Phase 3
Completed N=1,055
A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT02518139 ↗Enrolled (actual)
1,055
Serious AEs
15.1%
Results posted
Dec 2018
Primary outcomePrimary: Adverse Events: Frequency and Severity — 272; 242; 275; 226 Participants
◆ Published Evidence
Established
38citations · ~5 / year
Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease.
Summary
The purpose of this study is to measure the safety and tolerability of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to tiotropium.
Linked Publications (4)
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Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease.
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Maintained therapeutic effect of revefenacin over 52 weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD).
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Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers.
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Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events: Frequency and Severity |
272; 242; 275; 226; 174; 210 | — |
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 (NCT02518139) 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.