Mannitol (brand name Bronchitol) is a dry powder for inhalation, being developed by Pharmaxis, Inc.1 It works by drawing water into the airways in people with CF, thus moistening and thinning the sticky mucus that people with CF have, helping them cough easier. The therapy has been approved for the treatment of people with CF over six years old in Australia and over 18 throughout the European Union and in Israel.2

Mannitol clinical studies

Pharmaxis announced in July 2016 that it has completed recruiting participants with CF for a large and potentially pivotal Phase 3 clinical trial (NCT02134353) to provide evidence of the safety and efficacy of mannitol 400mg twice daily in adult participants over 18 years old. The results are expected in the second quarter of 2017 in accordance with the requirements of the FDA in order to obtain approval in the US in adults with CF.

The study is a 26 week, randomized and double-blind parallel group and besides safety and efficacy, its objectives include improvement in lung function and pulmonary exacerbations as measured by changes in forced expiration (FEV1) at week 6, 14 and 26.

The most common side effect people experience is cough (happens in more than 1 patient in 10). The most serious side effect is bronchospasm, which is the narrowing of the airways of the lung during the first treatments and coughing of blood.4

Cystic Fibrosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.



#ECFS2018 – Inhaled Mannitol Helps to Improve Lung Function in Adults with CF, Phase 3 Trial Data Show

Treatment with inhaled mannitol is safe and can help to improve lung function in adult patients with cystic fibrosis (CF), a post hoc analysis of data from a concluded Phase 3 trial show. These results were discussed at the recent 41st European Cystic Fibrosis Society (ECFS) Conference in Belgrade, Serbia, in an oral presentation titled “Phase […]

Pharmaxis Recruits 400 Cystic Fibrosis Patients for Phase 3 Study of Bronchitol Therapy

Pharmaxis announced that it has completed recruiting adult patients with cystic fibrosis (CF) for its large and potentially pivotal  Phase 3 clinical trial evaluating Bronchitol (mannitol) as an inhaled treatment.  The company expects to report results in the second quarter of 2017. Based on those results, the company will apply for U.S. Food and Drug Administration (FDA) approval of Bronchitol as a CF treatment. The […]

CF Pathogen Defies Treatment Attempt with Novel Drug Combination

A new study revealed that treating P. aeruginosa biofilms with the antibiotic tobramycin together with mannitol — two well-known therapies in treating lung infections in CF — did not reduce overall bacterial load. The study entitled “Mannitol Does Not Enhance Tobramycin Killing of Pseudomonas aeruginosa in a Cystic Fibrosis Model System of Biofilm Formation” was published in PLOS One by researchers […]

Inhaled Therapy Choices Expand Treatment Opportunities in Cystic Fibrosis

A recent review entitled “Inhaled therapy in cystic fibrosis: agents, devices and regimens” published in the journal Breathe explored the increasing number of inhaled therapeutic options for patients with CF, and how innovations in these therapies are dramatically improving quality of life for those with the disease. Historically, patients with cystic fibrosis had to engage […]

Inhaled Mannitol Found to be Helpful for Those With Cystic Fibrosis

Several studies have recently been released looking at the use of dry mannitol powder in an inhalation device for the management of cystic fibrosis. One study, entitled “Optimising inhaled mannitol for cystic fibrosis in an adult population,” published in Breathe, explored the safety and effectiveness of inhaled mannitol versus a placebo and found that those who took […]

Pharmaxis Osmotherapy Clinical Trial for CF Now Recruiting

Australian specialist pharmaceutical company Pharmaxis has just announced it has successfully enrolled the first participant in an international Phase 3 clinical trial designed to evaluate their lead pipeline product for cystic fibrosis, Bronchitol® (mannitol). Pharmaxis continues to develop novel treatments for chronic respiratory disorders, such as asthma, pulmonary fibrosis, lung cancer, and COPD. Cystic fibrosis (CF) is […]