Phase 2
Completed N=62
7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT01704404 ↗Enrolled (actual)
62
Serious AEs
1.0%
Results posted
Mar 2017
Primary outcomePrimary: Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second) — 91.2; 92.8; 113.1; 151.9 FEV1 (mL)
Summary
This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second) |
91.2; 92.8; 113.1; 151.9; 132.2; 119.4 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is a male or female between the ages of 40 and 75 years (inclusive, at randomization).
- Subject:
- Has an FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) 1000 μg of fluticasone propionate equivalent or ≥10 mg prednisone).
- Subject has an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine, or other disease or condition based on information gathered from the medical history, physical examination, or laboratory findings that might place the subject at undue risk or potentially compromise the results or interpretation of the study.
- Subject has a history of significant cerebrovascular disease, coronary artery disease, or cardiac arrhythmias. Subject has a history (or family history) of congenital prolonged QTc (corrected QT interval) syndrome or has an abnormal clinically significant electrocardiogram (ECG) at screening, including QTcB (QT interval corrected for heart rate using Bazett's formula) value >450 msec (males) or >470 msec (females); or shows evidence of clinically significant rhythm abnormality.
- Subject has a known hypersensitivity to TD-4208 or similar drug class.
- Subject has a history of alcoholism or drug abuse within 2 years prior to screening.
Data sourced from ClinicalTrials.gov (NCT01704404). 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.