CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
TD-4208 700 μg or 350 μg single doseAI-extracted
Key inclusion· 3
  • ✓Diagnosis of moderate stable COPD with FEV1/FVC <0.7 at screening
  • ✓Current or past smoking history >10 pack-years
  • ✓Capable of performing reproducible spirometry maneuvers
Key exclusion· 8
  • ✕History of significant respiratory disease other than COPD and/or requires daily long-term oxygen therapy
  • ✕COPD exacerbation or lung infection within 6 weeks prior to study
  • ✕Start of or change in dose of COPD treatment within 4 weeks before study
  • ✕Daily use of high-dose maintenance corticosteroids (>1000 μg fluticasone propionate equivalent or >5 mg prednisone)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03064113
NCT03064113Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-Blind, Crossover Study to Examine the Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Single Doses of TD-4208 in Subjects Diagnosed With Chronic Obstructive Pulmonary Disease

Mylan Inc.·interventional·Posted Feb 24, 2017·Updated Feb 24, 2022

In Brief

A Phase 2 clinical trial evaluating Placebo, TD-4208 700 μg, and 2 other interventions for Chronic Obstructive Pulmonary Disease, COPD. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease, COPD
CountriesNew Zealand
CollaboratorsTheravance Biopharma

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2017
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.4 years ago

Interventions

Placebodrug

TD-4208 700 μgdrug

TD-4208 350 μgdrug

Ipratropium 500 μgdrug