At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,071 enrolled
Drug / intervention
Perforomist-Placebo +1 moredrug
Likely dose
Perforomist-Placebo 2mLfrom 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.
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate) Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 4 clinical trial evaluating Perforomist-Placebo and Perforomist, nebulization, COPD for COPD. Completed, enrolled 1,071 participants across 1 site.
Detailed Summary
This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartMar 2012
Primary CompletionJan 2016
TodayJul 2026
First PostedDec 8, 2011
Enrollment StartMar 1, 2012
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.6 years ago
Interventions
Perforomist-Placebodrug
Placebo vehicle, 2mL, twice daily for 52 weeks
Perforomist, nebulization, COPDdrug
Perforomist, 20 mcg/2 mL, twice daily for 52 weeks