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trospium chloride

Phase 1

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

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

Clinical trial landscape

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 Chronic Obstructive Pulmonary Disease?

Trospium chloride is an investigational small molecule being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is formulated as an inhalation powder and was evaluated in a Phase 1 clinical trial in patients with COPD. The drug is still in clinical development and is not approved for this use.

Who makes trospium chloride?

Trospium chloride is being developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALKS. The company conducted a Phase 1 clinical trial of the drug as an inhalation powder for Chronic Obstructive Pulmonary Disease.

What phase is trospium chloride in?

Trospium chloride is in Phase 1 clinical development for Chronic Obstructive Pulmonary Disease. It has completed one Phase 1 trial, which enrolled 24 participants. The drug remains investigational and has not received FDA approval for any indication.

What clinical trials is trospium chloride in?

Trospium chloride has one completed clinical trial, NCT00465959, titled "Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease." This Phase 1, randomized, double-blind, placebo-controlled trial enrolled 24 participants in the United States.

Is trospium chloride the same as TrIP?

In clinical trial NCT00465959, trospium chloride is referred to as TrIP, which stands for Trospium Chloride Inhalation Powder. This is the formulation used in the Phase 1 study for Chronic Obstructive Pulmonary Disease. The drug is also known by its generic name, trospium chloride.