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

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Tiotropium Bromide Monohydrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05246046

3122006

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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88 participants in 3 patient groups

Tiotropium Easyhaler 10 microg/dose, Product variant J

Experimental group

Description:

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.

Treatment:

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 microg/dose, Product variant K

Experimental group

Description:

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.

Treatment:

Drug: Tiotropium Bromide Monohydrate

Spiriva HandiHaler 18 microg/capsule

Active Comparator group

Description:

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.

Treatment:

Drug: Tiotropium Bromide Monohydrate