Phase 3
Completed N=611
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT02512510 ↗Enrolled (actual)
611
Serious AEs
3.8%
Results posted
Dec 2018
Primary outcomePrimary: Change From Baseline in Trough FEV1 on Day 85 — 115.58; 102.90; -44.92 mL
◆ Published Evidence
Emerging
6citations · ~1 / year
Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis.
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.
Linked Publications (4)
-
Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis.
-
Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease.
-
Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD.
-
Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough FEV1 on Day 85 |
115.58; 102.90; -44.92 | — |
| SECONDARY Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85 |
83.9; 87.1; -39.9 | — |
| SECONDARY Summary of Change From Baseline to Peak FEV1 After First Dose |
218.65; 216.84; 88.22 | — |
| SECONDARY Summary of Rescue Medication Use: Puffs Per Day |
2.00; 2.38; 2.54 | — |
| SECONDARY St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85 |
67; 67; 54 | — |
| SECONDARY Percentage of Albuterol Rescue-free 24-hour Periods |
44.79; 43.26; 37.23 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02512510) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.