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CompletedNCT05246046TEMPOUpdated Aug 18, 2022

Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler

A Phase 1 interventional study of Tiotropium Bromide Monohydrate in Healthy Volunteers, sponsored by Orion Corporation, Orion Pharma. Completed at 1 site in Finland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-18.

Sponsored by Orion Corporation, Orion Pharma · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Main inclusion criteria:

  1. Healthy male and female
  2. 18-60 years of age
  3. Body mass index 19-30 kg/m2
  4. Weight at least 50 kg
  5. FEV1 at least 80% of the predicted value measured at screening
  6. Written informed consent obtained

Main exclusion criteria:

  1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
  2. Any condition requiring regular concomitant treatment.
  3. Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject.
  4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or lactose.
  5. Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness.
  6. Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Tiotropium Easyhaler 10 microg/dose, Product variant J

    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.

    Drug: Tiotropium Bromide Monohydrate

  • Experimental
    Tiotropium Easyhaler 10 microg/dose, Product variant K

    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.

    Drug: Tiotropium Bromide Monohydrate

  • Active comparator
    Spiriva HandiHaler 18 microg/capsule

    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.

    Drug: Tiotropium Bromide Monohydrate

Interventions

  • DrugTiotropium Bromide Monohydrate

    In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler

    Also known as: Tiotropium Easyhaler 10 microg/dose, inhalation powder, Product variant J, Tiotropium Easyhaler 10 microg/dose, inhalation powder, Product variant K, SPIRIVA® 18 microgram, inhalation powder, hard capsule inhaled via HandiHaler

06

What researchers measure

Primary outcomes

  1. Peak tiotropium concentration in plasma (Cmax)

    Time frame: between 0-72 hours after dosing

  2. Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)

    Time frame: between 0-30 minutes after dosing

  3. Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)

    Time frame: between 0-72 hours after dosing

Secondary outcomes

  1. Time to reach peak concentration in plasma (tmax)

    Time frame: between 0-72 hours after dosing

Other outcomes

  1. Adverse events

    Time frame: throughout the study, an average 7 weeks

07

Study locations

1 site
  • Clinical Pharmacology Unit, Orion Corporation
    Espoo, Finland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05246046
Lead sponsor
Orion Corporation, Orion Pharma
Responsible party
Sponsor
First posted
Feb 18, 2022
Start date
Feb 16, 2022
Primary completion
Aug 3, 2022
Completion
Aug 3, 2022
Last update
Aug 18, 2022

Study contacts

Orion Corporation Clinical Study Director
study director · Orion Corporation, Orion Pharma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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