Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

Pharmacokinetic Pilot Study Comparing Absorption of Inhaled Tiotropium Between Tiotropium Easyhaler® Products and Spiriva® Capsules Delivered Via HandiHaler®

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03400241

Enrollment

Registered

2018-01-17

Start date

2018-02-19

Completion date

2018-04-18

Last updated

2018-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

Absorption of inhaled tiotropium is compared between three Tiotropium Easyhaler products and Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single dose.

Interventions

DRUGTiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 mcg/dose Product A

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female subjects * 18-60 years old * Body mass index \>19 and \<30 kg/m2 * Weight at least 50 kg * Written informed consent obtained

Exclusion criteria

* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease. * Any condition requiring regular concomitant treatment. * Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject. * Known hypersensitivity to tiotropium bromide, atropine or its derivatives, or lactose. * Pregnant or lactating females and females of childbearing potential not using proper contraception. * Blood donation, loss of a significant amount of blood or administration of another investigational medicinal product within 90 days before the first study treatment administration

Design outcomes

Primary

Measure	Time frame
Peak plasma concentration (Cmax) of tiotropium	between 0-72 hours after dosing
Area under the concentration-time curve (AUC) of tiotropium from time zero to 72 h after the study treatment administration	0-72 hours after dosing
Truncated area under the concentration-time curve (AUC) of tiotropium from time zero to 30 min after study treatment administration	0-30 minutes after dosing

Secondary

Measure	Time frame
Time to reach peak concentration in plasma (tmax) of tiotropium	between 0-72 hours after dosing

Other

Measure	Time frame
Adverse events	throughout the study, an average of 10 weeks

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026