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A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT01706536 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2018-03-08

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.

Conditions

Interventions

DRUG

Placebo

EP-101 Placebo AM + EP-101 Placebo PM

DRUG

EP-101 12.5 mcg

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

DRUG

EP-101 25 mcg

EP-101 25 mcg AM + EP-101 25 mcg PM

DRUG

EP-101 50 mcg

EP-101 50 mcg AM + EP-101 50 mcg PM

DRUG

EP-101 100 mcg

EP-101 100 mcg AM + EP-101 100 mcg PM

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
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01706536 on ClinicalTrials.gov