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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512510
• Other study ID #: 0127
• Status: Completed
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• TD-4208

• Placebo

Locations

Country	Name	City	State
United States	Palmetto Medical Research Associates L.L.C.	Easley	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

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