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Trial record 79 of 150 for:    Ipratropium OR atrovent

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

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ClinicalTrials.gov Identifier: NCT02315144
Recruitment Status : Terminated (Business decision)
First Posted : December 11, 2014
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: TV48108 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: TV48108 - Healthy Volunteers
Stage 1 is a randomized, placebo-controlled, double-blind, single-dose study. Healthy subjects will be randomized to receive a single inhaled dose of TV48108 120 µg
Drug: TV48108
TV48108 15, 60, 120 μg
Other Name: 48108

Placebo Comparator: Placebo - Healthy Volunteers
Placebo
Drug: Placebo
Placebo Comparator
Other Name: Matching placebo

Experimental: TV48108 15 µg COPD
Stage 2 consists of a 2-period open-label study with an ipratropium bromide reference to evaluate the single administration of 3 ascending doses of inhaled TV48108 in COPD patients.
Drug: TV48108
TV48108 15, 60, 120 μg
Other Name: 48108

Experimental: TV48108 60 µg COPD
Stage 2
Drug: TV48108
TV48108 15, 60, 120 μg
Other Name: 48108

Experimental: TV48108 120 µg COPD
Stage 2 .
Drug: TV48108
TV48108 15, 60, 120 μg
Other Name: 48108




Primary Outcome Measures :
  1. Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h). [ Time Frame: Day 1 (pre-dose, up to 12 hours post-dose) ]

Secondary Outcome Measures :
  1. Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1) [ Time Frame: Day 1 (pre-dose, up to 12 hours post-dose) ]
  2. Percentage of Participants with Adverse Events [ Time Frame: 28 Days ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  • Known α1 antitrypsin deficiency, active lung infections (such as tuberculosis or pneumonia), and lung cancer are absolute exclusionary conditions
  • Other criteria apply, please contact the investigator for more information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315144


Locations
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United States, Oregon
Teva Investigational Site 13038
Medford, Oregon, United States
United States, South Carolina
Teva Investigational Site 13039
Spartanburg, South Carolina, United States
Australia
Teva Investigational Site 78992
Clayton, Australia
Teva Investigational Site 78993
Daws Park, Australia
Teva Investigational Site 78991
Melbourne, Australia
New Zealand
Teva Investigational Site 79041
Auckland, New Zealand
Teva Investigational Site 79040
Christchurch, New Zealand
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02315144     History of Changes
Other Study ID Numbers: TV48108-COPD-10045
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015
Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):
COPD
bronchodilation
Additional relevant MeSH terms:
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Ipratropium
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action