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NCT00801684 · ClinicalTrials.gov registry record · Phase 2
ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD
A Phase 2 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00801684: Completed Phase 2 study, sponsored by Alkermes.
NCT00801684 is a Phase 2 study that has completed, run by Alkermes. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00801684, a Phase 2 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study 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).
Primary Outcome
Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. The dosing formulations were as follows: Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate) FEV1 (L)was measured at 15 and
Interventions
- DRUG Placebo
- DRUG TrIP-2D
- DRUG TrIP-2SS
- DRUG TrIP-2SS + Foradil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00801684 record still lists
NCT00801684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00801684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00801684 about?
NCT00801684 is a clinical study titled "ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD". 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).
What is the current status of trial NCT00801684?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2009-02. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00801684?
The interventions under investigation include: Placebo (DRUG), TrIP-2D (DRUG), TrIP-2SS (DRUG), TrIP-2SS + Foradil (DRUG).
Who is sponsoring clinical trial NCT00801684?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00801684's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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