Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

NCT04850144 — Phase 1, Completed, 43 participants, Orion Corporation, Orion Pharma

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Comparison of Tiotropium Pharmacokinetics After Inhalation From Tiotropium Easyhaler® Product Variants and After Spiriva® Capsules Administered Via HandiHaler®; Study in Healthy Volunteers

Registry	NCT04850144, acronym TESSA
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, basic science
Enrollment	43 (Actual)
Sponsor	Orion Corporation, Orion Pharma (Industry)
Conditions	Healthy Volunteers
Interventions	Tiotropium Bromide Monohydrate, Tiotropium Easyhaler with oral activated charcoal (Drug)
Dates	start 2021-04-26, primary completion 2021-10-04, completion 2021-10-04, first posted 2021-04-20, last updated 2021-10-25
Locations	1 site in Finland

-Summary

Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.

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+Arms and interventions

Arm	Type	Interventions
Tiotropium Easyhaler Product variant D	Experimental	Drug: Tiotropium Bromide Monohydrate
Tiotropium Easyhaler Product variant E	Experimental	Drug: Tiotropium Bromide Monohydrate
Tiotropium Easyhaler Product variant F	Experimental	Drug: Tiotropium Bromide Monohydrate
Tiotropium Easyhaler Product variant G	Experimental	Drug: Tiotropium Bromide Monohydrate
Tiotropium Easyhaler Product variant H	Experimental	Drug: Tiotropium Bromide Monohydrate
Spiriva HandiHaler	Active comparator	Drug: Tiotropium Bromide Monohydrate
Tiotropium Easyhaler Product variant F administered with oral activated charcoal	Experimental	Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Easyhaler with oral activated charcoal

Tiotropium Bromide Monohydrate (Drug): Tiotropium Easyhaler 10 µg/dose Product variant D
Tiotropium Bromide Monohydrate (Drug): Tiotropium Easyhaler 10 µg/dose Product variant E
Tiotropium Bromide Monohydrate (Drug): Tiotropium Easyhaler 10 µg/dose Product variant F
Tiotropium Bromide Monohydrate (Drug): Tiotropium Easyhaler 10 µg/dose Product variant G
Tiotropium Bromide Monohydrate (Drug): Tiotropium Easyhaler 10 µg/dose Product variant H
Tiotropium Bromide Monohydrate (Drug): Spiriva 18 µg/capsule inhaled via Handihaler
Tiotropium Easyhaler with oral activated charcoal (Drug): The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F

+Outcome measures

Primary outcomes

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) [0-30 minutes after dosing]
Area under the concentration-time curve from time zero to 72 hours (AUC72 hours) [0-72 hours after dosing]

Secondary outcomes

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

Other outcomes

Adverse events [througout the study, an average 9 weeks]

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

Main inclusion criteria:

1. Healthy males and females
2. 18-60 years of age
3. Body mass index 19-30 kg/m2
4. Weight at least 50 kg
5. Written informed consent obtained

Main exclusion criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, 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.

+Locations (1)

Facility	City	Country	Status
Clinical Pharmacology Unit, Orion Corporation	Espoo	Finland

+Investigators

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