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A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

NCT02518139 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1060

Last updated 2022-02-24

Study results available
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Summary

The purpose of this study is to measure the safety and tolerability of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to tiotropium.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

TD-4208

Subjects receiving TD-4208 are blinded to one of two doses of 4208.

DRUG

Tiotropium

There is not a placebo, there is an active comparator (Tiotropium) arm.

Sponsors & Collaborators

  • Theravance Biopharma

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

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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 NCT02518139 on ClinicalTrials.gov