Phase 2
Completed N=64
A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT02109172 ↗Enrolled (actual)
64
Serious AEs
0.5%
Results posted
Dec 2016
Primary outcomePrimary: Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second) — -14.4; 90.2; 98.5 mL
Summary
This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second) |
-14.4; 90.2; 98.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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 (forced expiratory volume in 1 second/forced vital capacity) ratio 15 hours a day)
Data sourced from ClinicalTrials.gov (NCT02109172). 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.