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A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD

NCT02038829 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2018-04-10

Study results available
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Summary

Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg 2x a day will be given as an active comparator.

Conditions

Interventions

DRUG

Placebo

Placebo

DRUG

SUN101 3 mcg

SUN-101 3 mcg bid

DRUG

SUN-101 6.25 mcg

SUN-101 6.25 mcg bid

DRUG

SUN-101 12.5 mcg

SUN-101 12.5 mcg bid

DRUG

SUN-101 50 mcg

SUN-101 50 mcg bid

DRUG

Aclidinium

Aclidinium 400 mcg bid

Sponsors & Collaborators

  • Sunovion Respiratory Development Inc.

    lead INDUSTRY

Principal Investigators

  • SUN101 Medical Director, MD · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-05-31
Completion
2014-05-31

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 NCT02038829 on ClinicalTrials.gov