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ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD

NCT00801684 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-08-19

Study results available
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Summary

The purpose of this study was to evaluate the efficacy, safety, and tolerability of single doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive pulmonary disease (COPD).

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Placebo

Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler.

DRUG

TrIP-2D

Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.

DRUG

TrIP-2SS

Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.

DRUG

TrIP-2D

Trospium inhalation powder containing 400 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.

DRUG

TrIP-2SS + Foradil

Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), plus foradil (12 mcg formoterol fumarate) supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Bernard L. Silverman, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-04-30
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00801684 on ClinicalTrials.gov