Inhaled Dry-Powder Mannitol Safety and Efficacy for Patients With Bronchiectasis: Presented at ERS

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Title: Inhaled Dry-Powder Mannitol Safety and Efficacy for Patients With Bronchiectasis: Presented at ERS
URL: http://www.pslgroup.com/dg/22E3E6.htm
Doctor's Guide
October 6, 2008

By Chris Berrie

BERLIN -- October 6, 2008 -- Long-term inhaled dry-powder mannitol is safe and provides significantly enhanced mucus clearance and health-related quality of life (HRQoL) over placebo for patients with bronchiectasis, according to results of a multicentre, randomised, placebo-controlled, double-blind, parallel-arm, clinical trial.

Mannitol treatment also significantly reduced time to first use of rescue antibiotics and overall use of antibiotics, said principal investigator Diana Bilton, MD, Respiratory Medicine, Royal Brompton Hospital, London, United Kingdom, on behalf of the Bronchitol Study Team investigators.

"In bronchiectasis, which is a chronic disease where patients get recurrent infections, we have not got a lot of options for treatments," Dr. Bilton said on October 5th at the European Respiratory Society (ERS) 18th Annual Congress.

The concept was for a simple inhaler for this osmotic agent, to draw fluid into the airway lumen, thus providing more liquid secretions and making it easier to cough up.

Previously, researchers demonstrated that 2 weeks of inhaled mannitol treatment is beneficial for patients with bronchiectasis. So Dr. Bilton and colleagues conducted their study to determine the efficacy and safety of 12 weeks of treatment.

Mean baseline characteristics of the 343 patients in the intention-to-treat cohort included 61.5 years of age, forced expiratory volume at 1 second 74.8% of predicted, and duration of disease of 26.0 years. Causes of bronchiectasis were bacterial in 22.7%, viral in 16.0%, and unknown in 37.0%.

Patients were randomised to placebo (n = 112) or inhaled mannitol 320 mg (n = 231) twice daily for 3 months.

Mucus clearance was assessed as 24-hour sputum weight, and patient health-related quality of life was evaluated using the St. George's Respiratory Questionnaire (SGRQ). The researchers also assessed patient lung function, sputum microbiology, antibiotic use, exercise capacity, and safety.

In the active treatment group, 24-hour sputum weight did not change after 12 weeks (approximately 24 g), while the placebo group had a significant reduction (18 g; P < .002).

SGRQ total score for the mannitol treatment group showed significantly greater improvement after 12 weeks compared with placebo (reduction of 3.9 vs 2.0 units, respectively; P = .04). Similarly, the SGRQ impact score was significantly reduced with mannitol over placebo (reduction of 5.4 vs 3.0 units; P = .003). The remaining efficacy endpoints remained similar across the groups.

Due to this reduction in 24-hour sputum weight for placebo, Dr. Bilton said they looked at antibiotic use. "Although this was not originally designed to be looked at, what we found was that in the placebo group, the time to next antibiotic [use] was less than the active group," she said (log-rank P = .045).

There were no serious treatment-related adverse events, and no significant differences between treatment groups in adverse events, quantitative microbiology, and acquisition or loss of bacteria.

"We are hopeful that this is a signal that this will be a good treatment," with both mucus clearance and HRQoL significantly improved versus placebo, indicating that this long-term inhaled dry-powder mannitol treatment of patients with bronchiectasis can see the breaking of the vicious cycle of this disease, Dr. Bilton said.

Treatment for the study was supplied by Pharmaxis, Australia.

[Presentation title: Randomised, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Inhaled Dry Powder Mannitol in Bronchiectasis. Abstract P602]

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