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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.

Feifel U, Wallenstein G, Rominger KL, Trommeshauser D, Platz J - Int J Chron Obstruct Pulmon Dis (2008)

Bottom Line: Tiotropium Respimat SMI at doses up to 32 microg was well tolerated in Study 1; typical dose-dependent anticholinergic adverse events of mild-to-moderate intensity were observed.Tiotropium Respimat SMI was well tolerated.Inadvertent ocular exposure to tiotropium up to 0.40 g is unlikely to result in ocular adverse effects.

View Article: PubMed Central - PubMed

Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173,55216 Ingelheim, Germany. Ulrich.feifel@ing.boehringer-ingelheim.com

ABSTRACT
Data are presented from two randomized, double-blind, placebo-controlled studies in which the tolerability of tiotropium Respimat Soft MistTM Inhaler (SMI), a new-generation, propellant-free device for use in COPD, and the ocular safety oftiotropium were examined. In Study 1, 36 healthy males received tiotropium 8, 16, or 32 microg (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 microg (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 microg 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 g is unlikely to result in ocular adverse effects.

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Related in: MedlinePlus

Geometric mean cumulative tiotropium urinary excretion fraction on days 1, 7, and 14 after once-daily inhalation of tiotropium 8, 16, or 32 μg via Respimat® (n = 9/dose) (Study 1)
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f3-copd-3-397: Geometric mean cumulative tiotropium urinary excretion fraction on days 1, 7, and 14 after once-daily inhalation of tiotropium 8, 16, or 32 μg via Respimat® (n = 9/dose) (Study 1)

Mentions: The cumulative amount of urinary tiotropium excreted (in percent of dose) remained similar between doses on each day; approximately 25% of the dose was excreted at steady state (Figure 3). The fraction excreted in urine within 24 hours (Ae0–24h) increased between day 1 and day 7 by a factor of about 2–3, but remained similar on day 14 compared with day 7. The majority of the urine excretion occurred within the first sampling interval (0–4 hours).


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.

Feifel U, Wallenstein G, Rominger KL, Trommeshauser D, Platz J - Int J Chron Obstruct Pulmon Dis (2008)

Geometric mean cumulative tiotropium urinary excretion fraction on days 1, 7, and 14 after once-daily inhalation of tiotropium 8, 16, or 32 μg via Respimat® (n = 9/dose) (Study 1)
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2629989&req=5

f3-copd-3-397: Geometric mean cumulative tiotropium urinary excretion fraction on days 1, 7, and 14 after once-daily inhalation of tiotropium 8, 16, or 32 μg via Respimat® (n = 9/dose) (Study 1)
Mentions: The cumulative amount of urinary tiotropium excreted (in percent of dose) remained similar between doses on each day; approximately 25% of the dose was excreted at steady state (Figure 3). The fraction excreted in urine within 24 hours (Ae0–24h) increased between day 1 and day 7 by a factor of about 2–3, but remained similar on day 14 compared with day 7. The majority of the urine excretion occurred within the first sampling interval (0–4 hours).

Bottom Line: Tiotropium Respimat SMI at doses up to 32 microg was well tolerated in Study 1; typical dose-dependent anticholinergic adverse events of mild-to-moderate intensity were observed.Tiotropium Respimat SMI was well tolerated.Inadvertent ocular exposure to tiotropium up to 0.40 g is unlikely to result in ocular adverse effects.

View Article: PubMed Central - PubMed

Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173,55216 Ingelheim, Germany. Ulrich.feifel@ing.boehringer-ingelheim.com

ABSTRACT
Data are presented from two randomized, double-blind, placebo-controlled studies in which the tolerability of tiotropium Respimat Soft MistTM Inhaler (SMI), a new-generation, propellant-free device for use in COPD, and the ocular safety oftiotropium were examined. In Study 1, 36 healthy males received tiotropium 8, 16, or 32 microg (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 microg (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 microg 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 g is unlikely to result in ocular adverse effects.

Show MeSH
Related in: MedlinePlus