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Mannitol Dry Powder for Inhalation

In Patients with Cystic Fibrosis

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Abstract

Mannitol dry powder for inhalation has been developed for the treatment of patients with cystic fibrosis.

Two randomized, double-blind, multinational, 26-week, phase III trials (CF-301 and CF-302) examined the efficacy of inhaled dry powder mannitol in patients aged ≥6 years with cystic fibrosis who were receiving standard care (with a substantial proportion of patients receiving dornase alfa and antibacterial s at baseline). Good compliance was seen in both studies.

A sustained, significant (p<0.001) improvement in forced expiratory volume in 1 second (FEV1) [mean absolute change from baseline over 26 weeks; primary endpoint] was seen in patients with cystic fibrosis who received inhaled mannitol, compared with the control group, in the CF-301 trial, but not in the CF-302 trial (p = 0.059).

In both CF-301 and CF-302, the relative increase from baseline in percent predicted FEV1 and the improvement from baseline in forced vital capacity were significantly greater in patients receiving inhaled mannitol than in the control group.

In a pooled analysis of the CF-301 and CF-302 trials, the relative risk of a pulmonary exacerbation requiring intravenous antibacterials was significantly reduced by 29% for inhaled mannitol recipients versus the control group (relative risk 0.71; 95% CI 0.51, 0.98) [p = 0.039].

Inhaled dry powder mannitol was generally well tolerated in adults with cystic fibrosis in the CF-301 and CF-302 studies, with most treatment-emergent adverse events being of mild to moderate severity.

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Acknowledgements and Disclosures

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was also offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

The manuscript was reviewed by: D. Bilton, Respiratory Medicine, Royal Brompton Hospital, London, UK; T. Pressler, Copenhagen University Hospital, Cystic Fibrosis Center, Copenhagen, Denmark; J. Riethmüller, Department of Paediatrics, University Hospital Tübingen, Tübingen, Germany.

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  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand

    Celeste B. Burness & Gillian M. Keating

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  1. Celeste B. Burness
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  2. Gillian M. Keating
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Correspondence to Celeste B. Burness.

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Burness, C.B., Keating, G.M. Mannitol Dry Powder for Inhalation. Drugs 72, 1411–1421 (2012). https://doi.org/10.2165/11208950-000000000-00000

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