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Clinical trials identifierNCT02134353
Study codesDPM-CF-303
Study titleLong Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects
Drug (brand name)Mannitol (Bronchitol)
Drug administrationInhalation
Eligible CF patientsAdults with CF 
Controlled study?Yes, placebo controlled
Randomised study?Yes
Blinded study?Yes (double blinded. Neither the participant, nor the medical staff knows which group the participant is in)
Extension study?No
Study timeframeThe study was conducted between October 2014 and September 2017.

Study:This Phase 3 study was conducted in 126 sites in 21 countries. 7 CTN sites were involved (Bordeaux, Reims, Rennes, Leuven, Montpellier, Rome, Verona).
Aim:The aim was to determine the safety and efficacy of long-term treatment with inhaled dry powder mannitol in improving lung function in adults. This study was conducted to get marketing authorisation in the US.
Participants:423 adults with CF were enrolled.
Treatment:Adults were randomised to receive treatment with inhaled mannitol (400 mg twice daily) or placebo (twice daily) for 26 weeks. Mannitol has been on the market in Europe since 2012.
Efficacy:    Lung function, measured by forced expiratory volume in 1 second (FEV1). The change in lung function after 26 weeks of treatment was 2.24% better with mannitol than with placebo (p=0.025).
The mannitol and placebo groups had similar times to pulmonary exacerbation and hospitalisations due to pulmonary exacerbation.
Safety:Adverse events were similar in the mannitol and placebo groups. Overall safety was acceptable and similar to previous studies.
Data source:This preliminary summary of data provided here is from a press release from the manufacturer:
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