Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study

ClinicalTrials.gov ID: NCT01426009

Public ClinicalTrials.gov record NCT01426009. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 24, 2026, 3:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Seven Arm, Four-Period Cross-over, Incomplete Block Design, 7-Day Dosing Study to Assess the Dose-Response, Safety, and Efficacy of EP-101 (SUN101) in Subjects With Moderate to Severe COPD

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine steady-state efficacy and dose response profile and to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day dosing using an investigational high efficiency nebulizer (eFlow®) compared with placebo and two active comparators in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Study identification

NCT ID: NCT01426009
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Sunovion Respiratory Development Inc.; Industry
Enrollment: 140 participants

Conditions and interventions

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Drug

Eligibility (public fields only)

Age range: 40 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 2011 (Type not available)
Primary completion: Dec 2011 (Actual)
Completion: Dec 2011 (Actual)
Last update posted: May 9, 2018

2011

United States locations

U.S. sites: 10
U.S. states: 9
U.S. cities: 10

Facility	City	State	ZIP	Site status
Elevation Investigational Site	Phoenix	Arizona	85006	—
Elevation Investigational Site	Los Angeles	California	90048	—
Elevation Investigational Site	DeLand	Florida	32720	—
Elevation Investigational SIte	Madisonville	Kentucky	42431	—
Elevation Investigational Site	North Dartmouth	Massachusetts	02747	—
Elevation Investigational Site	Charlotte	North Carolina	28207	—
Elevation Investigational Site	Raleigh	North Carolina	27607	—
Elevation Investigational Site	Medford	Oregon	97504	—
Elevation Investigational Site	Spartanburg	South Carolina	29303	—
Elevation Investigational Site	Tacoma	Washington	98418	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01426009, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 9, 2018 · Synced Oct 24, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01426009 live on ClinicalTrials.gov.

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