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

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 ef...

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Veröffentlicht in:	The European respiratory journal 2011-11, Vol.38 (5), p.1071-1080
Hauptverfasser:	BILTON, D, ROBINSON, P, COOPER, P, GALLAGHER, C. G, KOLBE, J, FOX, H, JAQUES, A, CHARLTON, B
Format:	Artikel
Sprache:	eng
Schlagworte:	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
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Zusammenfassung:	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 efficacy end-point was to determine the change in forced expiratory volume in 1 s (FEV₁) over the double-blind phase. Secondary end-points included changes in forced vital capacity and pulmonary exacerbations. A significant improvement in FEV₁ was seen over 26 weeks (p
ISSN:	0903-1936 1399-3003
DOI:	10.1183/09031936.00187510