Inhaled dry powder mannitol in cystic fibrosis: an efficacy and safety study

• Published in: The European respiratory journal Vol. 38; no. 5; pp. 1071 - 1080
• Main Authors: Bilton, D., Robinson, P., Cooper, P., Gallagher, C.G., Kolbe, J., Fox, H., Jaques, A., Charlton, B.
• Format: Journal Article
• Language: English
• Published: Leeds Maney 01.11.2011
• Subjects: Administration, Inhalation; Adolescent; Biological and medical sciences; Child; Cystic Fibrosis - drug therapy; Cystic Fibrosis - physiopathology; Deoxyribonucleases - therapeutic use; Double-Blind Method; Dry Powder Inhalers; Errors of metabolism; Female; Forced Expiratory Volume; Humans; Male; Mannitol - administration & dosage; Mannitol - adverse effects; Medical sciences; Metabolic diseases; Miscellaneous hereditary metabolic disorders; Pneumology; Recombinant Proteins - therapeutic use; Vital Capacity; Delivery system; clinical study; Respiratory disease; forced expiratory volume in 1 s; Metabolic diseases; Cystic fibrosis; Dry; Clearance; dry powder inhalers; Powder; Genetic disease; Inhalation; Efficiency; Volume; Airway mucociliary clearance; mannitol dry powder; Mannitol; Inhaler; Digestive diseases; Safety; Pancreatic disease; Pneumology

This international phase III study of inhaled dry powder mannitol was a randomised, double-blind, 26-week study, followed by a further 26-week, open-label (OL) extension. 324 cystic fibrosis (CF) patients were randomised, in a 3:2 ratio, to mannitol (400 mg b.i.d. ) and control groups. The primary e...