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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

NCT01426009 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-05-09

Study results available
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Summary

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).

Conditions

Interventions

DRUG

EP-101 via nebulizer (eFlow®) 25 ug

EP-101 (25 ug ) Dose 1 administered once daily for 7 days

DRUG

EP-101 via nebulizer (eFlow®) 50 ug

EP-101 (50 ug ) administered once daily for 7 days

DRUG

EP-101 via nebulizer (eFlow®) 100 ug

EP-101 (100ug) administered once daily for 7 days

DRUG

Placebo EP-101

Placebo EP-101 administered once daily for 7 days

DRUG

Tiotropium bromide via (Spiriva® Handihaler®)

Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI

DRUG

Ipratropium bromide Inhalation Solution via Handihaler® DPI

Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer

DRUG

EP-101 via nebulizer (eFlow®) 200 ug

EP-101 (200) ug administered once daily for 7 days

Sponsors & Collaborators

  • Sunovion Respiratory Development Inc.

    lead INDUSTRY

Principal Investigators

  • Ahmet Tutuncu, M.D., Ph.D. · Chief Medical Officer / Elevation Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • United Kingdom

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 NCT01426009 on ClinicalTrials.gov