CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 235 enrolled
Drug / intervention
Arformoterol Tartrate Inhalation Solution +3 moredrug
Likely dose
Arformoterol Tartrate Inhalation Solution 15 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/NCT00424528
NCT00424528Phase 4Completed
CompareCT.gov

A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily, Tiotropium Once-Daily, and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once Daily in Subjects With Chronic Obstructive Pulmonary Disease

Sumitomo Pharma America, Inc.·interventional·Posted Jan 19, 2007·Updated Jun 4, 2012

In Brief

A Phase 4 clinical trial evaluating Arformoterol Tartrate Inhalation Solution, Tiotropium, and 2 other interventions for Chronic Obstructive Pulmonary Disease and 2 related conditions. Completed, enrolled 235 participants across 28 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease, Bronchitis, Emphysema
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 19, 2007
Enrollment StartDec 1, 2006
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.5 years ago

Interventions

Arformoterol Tartrate Inhalation Solutiondrug

Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.

Tiotropiumdrug

Placebo inhalation solution twice daily and tiotropium inhalation powder 18 mcg once daily.

Arformoterol and Tiotropiumdrug

Arformoterol tartrate inhalation solution 15 mcg twice daily and Tiotropium inhalation powder 18 mcg once daily.

Placebodrug

Placebo inhalation solution and placebo inhalation powder