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

Phase 2

Completed

• Conditions: COPD
• Interventions: Drug: TD-4208; Drug: Placebo

• Registration Number: NCT02040792
• Lead Sponsor: Mylan Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-20
• Study Start: 2014-05
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Results First Submitted: 2016-06-30
• Results First Submitted QC: 2016-10-13
• Results First Posted: 2016-12-07
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
175 mcg	TD-4208	TD-4208
350 mcg	TD-4208	TD-4208
Placebo	Placebo	Placebo
88 mcg	TD-4208	TD-4208
44 mcg	TD-4208	TD-4208

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)	Baseline to 28 days

Trial Locations

Locations (1)

Upstate Pharmaceutical Research; 🇺🇸 Greenville, South Carolina, United States