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Study in Healthy Volunteers and COPD Patients to Evaluate the Efficacy and Safety of Inhaled TV46017

NCT02315131 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-11-09

No results posted yet for this study

Summary

The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV46017

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD

Interventions

DRUG

TV46017

TV46017 15, 60, 120, and 240 μg; 4 ascending doses of inhaled TV46017 with an ipratropium bromide reference to evaluate the single administration of 4 ascending doses of inhaled TV46017 in COPD patients.

DRUG

Placebo

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
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02315131 on ClinicalTrials.gov