Pharmacokinetics and tolerability (Study 1) with particular reference to ocular safety (Study 2) of tiotropium Respimat® Soft Mist™ Inhaler: findings from two dose-ranging studies in healthy men
Ulrich Feifel1, Gudrun Wallenstein1, Karl-Ludwig Rominger1, Dirk Trommeshauser2, Juliane Platz21Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim, Germany; 2Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorf Straße 65...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2008-10-01
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| Series: | International Journal of COPD |
| Online Access: | http://www.dovepress.com/pharmacokinetics-and-tolerability-study-1-with-particular-reference-to-a2452 |
| _version_ | 1818237278312464384 |
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| author | Ulrich Feifel Gudrun Wallenstein Karl-Ludwig Rominger Dirk Trommeshauser Juliane Platz |
| author_facet | Ulrich Feifel Gudrun Wallenstein Karl-Ludwig Rominger Dirk Trommeshauser Juliane Platz |
| author_sort | Ulrich Feifel |
| collection | DOAJ |
| description | Ulrich Feifel1, Gudrun Wallenstein1, Karl-Ludwig Rominger1, Dirk Trommeshauser2, Juliane Platz21Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim, Germany; 2Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorf Straße 65, 88397 Biberach, GermanyAbstract: Data are presented from two randomized, double-blind, placebo-controlled studies in which the tolerability of tiotropium Respimat® Soft Mist™ Inhaler (SMI), a new-generation, propellant-free device for use in COPD, and the ocular safety of tiotropium were examined. In Study 1, 36 healthy males received tiotropium 8, 16, or 32 µg (n = 9/dose) or placebo (n = 3/dose level), administered once daily via Respimat® SMI for 14 days. Safety and pharmacokinetics were evaluated. In Study 2, 48 healthy males received tiotropium 0.02, 0.04, 0.08, 0.16, 0.28, or 0.40 µg (n = 6/dose) or placebo (n = 2/dose level), applied as two drops to one eye (the highest dose was a significant multiple of a percentage of the proposed Respimat® SMI clinical dose that could be inadvertently deposited in the eye). Ocular parameters were measured over 24 hours. Tiotropium Respimat® SMI at doses up to 32 µg was well tolerated in Study 1; typical dose-dependent anticholinergic adverse events of mild-to-moderate intensity were observed. In Study 2, ocular tiotropium administration did not affect pupil diameter, pupillary reflex, intraocular pressure, or accommodation. Tiotropium Respimat® SMI was well tolerated. Inadvertent ocular exposure to tiotropium up to 0.40 µg is unlikely to result in ocular adverse effects.Keywords: Respimat® Soft Mist™ Inhaler, tiotropium, anticholinergic, chronic obstructive pulmonary disease |
| first_indexed | 2024-12-12T12:23:13Z |
| format | Article |
| id | doaj.art-d249ce5de77d4e0397179cb10f305721 |
| institution | Directory Open Access Journal |
| issn | 1176-9106 1178-2005 |
| language | English |
| last_indexed | 2024-12-12T12:23:13Z |
| publishDate | 2008-10-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | International Journal of COPD |
| spelling | doaj.art-d249ce5de77d4e0397179cb10f3057212022-12-22T00:24:37ZengDove Medical PressInternational Journal of COPD1176-91061178-20052008-10-012008Issue 3397403Pharmacokinetics and tolerability (Study 1) with particular reference to ocular safety (Study 2) of tiotropium Respimat® Soft Mist™ Inhaler: findings from two dose-ranging studies in healthy menUlrich FeifelGudrun WallensteinKarl-Ludwig RomingerDirk TrommeshauserJuliane PlatzUlrich Feifel1, Gudrun Wallenstein1, Karl-Ludwig Rominger1, Dirk Trommeshauser2, Juliane Platz21Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim, Germany; 2Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorf Straße 65, 88397 Biberach, GermanyAbstract: Data are presented from two randomized, double-blind, placebo-controlled studies in which the tolerability of tiotropium Respimat® Soft Mist™ Inhaler (SMI), a new-generation, propellant-free device for use in COPD, and the ocular safety of tiotropium were examined. In Study 1, 36 healthy males received tiotropium 8, 16, or 32 µg (n = 9/dose) or placebo (n = 3/dose level), administered once daily via Respimat® SMI for 14 days. Safety and pharmacokinetics were evaluated. In Study 2, 48 healthy males received tiotropium 0.02, 0.04, 0.08, 0.16, 0.28, or 0.40 µg (n = 6/dose) or placebo (n = 2/dose level), applied as two drops to one eye (the highest dose was a significant multiple of a percentage of the proposed Respimat® SMI clinical dose that could be inadvertently deposited in the eye). Ocular parameters were measured over 24 hours. Tiotropium Respimat® SMI at doses up to 32 µg was well tolerated in Study 1; typical dose-dependent anticholinergic adverse events of mild-to-moderate intensity were observed. In Study 2, ocular tiotropium administration did not affect pupil diameter, pupillary reflex, intraocular pressure, or accommodation. Tiotropium Respimat® SMI was well tolerated. Inadvertent ocular exposure to tiotropium up to 0.40 µg is unlikely to result in ocular adverse effects.Keywords: Respimat® Soft Mist™ Inhaler, tiotropium, anticholinergic, chronic obstructive pulmonary diseasehttp://www.dovepress.com/pharmacokinetics-and-tolerability-study-1-with-particular-reference-to-a2452 |
| spellingShingle | Ulrich Feifel Gudrun Wallenstein Karl-Ludwig Rominger Dirk Trommeshauser Juliane Platz Pharmacokinetics and tolerability (Study 1) with particular reference to ocular safety (Study 2) of tiotropium Respimat® Soft Mist™ Inhaler: findings from two dose-ranging studies in healthy men International Journal of COPD |
| title | Pharmacokinetics and tolerability (Study 1) with particular reference to ocular safety (Study 2) of tiotropium Respimat® Soft Mist™ Inhaler: findings from two dose-ranging studies in healthy men |
| title_full | Pharmacokinetics and tolerability (Study 1) with particular reference to ocular safety (Study 2) of tiotropium Respimat® Soft Mist™ Inhaler: findings from two dose-ranging studies in healthy men |
| title_fullStr | Pharmacokinetics and tolerability (Study 1) with particular reference to ocular safety (Study 2) of tiotropium Respimat® Soft Mist™ Inhaler: findings from two dose-ranging studies in healthy men |
| title_full_unstemmed | Pharmacokinetics and tolerability (Study 1) with particular reference to ocular safety (Study 2) of tiotropium Respimat® Soft Mist™ Inhaler: findings from two dose-ranging studies in healthy men |
| title_short | Pharmacokinetics and tolerability (Study 1) with particular reference to ocular safety (Study 2) of tiotropium Respimat® Soft Mist™ Inhaler: findings from two dose-ranging studies in healthy men |
| title_sort | pharmacokinetics and tolerability study 1 with particular reference to ocular safety study 2 of tiotropium respimat amp reg soft mist amp trade inhaler findings from two dose ranging studies in healthy men |
| url | http://www.dovepress.com/pharmacokinetics-and-tolerability-study-1-with-particular-reference-to-a2452 |
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