{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T02:40:19Z","timestamp":1789526419946,"version":"build-2803163510"},"reference-count":28,"publisher":"European Respiratory Society (ERS)","issue":"4","license":[{"start":{"date-parts":[[2020,6,18]],"date-time":"2020-06-18T00:00:00Z","timestamp":1592438400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.ersjournals.com\/user-licence"}],"funder":[{"name":"Aradigm"},{"DOI":"10.13039\/501100000351","name":"British Lung Foundation","doi-asserted-by":"publisher","award":["BLF Chair"],"award-info":[{"award-number":["BLF Chair"]}],"id":[{"id":"10.13039\/501100000351","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2020,5,21]]},"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:p>It is not known if inhaled antibiotics improve respiratory symptoms in patients with bronchiectasis. In the recent phase-3 ORBIT trials, 48 weeks' treatment with ARD-3150 (inhaled liposomal ciprofloxacin) did not significantly improve symptoms using the prespecified method of analysis comparing baseline symptoms to those after 48\u2005weeks, when patients had been off treatment for 28\u2005days. This method of analysis does not take account of possible improvements in symptoms while on active treatment.<\/jats:p><jats:p>A<jats:italic>post hoc<\/jats:italic>analysis of two identical randomised trials of ARD-3150 (ORBIT-3 and -4) administered 28 days on and 28\u2005days off in patients with bronchiectasis and chronic<jats:italic>Pseudomonas aeruginosa<\/jats:italic>infection. The quality-of-life bronchiectasis respiratory symptom scale (QOL-B-RSS), which has a one-week recall period, was administered every 28 days. We examined whether respiratory symptoms improved during on-treatment periods and the relationship of changes in QOL-B-RSS to changes in bacterial load using a mixed-model repeated measures approach.<\/jats:p><jats:p>ARD-3150 treatment resulted in a significant improvement in respiratory symptoms during the on-treatment periods with concordant results between ORBIT-3 (estimate 1.4 points,<jats:sc>se<\/jats:sc>0.49; p=0.004) and ORBIT-4 (estimate 1.1 point,<jats:sc>se<\/jats:sc>0.41; p=0.006). The proportion of patients achieving a symptom improvement above the minimum clinically important difference was higher with ARD-3150 compared with placebo during on-treatment cycles (p=0.024). Changes in respiratory symptoms were correlated with changes in bacterial load in the treatment group (r=\u22120.89, p&lt;0.0001). Individual estimates for decrements in the QOL-B RSS during exacerbation were \u22129.4 points (<jats:sc>se<\/jats:sc>0.91) in ORBIT-3 and \u221210.8 points (0.74) in ORBIT-4 (both p&lt;0.0001).<\/jats:p><jats:p>Inhaled ARD-3150 resulted in significant improvements in respiratory symptoms during the on-treatment periods which were lost during off-treatment periods. These results supports the concept that reducing bacterial load can improve respiratory symptoms in patients with bronchiectasis.<\/jats:p>","DOI":"10.1183\/13993003.00110-2020","type":"journal-article","created":{"date-parts":[[2020,6,18]],"date-time":"2020-06-18T20:02:08Z","timestamp":1592510528000},"page":"2000110","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":50,"title":["Changes in respiratory symptoms during 48-week treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis: results from the ORBIT-3 and -4 studies"],"prefix":"10.1183","volume":"56","author":[{"given":"James D.","family":"Chalmers","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Cipolla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce","family":"Thompson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela M.","family":"Davis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"O'Donnell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory","family":"Tino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Igor","family":"Gonda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Haworth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juergen","family":"Froehlich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2020,6,18]]},"reference":[{"key":"2024102101441919000_56.4.2000110.1","doi-asserted-by":"crossref","unstructured":"Spinou A , Siegert RJ , Guan W-J , et al. The development and validation of the Bronchiectasis Health Questionnaire. 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RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. 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