CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 641 enrolled
Drug / intervention
SUN-101 50 mcg BID eFlow (CS) nebulizer +2 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/NCT02347774
NCT02347774Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-4 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer

Sunovion Respiratory Development Inc.·interventional·Posted Jan 27, 2015·Updated Mar 13, 2018

In Brief

A Phase 3 clinical trial evaluating SUN-101 50 mcg BID eFlow (CS) nebulizer, SUN-101 25 mcg BID eFlow (CS) nebulizer, and 1 other intervention for COPD and Chronic Obstructive Pulmonary Disease. Completed, enrolled 641 participants across 45 sites.

Detailed Summary

This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD, Chronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 27, 2015
Enrollment StartFeb 1, 2015
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.4 years ago

Interventions

SUN-101 50 mcg BID eFlow (CS) nebulizerdrug

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

SUN-101 25 mcg BID eFlow (CS) nebulizerdrug

SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizerdrug

Placebo BID eFlow (R) Closed System (CS) nebulizer