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tiotropium pMDI

Phase 1

Undisclosed | Small molecule | Other |Solventum Corporation|Trials Updated: Dec 2, 2024

tiotropium pMDI development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2017

tiotropium pMDI target and mechanism

Molecular targetCHRM3
Target classAntagonist
ModalitySmall molecule

Also known as Spiriva Respimat

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

tiotropium pMDI clinical trials

tiotropium pMDI · 1 trial · 1 indication

Early Phase 1 1
NCT03155204Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference ProductHealthy
COMPLETED46 Analytics
EARLY_PHASE1COMPLETED
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product
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Study Endpoints

Primary Endpoints

Peak Plasma Concentration (Cmax)
24 hr

noncompartmental analysis

Secondary Endpoints

Adverse events
24 hr
Area Under the Plasma Concentration vs Time Curve (AUC)
24 hr
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Test Product 1EXPERIMENTALtiotropium pMDI 2 inhalations
Test Product 2EXPERIMENTALtiotropium pMDI 2 inhalations
Test Product 3EXPERIMENTALtiotropium pMDI 2 inhalations
Test Product 4EXPERIMENTALtiotropium pMDI 2 inhalations
Commercial ProductACTIVE_COMPARATORtiotropium Respimat 2 inhalations

Interventions

NameTypeDescription
tiotropium pMDIDRUGinhalation
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Volunteer * Willing and able to give informed consent * Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic * Subjects must agree to use an adequate method of contraception ...

Countries:United Kingdom
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Frequently asked questions about tiotropium pMDI

What is tiotropium pMDI?

Tiotropium pMDI is an investigational pressurized metered dose inhaler formulation of tiotropium, a small molecule drug being developed by Solventum Corporation. It is in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed.

What does tiotropium pMDI target?

Tiotropium pMDI targets CHRM3, the muscarinic acetylcholine receptor M3. It acts as an antagonist at this receptor. By blocking CHRM3, the drug is designed to interfere with cholinergic signaling, which is a mechanism relevant to airway function.

Who is developing tiotropium pMDI?

Tiotropium pMDI is being developed by Solventum Corporation, which trades under the ticker SOLV. The company is responsible for the clinical development of this inhaler product.

What phase is tiotropium pMDI in?

Tiotropium pMDI is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. One early Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is tiotropium pMDI in?

Tiotropium pMDI has been studied in one completed clinical trial, NCT03155204, titled Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product. The trial enrolled 46 healthy volunteers in the United Kingdom and was active-controlled and randomized.