Chronic Obstructive Pulmonary Disease (COPD)Phase 3COPDNCT02512510
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing TD-4208 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Mylan Inc. at 1 site in United States.
Trial summary
The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- TD-4208
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 611 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a male or female subject 40 years of age or older
Who cannot join
- Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Palmetto Medical Research Associates L.L.C.
Easley, South Carolina, 29640
About this study
Official title: A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.
- Being tested
- TD-4208, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- 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.
TD-4208Drug
Also called revefenacin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TD-4208-1 | Active comparator | 88 mcg Receives: Drug: TD-4208 |
| TD-4208-2 | Active comparator | 175 mcg Receives: Drug: TD-4208 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Trough FEV1 on Day 85
Measured: Baseline and Day 85
Secondary outcomes (5)
Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85
Measured: Days 15 to 85
Summary of Change From Baseline to Peak FEV1 After First Dose
Measured: 0-2 hours after First Dose Day 1
Summary of Rescue Medication Use: Puffs Per Day
Measured: 1-3 Months
St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85
A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units
Measured: Day 85
Percentage of Albuterol Rescue-free 24-hour Periods
Measured: 1-3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512510
- Sponsor's protocol ID
- 0127
- Acronym
- COPD
- Status last verified
- Feb 2022
- First submitted
- 28 Jul 2015
- Last updated
- 24 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
LeMaster WB, Witenko CJ, Lacy MK, Olmsted AW, Moran EJ, Mahler DA. Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD. Int J Chron Obstruct Pulmon Dis. 2024 Oct 16;19:2299-2308. doi: 10.2147/COPD.S483176. eCollection 2024.
PubMed 39429809Donohue JF, Ferguson GT, Ohar JA, Lombardi DA, Schneider RF, Johnson K. Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease. Respir Med. 2023 Mar;208:107123. doi: 10.1016/j.rmed.2023.107123. Epub 2023 Jan 18.
PubMed 36681255Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.
PubMed 33124005Donohue JF, Kerwin E, Barnes CN, Moran EJ, Haumann B, Crater GD. Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis. BMC Pulm Med. 2020 May 11;20(1):134. doi: 10.1186/s12890-020-1156-4.
PubMed 32393215
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02512510
- Acronym / sponsor ID
- COPD / 0127
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Posted 31 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TD-4208-1 | Active comparator | Drug: TD-420888 mcg |
| TD-4208-2 | Active comparator | Drug: TD-4208175 mcg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject is a male or female subject 40 years of age or older
Key exclusion criteria (1 listed)
- Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
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 |
|---|---|---|
| TD-4208Also: revefenacin | Drug | TD-4208-1, TD-4208-2 |
| Placebo | Drug | Placebo |
Primary outcome
Change From Baseline in Trough FEV1 on Day 85
Time frame: Baseline and Day 85
5 secondary outcomes
Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85
Time frame: Days 15 to 85
Summary of Change From Baseline to Peak FEV1 After First Dose
Time frame: 0-2 hours after First Dose Day 1
Summary of Rescue Medication Use: Puffs Per Day
Time frame: 1-3 Months
St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85
Time frame: Day 85
Percentage of Albuterol Rescue-free 24-hour Periods
Time frame: 1-3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39429809LeMaster WB, Witenko CJ, Lacy MK, Olmsted AW, Moran EJ, Mahler DA. Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD. Int J Chron Obstruct Pulmon Dis. 2024 Oct 16;19:2299-2308. doi: 10.2147/COPD.S483176. eCollection 2024.
- Derived from this study: PubMed 36681255Donohue JF, Ferguson GT, Ohar JA, Lombardi DA, Schneider RF, Johnson K. Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease. Respir Med. 2023 Mar;208:107123. doi: 10.1016/j.rmed.2023.107123. Epub 2023 Jan 18.
- Derived from this study: PubMed 33124005Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.
- Derived from this study: PubMed 32393215Donohue JF, Kerwin E, Barnes CN, Moran EJ, Haumann B, Crater GD. Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis. BMC Pulm Med. 2020 May 11;20(1):134. doi: 10.1186/s12890-020-1156-4.
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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.
Medical Monitor study director
Theravance Biopharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TD-4208 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Mylan Inc. at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Trough FEV1 on Day 85 (time frame: Baseline and Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02512510, which also lists 4 linked publications.
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 24 Feb 2022.