Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
No gold standard therapy exists for clearing mucus from the airways of patients with
bronchiectasis. While rhDNase has a proven place in the treatment of cystic fibrosis (CF), it
failed to improve Forced expiratory volume in one second (FEV1) in a short-term non-CF
bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF
bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline
has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be
examined as a long term treatment option in bronchiectasis.
The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with
inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with
inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration;
improvement in quality of life and respiratory symptoms in patients with bronchiectasis and
pulmonary function in cystic fibrosis. The results of this current study in combination with
a recently completed 3 month study seek to confirm these early findings and to extend the
evidence to support its use as a mucoactive therapy in subjects with bronchiectasis.
We hypothesize that mannitol will improve the overall health and hygiene of the lung through
regular and effective clearing of the mucus load. As a consequence of the reduction in mucus
load and inflammatory process, the frequency of bronchiectasis related pulmonary
exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in
hospital and community health care costs are expected to change in line with improvements in
respiratory health.
Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52
week period. We will test these hypotheses using 400 mg mannitol twice daily (BD) against
control.