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Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4)

NCT02347774 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 641

Last updated 2018-03-13

Study results available
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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.

Conditions

Interventions

DRUG

SUN-101 50 mcg BID eFlow (CS) nebulizer

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

DRUG

SUN-101 25 mcg BID eFlow (CS) nebulizer

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

DRUG

Placebo eFlow (CS) nebulizer

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

Sponsors & Collaborators

  • Sunovion Respiratory Development Inc.

    lead INDUSTRY

Principal Investigators

  • Respiratory Medical Director, MD · Sunovion Respiratory Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02347774 on ClinicalTrials.gov