Clinical trial NCT02315131: Study in Healthy Volunteers and COPD Patients to Evaluate the Efficacy and Safety of Inhaled TV46017
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 TV46017
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease (COPD
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: Stage 1 Inclusion Criteria (healthy volunteers):

* The subject is a 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/m2. Note: Every effort should be made to enroll approximately equal numbers of men and women in each group.
* The subject is 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 Inclusion Criteria (COPD patients):

* Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack years at the SV (number of cigarette packs smoked per day multiplied by the number of years smoked; eg, 2 packs/day for 3 years equals a 6 pack year history).
* Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines.
* Male or female; 40 to 75 years of age, inclusive.
* Patient is free of any other medical conditions or concomitant treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
* Other criteria apply, please contact the investigator for more information

Stage 1 Exclusion Criteria (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 Exclusion Criteria (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 SV.
* Occurrence of a COPD exacerbation, which is not resolved by 4 weeks or more prior to the SV/informed consent. (Note: An exacerbation of COPD is defined as any worsening of the patient's baseline COPD symptoms requiring any treatment other than rescue albuterol or the patient's regular maintenance therapy. This includes requiring the use of systemic corticosteroids, antibiotics, and/or emergency room visit or hospitalization.)
* 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. A patient who, in the opinion of the investigator, has any other significant respiratory condition in addition to COPD should be excluded. Examples may include clinically significant noncystic bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. Allergic rhinitis is not exclusionary.
* Other criteria apply, please contact the investigator for more information

Primary outcomes:
measure: FEV1 AUC0-12h
timeFrame: Baseline, 12 hours
Secondary outcomes:
measure: FEV1
timeFrame: Baseline, 12 hours
measure: Percentage of Participants with Adverse Events
timeFrame: 28 Days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Teva Investigational Site 13033
state: Missouri
city: Raleigh
country: United States
facility: Teva Investigational Site 13034
state: North Carolina
city: Adelaide
country: Australia
facility: Teva Investigational Site 78984
city: Nedlands
country: Australia
facility: Teva Investigational Site 78985
city: Auckland
country: New Zealand
facility: Teva Investigational Site 79037
city: Hamilton
country: New Zealand
facility: Teva Investigational Site 79036
city: Wellington
country: New Zealand
facility: Teva Investigational Site 79034
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: