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A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2B, 28-Day, Randomized, Double-Blind Placebo-Controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

NCT02040792•Mylan Inc.

View on ClinicalTrials.gov

Summary

This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is a male or female subject 40 years of age or older
•Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
•Subject is capable of performing reproducible spirometry maneuvers
•Subject has post-bronchodilator FEV1/FVC ratio \<0.7
•Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
•Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
•Subject has a current or past smoking history of at least 10 pack-years.

Exclusion Criteria

•Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
•Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
•Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
•Subject has been hospitalized for COPD or pneumonia within 12 weeks
•Subject requires long-term oxygen therapy (\>15 hours a day)

Locations (1)

Upstate Pharmaceutical Research

Greenville, South Carolina, United States

Key Dates

Start Date

May 1, 2014

Primary Completion Date

July 1, 2014

Completion Date

August 1, 2014

Last Updated

February 24, 2022

Enrollment

355

ACTUAL participants

Conditions

COPD

Interventions

TD-4208

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

Effect of Telenursing on Oral Health

Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

Probiotics in Pulmonaty Rehabilitation for COPD

Effects of Eccentric Exercise Training in Patients With COPD

Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3