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Inhaled mannitol improves lung function in cystic fibrosis.

Anna Jaques¹, Evangelia Daviskas², James A Turton³

¹Department of Clinical Research, Pharmaxis Ltd, Frenchs Forest, NSW, Australia.

|March 15, 2008

Summary

Inhaled mannitol significantly improved lung function in cystic fibrosis patients over two weeks. This therapy demonstrated adequate safety and good tolerability in the study population.

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Area of Science:

Pulmonary Medicine
Respiratory Pharmacology

Background:

Cystic Fibrosis (CF) is characterized by dehydrated airway mucus, leading to chronic infection and inflammation.
Mucus clearance is a critical component of CF daily therapy.
Inhaled mannitol, an osmotic agent, increases airway surface liquid to aid mucus clearance and improve respiratory health.

Purpose of the Study:

To evaluate the efficacy and safety of inhaled mannitol therapy in CF patients.
To assess the impact of inhaled mannitol on lung function and respiratory symptoms over a 2-week period.

Main Methods:

A randomized, double-blind, placebo-controlled, crossover study involving 39 subjects with mild-to-moderate CF lung disease.
Participants inhaled 420 mg of mannitol or placebo twice daily for 2 weeks, followed by a 2-week washout period and reciprocal treatment.
Assessments included lung function (FEV1, FVC), respiratory symptoms, quality of life, and safety.

Main Results:

Mannitol treatment significantly increased FEV1 by 7.0% compared to placebo (p < 0.001), with an absolute improvement of 121 mL.
Forced expiratory flow in the middle half of FVC also increased significantly with mannitol (15.5% vs. 0.7% for placebo; p < 0.02).
The safety profile of mannitol was adequate, with no serious adverse events reported.

Conclusions:

Inhaled mannitol significantly improves lung function in patients with cystic fibrosis over a 2-week treatment period.
Mannitol therapy is safe and well-tolerated in this patient population.