Chronic Obstructive Pulmonary DiseasePhase 1NCT02315144
An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients
A Phase 1 study testing TV48108 in people with Chronic Obstructive Pulmonary Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 7 sites in 3 countries.
Trial summary
The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV48108. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- TV48108
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Apr 2015to Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Australia3 sites
Teva Investigational Site 78992
Clayton
Teva Investigational Site 78993
Daws Park
Teva Investigational Site 78991
Melbourne
United States2 sites
Teva Investigational Site 13038
Medford, Oregon
Teva Investigational Site 13039
Spartanburg, South Carolina
New Zealand2 sites
Teva Investigational Site 79041
Auckland
Teva Investigational Site 79040
Christchurch
About this study
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
The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV48108.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- TV48108, Placebo
- Keywords
- COPD, bronchodilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV48108Drug
Also called 48108
TV48108 15, 60, 120 μg
PlaceboDrug
Also called Matching placebo
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| TV48108 - Healthy Volunteers | Experimental | 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 Receives: Drug: TV48108 |
| Placebo - Healthy Volunteers | Placebo comparator | Placebo Receives: Drug: Placebo |
| TV48108 15 µg COPD | Experimental | 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. Receives: Drug: TV48108 |
| TV48108 60 µg COPD | Experimental | Stage 2 Receives: Drug: TV48108 |
| TV48108 120 µg COPD | Experimental | Stage 2 . Receives: Drug: TV48108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h).
Measured: Day 1 (pre-dose, up to 12 hours post-dose)
Secondary outcomes (2)
Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1)
Measured: Day 1 (pre-dose, up to 12 hours post-dose)
Percentage of Participants with Adverse Events
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315144
- Sponsor's protocol ID
- TV48108-COPD-10045
- Status last verified
- Nov 2021
- First submitted
- 9 Dec 2014
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02315144
- Acronym / sponsor ID
- TV48108-COPD-10045
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, bronchodilation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV48108.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TV48108 - Healthy Volunteers | Experimental | Drug: TV48108Stage 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 - Healthy Volunteers | Placebo comparator | Drug: PlaceboPlacebo |
| TV48108 15 µg COPD | Experimental | Drug: TV48108Stage 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. |
| TV48108 60 µg COPD | Experimental | Drug: TV48108Stage 2 |
| TV48108 120 µg COPD | Experimental | Drug: TV48108Stage 2 . |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TV48108Also: 48108TV48108 15, 60, 120 μg | Drug | TV48108 - Healthy Volunteers, TV48108 120 µg COPD, TV48108 15 µg COPD, TV48108 60 µg COPD |
| PlaceboAlso: Matching placeboPlacebo Comparator | Drug | Placebo - Healthy Volunteers |
Primary outcome
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)
2 secondary outcomes
Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1)
Time frame: Day 1 (pre-dose, up to 12 hours post-dose)
Percentage of Participants with Adverse Events
Time frame: 28 Days
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TV48108 in people with Chronic Obstructive Pulmonary Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.