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NCT00424528 · ClinicalTrials.gov registry record · Phase 4

Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 study, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 4
Development phase
235
Enrollment target

NCT00424528: Completed Phase 4 study, sponsored by Sumitomo Pharma America.

NCT00424528 is a Phase 4 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 235 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00424528, a Phase 4 study, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 4
Development phase
235 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Interventions

  • DRUG Placebo
  • DRUG Tiotropium
  • DRUG Arformoterol Tartrate Inhalation Solution
  • DRUG Arformoterol and Tiotropium

Trial Details

FieldValue
Enrollment Target 235 participants
Start Date 2006-12
Est. Completion 2007-10
Phase Phase 4
Sumitomo Pharma America

168 total trials

What the finished NCT00424528 record still lists

NCT00424528 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00424528 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00424528 about?

NCT00424528 is a clinical study titled "Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)". The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).

What is the current status of trial NCT00424528?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 235 participants. The study started on 2006-12. Estimated completion is 2007-10.

What interventions are being tested in trial NCT00424528?

The interventions under investigation include: Placebo (DRUG), Tiotropium (DRUG), Arformoterol Tartrate Inhalation Solution (DRUG), Arformoterol and Tiotropium (DRUG).

Who is sponsoring clinical trial NCT00424528?

This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00424528's enrollment target sits among peer trials

235 369th of 2000 higher than 1,632 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT00424528, the US trial registry maintained by the National Library of Medicine. NCT00424528 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.