CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
TrIP-2D 100 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00801684
NCT00801684Phase 2Completed
CompareCT.gov

Efficacy, Safety, Tolerability, and Pharmacokinetics of Trospium Inhalation Powder (TrIP) Administered to Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Alkermes, Inc.·interventional·Posted Dec 3, 2008·Updated Aug 19, 2011

In Brief

A Phase 2 clinical trial evaluating Placebo, TrIP-2D, and 2 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 24 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 3, 2008
Enrollment StartFeb 1, 2009
Primary CompletionApr 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.6 years ago

Interventions

Placebodrug

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

TrIP-2Ddrug

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.

TrIP-2SSdrug

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.

TrIP-2Ddrug

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.

TrIP-2SS + Foradildrug

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.