Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, bronchodilation
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.
Interventions
DRUGTV48108
TV48108 15, 60, 120 μg
DRUGPlacebo
Placebo Comparator
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h). | Day 1 (pre-dose, up to 12 hours post-dose) |
Secondary
| Measure | Time frame |
|---|---|
| Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1) | Day 1 (pre-dose, up to 12 hours post-dose) |
| Percentage of Participants with Adverse Events | 28 Days |
Countries
Australia, New Zealand, United States
Outcome results
None listed