Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)

Overview

The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.

Full Title of Study: “A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 2016

Interventions

  • Drug: TD-4208
  • Drug: Placebo

Arms, Groups and Cohorts

  • Active Comparator: TD-4208-1
    • 88 mcg
  • Active Comparator: TD-4208-2
    • 175 mcg
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Trough FEV1 on Day 85
    • Time Frame: Baseline and Day 85

Secondary Measures

  • Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85
    • Time Frame: Days 15 to 85
  • Summary of Change From Baseline to Peak FEV1 After First Dose
    • Time Frame: 0-2 hours after First Dose Day 1
  • Summary of Rescue Medication Use: Puffs Per Day
    • Time Frame: 1-3 Months
  • St. George’s Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85
    • Time Frame: Day 85
    • A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units
  • Percentage of Albuterol Rescue-free 24-hour Periods
    • Time Frame: 1-3 Months

Participating in This Clinical Trial

Inclusion Criteria

  • Subject is a male or female subject 40 years of age or older

Exclusion Criteria

  • Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Theravance Biopharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Theravance Biopharma

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