Phase 2
Completed N=354
A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT02040792 ↗Enrolled (actual)
354
Serious AEs
1.1%
Results posted
Dec 2016
Primary outcomePrimary: Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second) — -32.4; 19.4; 155.0; 134.2 mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second) |
-32.4; 19.4; 155.0; 134.2; 138.2 | — |
Eligibility Criteria
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 15 hours a day)
Data sourced from ClinicalTrials.gov (NCT02040792). 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.