An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients
NCT02315144 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61
Last updated 2021-11-09
Summary
The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV48108.
Conditions
Interventions
- DRUG
-
TV48108
TV48108 15, 60, 120 μg
- DRUG
-
Placebo Comparator
Sponsors & Collaborators
-
Teva Branded Pharmaceutical Products R&D, Inc.
lead INDUSTRY
Principal Investigators
-
Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-04-30
- Primary Completion
- 2015-08-31
- Completion
- 2015-08-31
Countries
- United States
- Australia
- New Zealand
Study Locations
More Related Trials
-
Bioequivalence Study of Tiotropium Bromide Inhalation Powder
NCT05161156 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
NCT02275481 ·Status: TERMINATED ·Phase: PHASE4
-
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02175342 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy Volunteers
NCT00914433 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers
NCT01818024 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)
NCT01854645 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment
NCT02172781 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT05986591 ·Status: COMPLETED ·Phase: PHASE3
-
Randomised, Double- Blind, Cross-over Efficacy and Safety Comparison of Three Different Doses of Tiotropium Administered Once Daily Versus Placebo in Patients With Moderate Persistent Asthma.
NCT01233284 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics and Safety Comparison of Tiotropium Inhalation Powder Administered as the Bromide Salt From Hard Polyethylene Capsule Via the HandiHaler® 2 and Spiriva® HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02242266 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Tiotropium on Airway Diameter in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02172391 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide in Healthy Male Volunteers
NCT02259959 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)
NCT00281567 ·Status: COMPLETED ·Phase: PHASE3
-
Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis
NCT02657473 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Phase 4 COPD and Suboptimal Inspiratory Flow Rate
NCT05165485 ·Status: COMPLETED ·Phase: PHASE4
-
Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2
NCT01662986 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease
NCT01072396 ·Status: COMPLETED ·Phase: PHASE4
-
Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva
NCT00274066 ·Status: COMPLETED ·Phase: PHASE3
-
Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema
NCT00570544 ·Status: COMPLETED
-
Spiriva® Assessment of FEV1 (SAFE)
NCT00277264 ·Status: COMPLETED ·Phase: PHASE3
-
Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)
NCT01857323 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma
NCT00152984 ·Status: COMPLETED ·Phase: PHASE4
-
A Randomised, Double-blind, Placebo-controlled, 12 Week Trial to Evaluate the Effect of Tiotropium Inhalation Capsules (Spiriva) on the Magnitude of Exercise, Measured Using an Accelerometer, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00144326 ·Status: COMPLETED ·Phase: PHASE3
-
Tiotropium (Spiriva) Rehabilitation Study
NCT00274521 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Proven Hyperinflation
NCT02172521 ·Status: COMPLETED