Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler (TEMPO)

August 15, 2022 updated by: Orion Corporation, Orion Pharma

Pharmacokinetic Study to Compare Tiotropium Easyhaler® Product Variants and Spiriva® 18 µg Capsules Administered Via HandiHaler® in Healthy Volunteers.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Espoo, Finland
        • Clinical Pharmacology Unit, Orion Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler
Other Names:
  • 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
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
In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler
Other Names:
  • 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
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
In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to reach peak concentration in plasma (tmax)
Time Frame: between 0-72 hours after dosing
between 0-72 hours after dosing

Other Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: throughout the study, an average 7 weeks
throughout the study, an average 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2022

Primary Completion (Actual)

August 3, 2022

Study Completion (Actual)

August 3, 2022

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3122006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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