NCT05246046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2022

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

February 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

February 7, 2022

Last Update Submit

August 15, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Time to reach peak concentration in plasma (tmax)

    between 0-72 hours after dosing

Other Outcomes (1)

  • Adverse events

    throughout the study, an average 7 weeks

Study Arms (3)

Tiotropium Easyhaler 10 microg/dose, Product variant J

EXPERIMENTAL

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

Tiotropium Easyhaler 10 microg/dose, Product variant K

EXPERIMENTAL

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

Spiriva HandiHaler 18 microg/capsule

ACTIVE COMPARATOR

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

Tiotropium Bromide MonohydrateDRUG

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
Spiriva HandiHaler 18 microg/capsuleTiotropium Easyhaler 10 microg/dose, Product variant JTiotropium Easyhaler 10 microg/dose, Product variant K

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female
  • years of age
  • Body mass index 19-30 kg/m2
  • Weight at least 50 kg
  • FEV1 at least 80% of the predicted value measured at screening
  • Written informed consent obtained

You may not qualify if:

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, 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 could interfere with the interpretation of study results or cause 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 contraception of acceptable effectiveness.
  • Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology Unit, Orion Corporation

Espoo, Finland

Location

MeSH Terms

Interventions

Hardness

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • Orion Corporation Clinical Study Director

    Orion Corporation, Orion Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Bioanalytical laboratory will be blinded with regard to the sequence of the product administration
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 18, 2022

Study Start

February 16, 2022

Primary Completion

August 3, 2022

Study Completion

August 3, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)