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Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease

Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00465959
Enrollment
24
Registered
2007-04-27
Start date
2007-04-30
Completion date
2007-06-30
Last updated
2013-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Brief summary

To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD

Interventions

DRUGtrospium chloride inhalation powder (TrIP)
DRUGPlacebo

Sponsors

Alkermes, Inc.
CollaboratorINDUSTRY
Endo Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years

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 long-term oxygen therapy * Hospitalization for COPD exacerbation

Design outcomes

Primary

MeasureTime frame
Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026