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An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE1

An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients

A 2-Stage, Single-Dose Study in Healthy Volunteers and COPD Patients With an Open Label Ipratropium Bromide Reference to Evaluate the Efficacy, Pharmacokinetics, and Safety Profile of Inhaled TV48108

NCT02315144•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV48108.

Eligibility

Age

20 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Stage 1 (Healthy Volunteers)
•Male or female 20 to 75 years of age, inclusive, weighing 50 to 80 kg with a body mass index (BMI) of less than 30 kg/m\^2.
•In good health as determined by medical and psychiatric history, physical examination, electrocardiogram (ECG), serum chemistry, hematology, urinalysis, and serology.
•Other criteria apply, please contact the investigator for more information
•Stage 2 (Chronic Obstructive Lung Disease (COPD) patients)
•Male or female; 40 to 75 years of age, inclusive with a minimum body weight of 40 kg
•Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack years at the screening visit
•Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines.
•Other criteria apply, please contact the investigator for more information

Exclusion Criteria

•Stage 1 (Healthy Volunteers)
•History or current evidence of a clinically significant or uncontrolled disease
•Any disorder that may interfere with the absorption, distribution, metabolism or excretion of study drugs.
•History of severe allergy to milk protein
•Active smokers or former smokers who quit within 3 months of the first dose of study drug. Former smokers with greater than five-pack years (ie, the equivalent of one pack per day for five years) are also excluded.
•Other criteria apply, please contact the investigator for more information
•Stage 2 (Chronic Obstructive Lung Disease (COPD) patients)
•Recent history of hospitalization due to an exacerbation of airway disease within 3 months
•Need for increased treatments of COPD within 6 weeks prior to the screening visit
•History of and/or current diagnosis of asthma
+2 more criteria

Locations (7)

Teva Investigational Site 13038

Medford, Oregon, United States

Teva Investigational Site 13039

Spartanburg, South Carolina, United States

Teva Investigational Site 78992

Clayton, Australia

Teva Investigational Site 78993

Daws Park, Australia

Teva Investigational Site 78991

Melbourne, Australia

Teva Investigational Site 79041

Auckland, New Zealand

Teva Investigational Site 79040

Christchurch, New Zealand

Key Dates

Start Date

April 1, 2015

Primary Completion Date

August 1, 2015

Completion Date

August 1, 2015

Last Updated

November 9, 2021

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

TV48108

DRUG

Placebo

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

View study

RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease