{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T04:38:07Z","timestamp":1791175087140,"version":"4.1.0"},"reference-count":33,"publisher":"European Respiratory Society (ERS)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2011,3,20]]},"published-print":{"date-parts":[[2011,11]]},"abstract":"<jats:p>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<jats:italic>b.i.d.<\/jats:italic>) and control groups. The primary efficacy end-point was to determine the change in forced expiratory volume in 1 s (FEV<jats:sub>1<\/jats:sub>) over the double-blind phase. Secondary end-points included changes in forced vital capacity and pulmonary exacerbations.<\/jats:p><jats:p>A significant improvement in FEV<jats:sub>1<\/jats:sub>was seen over 26 weeks (p&lt;0.001) and was apparent by 6 weeks, irrespective of concomitant recombinant human deoxyribonuclease (rhDNase) use. At 26 weeks, there was a significant improvement in FEV<jats:sub>1<\/jats:sub>of 92.9 mL for subjects receiving mannitol compared with controls (change from baseline 118.9 mL (6.5%)<jats:italic>versus<\/jats:italic>26.0 mL (2.4%); p&lt;0.001). Improvements in FEV<jats:sub>1<\/jats:sub>were maintained up to 52 weeks in the OL part of the study. There was a 35.4% reduction in the incidence of having an exacerbation on mannitol (p=0.045).<\/jats:p><jats:p>The incidence of adverse events (AEs) was similar in both groups, although treatment-related AEs were higher in the mannitol compared with the control group. The most common mannitol-related AEs were cough, haemoptysis and pharyngolaryngeal pain.<\/jats:p><jats:p>Mannitol showed sustained, clinically meaningful benefit in airway function in CF, irrespective of concomitant rhDNase use. Mannitol appears to have an acceptable safety profile for patients with CF.<\/jats:p>","DOI":"10.1183\/09031936.00187510","type":"journal-article","created":{"date-parts":[[2011,4,9]],"date-time":"2011-04-09T01:19:03Z","timestamp":1302311943000},"page":"1071-1080","source":"Crossref","is-referenced-by-count":129,"title":["Inhaled dry powder mannitol in cystic fibrosis: an efficacy and safety study"],"prefix":"10.1183","volume":"38","author":[{"given":"D.","family":"Bilton","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Robinson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Cooper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.G.","family":"Gallagher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Kolbe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Fox","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Jaques","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B.","family":"Charlton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2011,4,8]]},"reference":[{"key":"2024102020380207000_38.5.1071.1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39391.713229.AD"},{"key":"2024102020380207000_38.5.1071.2","doi-asserted-by":"publisher","DOI":"10.1126\/science.2475911"},{"key":"2024102020380207000_38.5.1071.3","doi-asserted-by":"publisher","DOI":"10.4187\/aarc0427"},{"key":"2024102020380207000_38.5.1071.4","doi-asserted-by":"publisher","DOI":"10.1016\/S1526-0550(02)00005-7"},{"key":"2024102020380207000_38.5.1071.5","doi-asserted-by":"publisher","DOI":"10.1016\/S1097-2765(01)00286-6"},{"key":"2024102020380207000_38.5.1071.6","doi-asserted-by":"publisher","DOI":"10.1016\/S0092-8674(00)81724-9"},{"key":"2024102020380207000_38.5.1071.7","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199607183350307"},{"key":"2024102020380207000_38.5.1071.8","doi-asserted-by":"publisher","DOI":"10.1542\/peds.103.6.e72"},{"key":"2024102020380207000_38.5.1071.9","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcf.2009.09.003"},{"key":"2024102020380207000_38.5.1071.10","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200705-664OC"},{"key":"2024102020380207000_38.5.1071.11","unstructured":"Rowe RC Sheskey PJ Weller PJ , eds. 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