Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02315144




Registration number
NCT02315144
Ethics application status
Date submitted
9/12/2014
Date registered
11/12/2014
Date last updated
9/11/2021

Titles & IDs
Public title
An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients
Scientific 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
Secondary ID [1] 0 0
TV48108-COPD-10045
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TV48108
Treatment: Drugs - Placebo

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

Placebo Comparator: Placebo - Healthy Volunteers - 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.

Experimental: TV48108 60 µg COPD - Stage 2

Experimental: TV48108 120 µg COPD - Stage 2 .


Treatment: Drugs: TV48108
TV48108 15, 60, 120 µg

Treatment: Drugs: Placebo
Placebo Comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h).
Timepoint [1] 0 0
Day 1 (pre-dose, up to 12 hours post-dose)
Secondary outcome [1] 0 0
Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1)
Timepoint [1] 0 0
Day 1 (pre-dose, up to 12 hours post-dose)
Secondary outcome [2] 0 0
Percentage of Participants with Adverse Events
Timepoint [2] 0 0
28 Days

Eligibility
Key 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
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 a1 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 78992 - Clayton
Recruitment hospital [2] 0 0
Teva Investigational Site 78993 - Daws Park
Recruitment hospital [3] 0 0
Teva Investigational Site 78991 - Melbourne
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Daws Park
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Oregon
Country [2] 0 0
United States of America
State/province [2] 0 0
South Carolina
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02315144
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Teva Medical Expert, MD
Address 0 0
Teva Branded Pharmaceutical Products R&D, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02315144