Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Tiotropium Bromide Monohydrate

• Registration Number: NCT05246046
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

This is a pivotal study to investigate absorption of inhaled tiotropium from 2 Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-07
• Study Start: 2022-02-16
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-18
• Status Verified: 2022-08
• Primary Completion: 2022-08-03
• Study Completion: 2022-08-03
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tiotropium Easyhaler 10 microg/dose, Product variant K	Tiotropium Bromide Monohydrate	Each subject will receive a single dose of 2 inhaled doses from Tiotropium Easyhaler Product variant K in one of the three periods (cross-over). The total dose is 20 micrograms of tiotropium (delivered dose) as Tiotropium Bromide Monohydrate.
Spiriva HandiHaler 18 microg/capsule	Tiotropium Bromide Monohydrate	Each subject will receive a single dose of 2 inhaled Spiriva capsules via HandiHaler device in one of the three periods (cross-over). The total dose is 20 micrograms of tiotropium (delivered dose) as Tiotropium Bromide Monohydrate.
Tiotropium Easyhaler 10 microg/dose, Product variant J	Tiotropium Bromide Monohydrate	Each subject will receive a single dose of 2 inhaled doses from Tiotropium Easyhaler Product variant J in one of the three periods (cross-over). The total dose is 20 micrograms of tiotropium (delivered dose) as Tiotropium Bromide Monohydrate.

Primary Outcome Measures

Name	Time	Method
Peak tiotropium concentration in plasma (Cmax)	between 0-72 hours after dosing
Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)	between 0-30 minutes after dosing
Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)	between 0-72 hours after dosing

Secondary Outcome Measures

Name	Time	Method
Time to reach peak concentration in plasma (tmax)	between 0-72 hours after dosing

Trial Locations

Locations (1)

Clinical Pharmacology Unit, Orion Corporation; 🇫🇮 Espoo, Finland