Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
Phase 3
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT02512510
- Lead Sponsor
- Mylan Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 611
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TD-4208-1 TD-4208 88 mcg TD-4208-2 TD-4208 175 mcg Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Change From Baseline in Trough FEV1 on Day 85 Baseline and Day 85
- Secondary Outcome Measures
Name Time Method Summary of Change From Baseline to Peak FEV1 After First Dose 0-2 hours after First Dose Day 1 Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85 Days 15 to 85 Percentage of Albuterol Rescue-free 24-hour Periods 1-3 Months Summary of Rescue Medication Use: Puffs Per Day 1-3 Months St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85 Day 85 A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units
Trial Locations
- Locations (1)
Palmetto Medical Research Associates L.L.C.
🇺🇸Easley, South Carolina, United States