CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,087 enrolled
Drug / intervention
SUN-101 50 mcg BID eFlow (CS) nebulizer +1 moredrug
Likely dose
SUN-101 50 mcg BID eFlow (CS) nebulizerfrom 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/NCT02276222
NCT02276222Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter, Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-5 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

Sunovion Respiratory Development Inc.·interventional·Posted Oct 28, 2014·Updated Mar 13, 2018

In Brief

A Phase 3 clinical trial evaluating SUN-101 50 mcg BID eFlow (CS) nebulizer and Spiriva® 18 mcg QD Handihaler for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 1,087 participants across 118 sites in 4 countries.

Detailed Summary

This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® \[tiotropium\] given as 18 mcg once a day).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesCzechia, Hungary, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 28, 2014
Enrollment StartOct 1, 2014
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.7 years ago

Interventions

SUN-101 50 mcg BID eFlow (CS) nebulizerdrug

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva® 18 mcg QD Handihalerdrug

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler