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trospium chloride

Phase 4FDA approved

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |Alkermes plc|Trials Updated: Dec 27, 2013

trospium chloride development status

FDA approval on record May 28, 2004
Approval holderAllergan
ApplicationNDA021595
Highest phase Phase 4 run by Allergan (NCT00863551)
Phase scored for ALKSPhase 1
Registered trials 6 across 3 sponsors since Mar 2009

trospium chloride target and mechanism

Molecular targetCHRM2, CHRM3
Target classAntagonist
ModalitySmall molecule

Also known as trospium chloride inhalation powder (TrIP)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

trospium chloride clinical trials

trospium chloride · 1 trial · 1 indication

Phase 1 1
NCT00465959Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disease
COMPLETED24 Analytics
PHASE1COMPLETED
Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
400 mg TrIPEXPERIMENTAL -
800 mg TrIPEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
trospium chloride inhalation powder (TrIP)DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female COPD patients between the ages of 40 and 80 years * Smoking history of at least 10 pack years * Not currently using (or able to wash out of) any long acting bronchodilators Exclusion Criteria: * Candidate on a waiting list for surgery while on study * Using lo...

Countries:United States
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Frequently asked questions about trospium chloride

What is trospium chloride used for in COPD?

Trospium chloride is being developed as an inhalation powder for chronic obstructive pulmonary disease, or COPD. The inhaled formulation, called trospium chloride inhalation powder (TrIP), is designed to deliver the drug directly to the lungs. It is investigational and has been studied in a Phase 1 trial in patients with COPD.

What does trospium chloride target?

Trospium chloride targets the muscarinic acetylcholine receptors CHRM2 and CHRM3, where it acts as an antagonist. By blocking these receptors, it is intended to reduce cholinergic signaling in the airways, which is relevant to conditions such as COPD. This mechanism is the basis for its development as an inhaled therapy.

Who is developing trospium chloride inhalation powder?

Trospium chloride inhalation powder (TrIP) is being developed by Alkermes plc, which trades on the Nasdaq under the ticker ALKS. The company is responsible for the clinical program evaluating this inhaled formulation in patients with chronic obstructive pulmonary disease.

What phase is trospium chloride inhalation powder in?

Trospium chloride inhalation powder (TrIP) is in Phase 1 clinical development. It has completed one Phase 1 trial in patients with chronic obstructive pulmonary disease. It is an investigational product and has not been approved by the FDA for any indication.

What clinical trials is trospium chloride inhalation powder in?

Trospium chloride inhalation powder (TrIP) has been studied in a single completed Phase 1 trial, NCT00465959, titled "Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease." The trial enrolled 24 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is trospium chloride the same as trospium chloride inhalation powder (TrIP)?

Trospium chloride inhalation powder (TrIP) is an inhaled formulation of trospium chloride. The active drug is trospium chloride, a small molecule muscarinic antagonist, while TrIP refers specifically to the inhalation powder version developed by Alkermes for chronic obstructive pulmonary disease. They are not separate drugs but different formulations of the same active ingredient.