{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T03:09:38Z","timestamp":1761016178484,"version":"3.40.4"},"reference-count":1,"publisher":"S. Karger AG","issue":"6","license":[{"start":{"date-parts":[[2000,1,1]],"date-time":"2000-01-01T00:00:00Z","timestamp":946684800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"},{"start":{"date-parts":[[2000,1,1]],"date-time":"2000-01-01T00:00:00Z","timestamp":946684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Respiration"],"published-print":{"date-parts":[[2000]]},"abstract":"<i>Background:<\/i> The phase-out of chlorofluorocarbons (CFCs) for metered dose inhalers (MDIs) has prompted the development of alternative propellants and the design of propellant-free devices for inhalation therapy. <i>Objective:<\/i> This study was carried out to determine the dose of fenoterol inhaled from Respimat<sup>\u00ae<\/sup> (RMT), a new propellant-free soft mist inhaler, which is equivalent in terms of efficacy and safety to 1 puff of either 100 or 200\u00a0\u00b5g fenoterol inhaled from a conventional CFC-MDI (Berotec<sup>\u00ae<\/sup>). <i>Methods:<\/i> Sixty-two asthmatic patients (35 male, 27 female) with a mean baseline FEV<sub>1<\/sub> of 1.7 liters, corresponding to 55% of the predicted normal value, were randomized at two study centers to 4 of a total of 8 possible treatments: placebo; 12.5, 25, 50, 100, or 200\u00a0\u00b5g fenoterol via RMT, and 100 or 200\u00a0\u00b5g fenoterol delivered via the MDI. <i>Results:<\/i> Fifty-nine patients completed the study as planned. Results of the therapeutic equivalence test for the primary endpoint, average FEV<sub>1<\/sub> (AUC<sub>0\u20136<\/sub>)\/6 and for the secondary endpoint, peak FEV<sub>1<\/sub>, showed that the 12.5- and 25-\u00b5g fenoterol doses administered via RMT were equivalent to the 100\u00a0\u00b5g fenoterol dose from the MDI. The 50-, 100- and 200-\u00b5g fenoterol doses delivered by RMT did not meet the criterion for therapeutic equivalence with the 100-\u00b5g dose from the MDI, and if tested for a difference would have been significantly different in favor of RMT. All 5 RMT fenoterol doses were therapeutically equivalent to the MDI 200-\u00b5g fenoterol dose. Headache, reported by 4 patients on test days and 2 patients between test days in those randomized to RMT, was the most common adverse event, but the active treatments were generally well tolerated with no dose-dependent increases in incidence or severity of adverse events observed. <i>Conclusions:<\/i> The results from the study suggest that safe and efficacious bronchodilation can be obtained from single-dose fenoterol administered via RMT. Use of lower absolute doses to obtain a clinically significant improvement in pulmonary function may be possible because of the increased lung deposition achievable with the novel soft mist inhaler.<\/jats:p>","DOI":"10.1159\/000056298","type":"journal-article","created":{"date-parts":[[2003,4,15]],"date-time":"2003-04-15T19:06:20Z","timestamp":1050433580000},"page":"672-678","source":"Crossref","is-referenced-by-count":15,"title":["Delivery of Fenoterol via Respimat<sup>\u00ae<\/sup>, a Novel \u2018Soft Mist\u2019 Inhaler"],"prefix":"10.1159","volume":"67","author":[{"given":"Jan A.","family":"van Noord","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph J.","family":"Smeets","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacques P.H.M.","family":"Creemers","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louis P.M.","family":"Greefhorst","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen","family":"Dewberry","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Piet J.G.","family":"Cornelissen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"127","published-online":{"date-parts":[[2000,12,15]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1021\/js950522q"}],"container-title":["Respiration"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/56298","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/56298","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,24]],"date-time":"2025-04-24T04:46:45Z","timestamp":1745470005000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000056298"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2000]]},"references-count":1,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2000,12,1]]}},"URL":"https:\/\/doi.org\/10.1159\/000056298","archive":["Portico"],"relation":{},"ISSN":["0025-7931","1423-0356"],"issn-type":[{"type":"print","value":"0025-7931"},{"type":"electronic","value":"1423-0356"}],"subject":[],"published":{"date-parts":[[2000]]}}}