MANNITOL STUDY (PHASE 3)
Study ID number: DPM-CF-303
Official Title: Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects
Therapeutic Category: Mucolytic agent
Inhaled mannitol is also known as Bronchitol® on the market and is approved for use in Australia and the UK. An additional trial was conducted in hopes of expanding approval in other countries.
Mannitol is a mucolytic agent, which was investigated to see if it can help make the mucus less sticky in the lungs. It was designed to help with airway clearance and improve lung function. It could reduce the amount of bacteria remaining in the
lungs and therefore decrease the number of lung flare-ups and hospitalizations that result from that.
This was a Phase 3 study to learn about safety/tolerability and effects of inhaled mannitol when given to subjects with CF. Mannitol was investigated in how it may change your lung function (FEV1), quality of life, and frequency of pulmonary exacerbations (lung flareups), etc over a 26 week treatment period.
The study was completed. However, mannitol is not yet approved for use in Canada.
Source: ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/study/NCT02134353