short term efficacy and safety

Randomised

Multicentre

Double-blinded

Controlled

Cross-over

n=39

CF patients with FEV1 between 40 - 80% of predicted

Effect of two weeks twice daily treatment on FEV1

420mg b.i.d. for 14 days

 

Jaques A et al. Chest 2008; 133: 1388-96.

 

CF-202

Dose response

Randomised

Multicentre

Open label

Cross-over

n=48 

CF patients with FEV1 between 40 - 90% of predicted

Dose required to obtain clinical improvement in lung function measured as FEV1 and FVC

 

400mg b.i.d., then 40, 120, 240mg b.i.d. for 14 days

 

Teper A et al. Journal of Cystic Fibrosis 2011; 10: 1–8.

 

CF-301

Long term efficacy and safety

Randomised

Multicentre

Double-blinded

Controlled

Parallel arm

n=324 (ITT=295)

CF patients with FEV1 between 30 - 90% of predicted

Effect of Bronchitol compared to control on FEV1 over 26 weeks

(Patients could enter an optional 26-week, open label extension during which all subjects received Bronchitol)

 

400mg or control b.i.d.

 

Bilton D et al. Eur Respir J 2011; 38: 1071-1080.

 

CF-302

Long term efficacy and safety

Randomised

Multicentre

Double-blinded

Controlled

Parallel arm

n=342 (ITT=305)

CF patients with FEV1 between 40 - 90% of predicted

Effect of Bronchitol compared to control on FEV1 over 26 weeks

(Patients could enter an optional 26-week, open label extension during which all subjects received Bronchitol)

 

400mg or control b.i.d.

 

Aitken ML et al. Am J Respir Crit Care Med. 2012; 185(6): 645-652.

CF-301/CF-302

Long term efficacy and safety (adult data)

Flume PA, Aitken M, Bilton D, Agendt P,
Charlton B, Forster E, Fox HG, Hebestreit H, Kolbe J, Zuckerman JB, Button

Optimising inhaled mannitol
for cystic fibrosis in an adult population

Effect of Bronchitol compared to control on FEV1 over 26 weeks
(Patients could enter an optional 26-week, open label extension during which all subjects received Bronchitol)

 

400mg or control b.i.d

 

Breathe. 2015 March v11.

Adverse events should be reported to Pharmaxis Ltd by email: adverse.events@pharmaxis.com.au.