Phase 2
N=32
Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease, COPD
Bottom Line
View on ClinicalTrials.gov: NCT03064113 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Peak Forced Expiratory Volume in One Second (FEV1) Relative to Baseline — 1708.0; 1877.3; 1881.8; 1883.6 mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); TD-4208 700 μg (Drug); TD-4208 350 μg (Drug); Ipratropium 500 μg (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Mylan Inc.
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Forced Expiratory Volume in One Second (FEV1) Relative to Baseline |
1708.0; 1877.3; 1881.8; 1883.6 | <0.001 sig |
| SECONDARY Area Under the FEV1 vs. Time Curve, Time-matched Difference From Placebo |
1519.2; 1642.6; 1631.7; 1534.5; 1533.8; 1670.4 | 0.001 sig |
| SECONDARY Area Under the FEV1 vs. Peak FEV1, Time-matched Difference From Placebo |
262.1; 291.2; 288.5; 287.7; 261.2; 286.6 | <0.001 sig |
| SECONDARY Peak Expiratory Flow Rate (PEFR) From 25% to 75% of Vital Capacity (FEF25-75), as Related to FEV1 |
0.8; 0.9; 0.9; 0.9; 0.8; 0.9 | 0.003 sig |
| SECONDARY Forced Expiratory Flow From 25% to 75% of Vital Capacity (FEF25-75), as Related to FEV1 |
0.6; 0.7; 0.7; 0.6; 0.6; 0.6 | 0.054 |
| SECONDARY Forced Vital Capacity (FVC) |
2941.9; 2949.1; 2986.7; 2959.4; 2873.4; 3166.9 | — |
| SECONDARY Area Under the Forced Vital Capacity (FVC) vs. Time Curve |
74168.1; 80057.0; 78143.6; 76822.7 | <0.001 sig |
Summary
Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and completed the follow-up assessments. During each of the four study periods, subjects were admitted to the clinic on Day -1 and housed overnight until after the last spirometry measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after evaluations.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of moderate stable Chronic Obstructive Pulmonary.
- Disease with FEV1/FVC 10 pack-years.
- Must be capable of performing reproducible spirometry maneuvers.
Exclusion Criteria
- History of significant respiratory disease other than COPD, and/ or requires daily long-term oxygen therapy.
- Exacerbation of COPD, lung infection within 6 weeks prior to study.
- Start of or change in dose of COPD treatment 4 weeks before study.
- Daily using of maintenance systemic/inhaled corticosteroids (>1000 microgram of fluticasone propionate equivalent or >5 mg prednisone).
- Use of bronchodilators or medication for the treatment of COPD, aspirin, anti-inflammatories for a specific time, prior to the first dose or is not willing to abstain from their use for the specified time periods prior to study dose administration.
- Symptomatic prostrate hypertrophy, bladder neck obstruction, active cancer, narrow angle glaucoma.
- Clinical significant hypersensitivity to medications.
- Participants have an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine or other disease that may place participant at risk.
- Cerebrovascular, cardiovascular disease or abnormal ECG.
- History of drug or alcohol abuse.
Data sourced from ClinicalTrials.gov (NCT03064113). 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.